Minimally Invasive Surgery and rtPA for Intracerebral Hemorrhage Evacuation (MISTIE)

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ClinicalTrials.gov Identifier: NCT00224770

Recruitment Status : Completed

First Posted : September 23, 2005

Results First Posted : June 18, 2015

Last Update Posted : June 18, 2015

Sponsor:

Collaborators:

National Institute of Neurological Disorders and Stroke (NINDS)

Genentech, Inc.

Emissary International LLC

Information provided by (Responsible Party):

Daniel Hanley, Johns Hopkins University

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Intracerebral Hemorrhage
Interventions	Drug: MIS+Cathflo Activase (drug) Procedure: Intraoperative stereotactic CT-Guided Endoscopic Surgery
Enrollment	141

Participant Flow

Recruitment Details	110 patients were randomized to the trial, and 31 were recruited as pilot patients.
Pre-assignment Details	Each study center was required to demonstrate proficiency in the technical aspects of enrollment, stabilization, surgery, and drug administration. This proficiency was demonstrated on at least one pilot patient prior to randomization of the first patient in the investigational cohort of 110 randomized patients.


Arm/Group Title	Medical Management	MISTIE Surgical Management	ICES Surgical Management
Arm/Group Description	Standard of care medical management...	Minimally invasive surgery (MIS) wi...	Intraoperative stereotactic CT-Guid...
Arm/Group Description	Standard of care medical management as per American Heart Association (AHA) guidelines.	Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA). MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care. This includes 54 intent-to-treat patients, and excludes 27 pilots.	Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES) Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered. This includes 14 intent-to-treat patients, and excludes 4 pilots.
Period Title: Overall Study
Started	42	54	14
Completed	38	52	14
Not Completed	4	2	0
Reason Not Completed
Lost to Follow-up	4	2	0

Baseline Characteristics

Arm/Group Title		Medical Management	MISTIE Surgical Management	ICES Surgical Management	Total
Arm/Group Description		Standard of care medical management...	Minimally invasive surgery (MIS) wi...	Intraoperative stereotactic CT-Guid...	Total of all reporting groups
Arm/Group Description		Standard of care medical management as per American Heart Association (AHA) guidelines.	Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA). MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo®) through the catheter once every eight hours for up to 72 hours, in addition to best medical care. This includes 54 intent-to-treat patients, and excludes 27 pilots.	Intraoperative stereotactic CT-Guided Endoscopic Surgery Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered. This includes 14 intent-to-treat patients, and excludes 4 pilots.	Total of all reporting groups
Overall Number of Baseline Participants		42	54	14	110
Baseline Analysis Population Description		...
Baseline Analysis Population Description		The decision was made to exclude the pilot patients from the analysis...
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	42 participants	54 participants	14 participants	110 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	18 42.9%	25 46.3%	9 64.3%	52 47.3%
	>=65 years	24 57.1%	29 53.7%	5 35.7%	58 52.7%
Age, Continuous Median (Inter-Quartile Range) Unit of measure: Years
	Number Analyzed	42 participants	54 participants	14 participants	110 participants
		62 (49.5 to 73)	60 (54 to 69)	59 (53.2 to 68.2)	61 (53.3 to 70)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	42 participants	54 participants	14 participants	110 participants
	Female	14 33.3%	19 35.2%	5 35.7%	38 34.5%
	Male	28 66.7%	35 64.8%	9 64.3%	72 65.5%
Region of Enrollment Measure Type: Number Unit of measure: Participants	Number Analyzed	42 participants	54 participants	14 participants	110 participants
United States		41	53	14	108
United Kingdom		1	1	0	2

Outcome Measures

1.Primary Outcome


Title	Safety Outcome Number 1: Rate of Mortality
Description	Percentage of participants who died during the first 30 days after ran...
Description	Percentage of participants who died during the first 30 days after randomization.
Time Frame	30 days from randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Medical Management	MISTIE Surgical Management	ICES Surgical Management
Arm/Group Description:	Standard of care medical management...	Minimally invasive surgery (MIS) wi...	Intraoperative stereotactic CT-Guid...
Arm/Group Description:	Standard of care medical management as per American Heart Association (AHA) guidelines.	Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA). MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care. This includes 54 intent-to-treat patients, and excludes 27 pilots.	Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES) Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered. This includes 14 intent-to-treat patients, and excludes 4 pilots.
Overall Number of Participants Analyzed	42	54	14
Measure Type: Number Number (90% Confidence Interval) Unit of Measure: percentage of participants
	9.5 (3.3 to 20.5)	14.8 (7.6 to 25.1)	7.1 (0.4 to 29.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Medical Management, MISTIE Surgical Management
	Comments	Null hypothesis is that rate of mortality within 30 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of mortality than the medical arm.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.324
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	One-sided test

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	5.3
	Confidence Interval	(1-Sided) 95% 16.2
	Parameter Dispersion	Type: Standard Error of the mean Value: 6.6
	Estimation Comments	MISTIE rate=14.8, 95% upper limit=25.1; medical rate=9.5, 95% upper limit=20.5; comparison considers MISTIE rate minus medical rate.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Medical Management, ICES Surgical Management
	Comments	Null hypothesis is that rate of mortality within 30 days is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher rate of mortality than the medical arm.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.633
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	One-sided test

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-2.4
	Confidence Interval	(1-Sided) 95% 11.2
	Parameter Dispersion	Type: Standard Error of the mean Value: 8.2
	Estimation Comments	ICES rate=7.1, 95% upper limit=29.7; medical rate=9.5, 95% upper limit=20.5; comparison considers ICES rate minus medical rate.

2.Primary Outcome


Title	Safety Outcome Number 2: Rate of Procedure-related Mortality
Description	Percentage of participants who died during the first 7 days after rand...
Description	Percentage of participants who died during the first 7 days after randomization.
Time Frame	7 days from randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Medical Management	MISTIE Surgical Management	ICES Surgical Management
Arm/Group Description:	Standard of care medical management...	Minimally invasive surgery (MIS) wi...	Intraoperative stereotactic CT-Guid...
Arm/Group Description:	Standard of care medical management as per American Heart Association (AHA) guidelines.	Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA). MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care. This includes 54 intent-to-treat patients, and excludes 27 pilots.	Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES) Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered. This includes 14 intent-to-treat patients, and excludes 4 pilots.
Overall Number of Participants Analyzed	42	54	14
Measure Type: Number Number (90% Confidence Interval) Unit of Measure: percentage of participants
	0 (0 to 6.9)	5.6 (1.5 to 13.7)	0 (0 to 19.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Medical Management, MISTIE Surgical Management
	Comments	Null hypothesis is that rate of procedure-related mortality within 7 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of procedure-related mortality than the medical arm.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.174
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	One-sided test

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	5.6
	Confidence Interval	(1-Sided) 95% 11.7
	Parameter Dispersion	Type: Standard Error of the mean Value: 3.1
	Estimation Comments	MISTIE rate=5.6, 95% upper limit=13.7; medical rate=0.0, 95% upper limit=6.9; comparison considers MISTIE rate minus medical rate.

3.Primary Outcome


Title	Safety Outcome Number 3: Rate of Cerebritis, Meningitis, Bacterial Ventriculitis
Description	Percentage of participants who had a bacterial brain infection (cerebr...
Description	Percentage of participants who had a bacterial brain infection (cerebritis, meningitis, ventriculitis) within 30 days of randomization.
Time Frame	30 days from randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Medical Management	MISTIE Surgical Management	ICES Surgical Management
Arm/Group Description:	Standard of care medical management...	Minimally invasive surgery (MIS) wi...	Intraoperative stereotactic CT-Guid...
Arm/Group Description:	Standard of care medical management as per American Heart Association (AHA) guidelines.	Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA). MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care. This includes 54 intent-to-treat patients, and excludes 27 pilots.	Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES) Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered. This includes 14 intent-to-treat patients, and excludes 4 pilots.
Overall Number of Participants Analyzed	42	54	14
Measure Type: Number Number (90% Confidence Interval) Unit of Measure: percentage of participants
	2.4 (0.1 to 10.8)	0 (0 to 5.4)	0 (0 to 19.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Medical Management, MISTIE Surgical Management
	Comments	Null hypothesis is that rate of cerebritis, meningitis and ventriculitis within 30 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of these infections than medical.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.437
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	One-sided test

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-2.4
	Confidence Interval	(1-Sided) 95% 1.5
	Parameter Dispersion	Type: Standard Error of the mean Value: 2.4
	Estimation Comments	MISTIE rate=0.0, 95% upper limit=5.4; medical rate=2.4, 95% upper limit=10.8; comparison considers MISTIE rate minus medical rate.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Medical Management, ICES Surgical Management
	Comments	Null hypothesis is that rate of cerebritis, meningitis and ventriculitis within 30 days is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher rate of these infections than medical.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.750
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	One-sided test

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-2.4
	Confidence Interval	(1-Sided) 95% 1.5
	Parameter Dispersion	Type: Standard Error of the mean Value: 2.4
	Estimation Comments	ICES rate=0.0, 95% upper limit=19.3; medical rate=2.4, 95% upper limit=10.8; comparison considers ICES rate minus medical rate.

4.Primary Outcome


Title	Safety Outcome Number 4: Rate of Symptomatic Rebleeding
Description	The difference in the rate of symptomatic rebleeding 72 hours post las...
Description	The difference in the rate of symptomatic rebleeding 72 hours post last dose.
Time Frame	72 hours post last dose

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Medical Management	MISTIE Surgical Management	ICES Surgical Management
Arm/Group Description:	Standard of care medical management...	Minimally invasive surgery (MIS) wi...	Intraoperative stereotactic CT-Guid...
Arm/Group Description:	Standard of care medical management as per American Heart Association (AHA) guidelines.	Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA). MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care. This includes 54 intent-to-treat patients, and excludes 27 pilots.	Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES) Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative targeting technique as the MISTIE arm. No rt-PA administered, and in addition to best medical care. This includes 14 intent-to-treat patients, and excludes 4 pilots.
Overall Number of Participants Analyzed	42	54	14
Measure Type: Number Number (90% Confidence Interval) Unit of Measure: percentage of participants
	2.4 (0.1 to 10.8)	5.6 (1.5 to 13.7)	0 (0 to 19.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Medical Management, MISTIE Surgical Management
	Comments	Null hypothesis is that rate of symptomatic rebleeding 72 hours post last dose is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher rate of symptomatic rebleeding than the medical arm.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.409
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	One-sided test

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	3.2
	Confidence Interval	(1-Sided) 95% 9.6
	Parameter Dispersion	Type: Standard Error of the mean Value: 3.9
	Estimation Comments	MISTIE rate=5.6, 95% upper limit=13.7; medical rate=2.4, 95% upper limit=10.8; comparison considers MISTIE rate minus medical rate

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Medical Management, ICES Surgical Management
	Comments	Null hypothesis is that rate of symptomatic rebleeding 72 hours post last dose is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher rate of symptomatic rebleeding than the medical arm.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.750
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	One-sided test

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	-2.4
	Confidence Interval	(1-Sided) 95% 2.2
	Parameter Dispersion	Type: Standard Error of the mean Value: 2.4
	Estimation Comments	ICES rate=0.0, 95% upper limit=19.3; medical rate=2.4, 95% upper limit=10.8; comparison considers ICES rate minus medical rate

5.Primary Outcome


Title	Efficacy Outcome Number 1: Dichotomized Modified Rankin Scale (mRS) at Day 180
Description	Percentage of participants with dichotomized mRS score in 0-3 range. T...
Description	Percentage of participants with dichotomized mRS score in 0-3 range. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead
Time Frame	180 days from randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Medical Management	MISTIE Surgical Management	ICES Surgical Management
Arm/Group Description:	Standard of care medical management...	Minimally invasive surgery (MIS) wi...	Intraoperative stereotactic CT-Guid...
Arm/Group Description:	Standard of care medical management as per American Heart Association (AHA) guidelines.	Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA). MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care. This includes 54 intent-to-treat patients, and excludes 27 pilots.	Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES) Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered. This includes 14 intent-to-treat patients, and excludes 4 pilots.
Overall Number of Participants Analyzed	38	52	14
Measure Type: Number Number (90% Confidence Interval) Unit of Measure: percentage of participants
	23.7 (12.9 to 37.7)	34.6 (23.7 to 46.9)	42.9 (20.6 to 67.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Medical Management, MISTIE Surgical Management
	Comments	Null hypothesis is that the proportion with mRS score of 0-3 at 180 days is the same between the two groups. The alternative hypothesis tests whether MISTIE surgical management has a higher proportion than the medical arm.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.189
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	One-sided test

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	10.9
	Confidence Interval	(1-Sided) 95% 26.6
	Parameter Dispersion	Type: Standard Error of the mean Value: 9.5
	Estimation Comments	MISTIE rate=34.6, 95% upper limit=46.9; medical rate=23.7, 95% upper limit=37.7; comparison considers MISTIE rate minus medical rate.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Medical Management, ICES Surgical Management
	Comments	Null hypothesis is that the proportion with mRS score of 0-3 at 180 days is the same between the two groups. The alternative hypothesis tests whether ICES surgical management has a higher proportion than the medical arm.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.156
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	One-sided test

Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	19.2
	Confidence Interval	(1-Sided) 95% 43.7
	Parameter Dispersion	Type: Standard Error of the mean Value: 14.9
	Estimation Comments	ICES rate=42.9, 95% upper limit=67.5; medical rate=23.7, 95% upper limit=37.7; comparison considers ICES rate minus medical rate.

6.Secondary Outcome


Title	Ordinal Modified Rankin Scale (mRS) at Day 180
Description	Ordinal distribution of the Modified Rankin Scale score at 180 days. T...
Description	Ordinal distribution of the Modified Rankin Scale score at 180 days. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead.
Time Frame	180 days from randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Medical Management	MISTIE Surgical Management	ICES Surgical Management
Arm/Group Description:	Standard of care medical management...	Minimally invasive surgery (MIS) wi...	Intraoperative stereotactic CT-Guid...
Arm/Group Description:	Standard of care medical management as per American Heart Association (AHA) guidelines.	Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA). MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care. This includes 54 intent-to-treat patients, and excludes 27 pilots.	Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES) Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered. This includes 14 intent-to-treat patients, and excludes 4 pilots.
Overall Number of Participants Analyzed	38	52	14
Median (Inter-Quartile Range) Unit of Measure: units on a scale
	4 (4 to 6)	4 (3 to 6)	4 (3 to 5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Medical Management, MISTIE Surgical Management
	Comments	Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.468
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	Two-sided test

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Medical Management, ICES Surgical Management
	Comments	Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.294
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	Two-sided test

7.Secondary Outcome


Title	Ordinal Modified Rankin Scale (mRS) at Day 365
Description	Ordinal distribution of the Modified Rankin Scale score at 365 days. T...
Description	Ordinal distribution of the Modified Rankin Scale score at 365 days. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead.
Time Frame	365 days from randomization

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Medical Management	MISTIE Surgical Management	ICES Surgical Management
Arm/Group Description:	Standard of care medical management...	Minimally invasive surgery (MIS) wi...	Intraoperative stereotactic CT-Guid...
Arm/Group Description:	Standard of care medical management as per American Heart Association (AHA) guidelines.	Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA). MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care. This includes 54 intent-to-treat patients, and excludes 27 pilots.	Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES) Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered. This includes 14 intent-to-treat patients, and excludes 4 pilots.
Overall Number of Participants Analyzed	24	20	12
Median (Inter-Quartile Range) Unit of Measure: units on a scale
	4.5 (3.5 to 6)	4 (2 to 6)	3.5 (3 to 5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Medical Management, MISTIE Surgical Management
	Comments	Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.395
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	Two-sided test

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Medical Management, ICES Surgical Management
	Comments	Null hypothesis is that the distributions of the mRS values for both groups are the same. The alternative hypothesis is that the distributions are not the same.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.175
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	Two-sided test

8.Secondary Outcome


Title	Clot Size Reduction by End of Treatment
Description	The percentage of blood clot resolved by the end of treatment CT scan ...
Description	The percentage of blood clot resolved by the end of treatment CT scan compared to the stability CT scan.
Time Frame	Time from randomization until end of treatment, up to 10 days

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Medical Management	MISTIE Surgical Management	ICES Surgical Management
Arm/Group Description:	Standard of care medical management...	Minimally invasive surgery (MIS) wi...	Intraoperative stereotactic CT-Guid...
Arm/Group Description:	Standard of care medical management as per American Heart Association (AHA) guidelines.	Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA). MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care. This includes 54 intent-to-treat patients, and excludes 27 pilots.	Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES) Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered. This includes 14 intent-to-treat patients, and excludes 4 pilots.
Overall Number of Participants Analyzed	42	54	14
Median (Inter-Quartile Range) Unit of Measure: percentage of blood clot resolved
	3.9 (-0.06 to 10.2)	64.3 (43.3 to 74.1)	69.5 (59.0 to 86.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Medical Management, MISTIE Surgical Management
	Comments	Null hypothesis is that the distributions of percentage of blood clot resolved are the same between the two groups. The alternative hypothesis is that the distributions are not the same.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	Two-sided test

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Medical Management, ICES Surgical Management
	Comments	Null hypothesis is that the distributions of percentage of blood clot resolved are the same between the two groups. The alternative hypothesis is that the distributions are not the same.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Wilcoxon (Mann-Whitney)
	Comments	Two-sided test

9.Secondary Outcome


Title	Post-operative Clot Size Reduction
Description	The percentage of blood clot resolved by the end of treatment CT scan ...
Description	The percentage of blood clot resolved by the end of treatment CT scan compared to the post-operative CT scan for surgical patients.
Time Frame	Time from post-operation until end of treatment, up to 10 days

Outcome Measure Data

Analysis Population Description

Analysis population only includes surgical patients.


Arm/Group Title	Medical Management	MISTIE Surgical Management	ICES Surgical Management
Arm/Group Description:	Standard of care medical management...	Minimally invasive surgery (MIS) wi...	Intraoperative stereotactic CT-Guid...
Arm/Group Description:	Standard of care medical management as per American Heart Association (AHA) guidelines.	Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA). MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care. This includes 54 intent-to-treat patients, and excludes 27 pilots.	Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES) Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered. This includes 14 intent-to-treat patients, and excludes 4 pilots.
Overall Number of Participants Analyzed	0	54	14
Median (Inter-Quartile Range) Unit of Measure: percentage of blood clot resolved
		56.7 (23.6 to 68.4)	-6.4 (-21.3 to 4.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MISTIE Surgical Management
	Comments	Null hypothesis is that the median percent resolved is 0. The alternative hypothesis is that the median percent resolved is not equal to 0.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.0001
	Comments	[Not Specified]
	Method	Sign test
	Comments	Two-sided test

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ICES Surgical Management
	Comments	Null hypothesis is that the median percent resolved is 0. The alternative hypothesis is that the median percent resolved is not equal to 0.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.791
	Comments	[Not Specified]
	Method	Sign test
	Comments	Two-sided

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Medical Management		MISTIE Surgical Management		ICES Surgical Management
Arm/Group Description	Standard of care medical management...		Minimally invasive surgery (MIS) wi...		Intraoperative stereotactic CT-Guid...
Arm/Group Description	Standard of care medical management as per American Heart Association (AHA) guidelines.		Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA). MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care. This includes 54 intent-to-treat patients, and excludes 27 pilots.		Intraoperative stereotactic CT-Guided Endoscopic Surgery Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered. This includes 14 intent-to-treat patients, and excludes 4 pilots.
All-Cause Mortality
	Medical Management		MISTIE Surgical Management		ICES Surgical Management
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--		--/--
Serious Adverse Events Serious Adverse Events
	Medical Management		MISTIE Surgical Management		ICES Surgical Management
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	23/42 (54.76%)		28/54 (51.85%)		6/14 (42.86%)
Cardiac disorders
Cardiac arrest ^†	3/42 (7.14%)	3	1/54 (1.85%)	1	1/14 (7.14%)	1
PVC's, bigemeny ^†	0/42 (0.00%)	0	0/54 (0.00%)	0	1/14 (7.14%)	1
Myocardial infarction ^†	2/42 (4.76%)	2	0/54 (0.00%)	0	0/14 (0.00%)	0
Sinus bradycardia ^†	1/42 (2.38%)	1	0/54 (0.00%)	0	0/14 (0.00%)	0
Gastrointestinal disorders
Diarrhea ^†	0/42 (0.00%)	0	1/54 (1.85%)	1	1/14 (7.14%)	1
Epistaxis ^†	0/42 (0.00%)	0	1/54 (1.85%)	2	0/14 (0.00%)	0
Duodenal ulcer ^†	1/42 (2.38%)	1	0/54 (0.00%)	0	0/14 (0.00%)	0
Gastric hemorrhage ^†	1/42 (2.38%)	1	0/54 (0.00%)	0	0/14 (0.00%)	0
General disorders
Death NOS ^†	2/42 (4.76%)	2	1/54 (1.85%)	1	1/14 (7.14%)	1
Sudden death NOS ^†	1/42 (2.38%)	1	0/54 (0.00%)	0	0/14 (0.00%)	0
Infections and infestations
Bacteremia ^†	0/42 (0.00%)	0	1/54 (1.85%)	1	0/14 (0.00%)	0
Catheter related infection ^†	0/42 (0.00%)	0	1/54 (1.85%)	1	0/14 (0.00%)	0
Lung infection ^†	0/42 (0.00%)	0	1/54 (1.85%)	1	0/14 (0.00%)	0
Endocarditis ^†	0/42 (0.00%)	0	1/54 (1.85%)	1	0/14 (0.00%)	0
Sepsis ^†	1/42 (2.38%)	1	3/54 (5.56%)	5	0/14 (0.00%)	0
Urinary tract infection ^†	0/42 (0.00%)	0	1/54 (1.85%)	1	0/14 (0.00%)	0
Enterocolitis infectious ^†	1/42 (2.38%)	1	0/54 (0.00%)	0	0/14 (0.00%)	0
Upper respiratory infection ^†	1/42 (2.38%)	1	0/54 (0.00%)	0	0/14 (0.00%)	0
Injury, poisoning and procedural complications
Intraoperative hemorrhage ^†	0/42 (0.00%)	0	1/54 (1.85%)	1	0/14 (0.00%)	0
Pulmonary embolism ^†	1/42 (2.38%)	1	1/54 (1.85%)	1	0/14 (0.00%)	0
Hip fracture ^†	0/42 (0.00%)	0	0/54 (0.00%)	0	1/14 (7.14%)	1
Metabolism and nutrition disorders
Dehydration ^†	0/42 (0.00%)	0	1/54 (1.85%)	1	0/14 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Left renal mass ^†	0/42 (0.00%)	0	1/54 (1.85%)	1	0/14 (0.00%)	0
Nervous system disorders
Depressed level of consciousness ^†	0/42 (0.00%)	0	3/54 (5.56%)	3	0/14 (0.00%)	0
Edema cerebral ^†	1/42 (2.38%)	1	1/54 (1.85%)	1	0/14 (0.00%)	0
Intracranial hemorrhage: Tissue, Enlargement ^†	1/42 (2.38%)	1	4/54 (7.41%)	4	0/14 (0.00%)	0
Intracranial hemorrhage: Tissue, New ^†	0/42 (0.00%)	0	2/54 (3.70%)	2	0/14 (0.00%)	0
Intracranial hemorrhage: Ventricular system, New ^†	0/42 (0.00%)	0	1/54 (1.85%)	1	0/14 (0.00%)	0
Intracranial hypertension ^†	4/42 (9.52%)	4	2/54 (3.70%)	3	0/14 (0.00%)	0
Ischemia cerebrovascular ^†	4/42 (9.52%)	4	3/54 (5.56%)	3	0/14 (0.00%)	0
Syncope ^†	1/42 (2.38%)	2	0/54 (0.00%)	0	0/14 (0.00%)	0
Anoxic brain injury ^†	1/42 (2.38%)	1	0/54 (0.00%)	0	0/14 (0.00%)	0
Seizure ^†	2/42 (4.76%)	3	1/54 (1.85%)	1	0/14 (0.00%)	0
Stroke ^†	0/42 (0.00%)	0	1/54 (1.85%)	1	0/14 (0.00%)	0
Cerebrospinal fluid leakage ^†	0/42 (0.00%)	0	0/54 (0.00%)	0	1/14 (7.14%)	1
Intracranial hemorrhage: Catheter Tract, New ^†	0/42 (0.00%)	0	0/54 (0.00%)	0	1/14 (7.14%)	1
Intracranial hemorrhage: Catheter Tract, Enlargement ^†	0/42 (0.00%)	0	0/54 (0.00%)	0	1/14 (7.14%)	1
Intracranial hemorrhage: Ventricular system, Enlargement ^†	1/42 (2.38%)	1	0/54 (0.00%)	0	1/14 (7.14%)	2
Herniation ^†	1/42 (2.38%)	1	0/54 (0.00%)	0	0/14 (0.00%)	0
Hydrocephalus ^†	1/42 (2.38%)	1	0/54 (0.00%)	0	0/14 (0.00%)	0
Somnolence ^†	1/42 (2.38%)	1	0/54 (0.00%)	0	0/14 (0.00%)	0
Renal and urinary disorders
Acute kidney injury ^†	0/42 (0.00%)	0	1/54 (1.85%)	1	0/14 (0.00%)	0
Urinary retention ^†	0/42 (0.00%)	0	1/54 (1.85%)	1	0/14 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome ^†	2/42 (4.76%)	2	3/54 (5.56%)	3	0/14 (0.00%)	0
Aspiration ^†	1/42 (2.38%)	1	1/54 (1.85%)	1	0/14 (0.00%)	0
Hypoxia ^†	0/42 (0.00%)	0	1/54 (1.85%)	1	0/14 (0.00%)	0
Respiratory arrest ^†	0/42 (0.00%)	0	1/54 (1.85%)	1	0/14 (0.00%)	0
Pneumonitits ^†	1/42 (2.38%)	1	5/54 (9.26%)	5	1/14 (7.14%)	1
Respiratory failure ^†	5/42 (11.90%)	5	6/54 (11.11%)	6	0/14 (0.00%)	0
Ventilatory failure ^†	0/42 (0.00%)	0	1/54 (1.85%)	1	0/14 (0.00%)	0
Vascular disorders
Hypertension ^†	0/42 (0.00%)	0	2/54 (3.70%)	3	0/14 (0.00%)	0
Hypotension ^†	0/42 (0.00%)	0	1/54 (1.85%)	1	0/14 (0.00%)	0
Thromboembolic event ^†	3/42 (7.14%)	3	0/54 (0.00%)	0	0/14 (0.00%)	0
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Medical Management		MISTIE Surgical Management		ICES Surgical Management
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	24/42 (57.14%)		41/54 (75.93%)		8/14 (57.14%)
Blood and lymphatic system disorders
Leukocytosis ^†	1/42 (2.38%)	1	4/54 (7.41%)	4	0/14 (0.00%)	0
Anemia ^†	0/42 (0.00%)	0	8/54 (14.81%)	11	0/14 (0.00%)	0
Cardiac disorders
Atrial fibrillation ^†	2/42 (4.76%)	2	1/54 (1.85%)	1	0/14 (0.00%)	0
Sinus bradycardia ^†	2/42 (4.76%)	2	0/54 (0.00%)	0	0/14 (0.00%)	0
Gastrointestinal disorders
Constipation ^†	0/42 (0.00%)	0	5/54 (9.26%)	6	1/14 (7.14%)	1
Diarrhea ^†	0/42 (0.00%)	0	3/54 (5.56%)	3	0/14 (0.00%)	0
General disorders
Fever ^†	6/42 (14.29%)	6	13/54 (24.07%)	14	3/14 (21.43%)	3
Pain ^†	2/42 (4.76%)	2	2/54 (3.70%)	2	0/14 (0.00%)	0
Localized edema ^†	0/42 (0.00%)	0	3/54 (5.56%)	3	0/14 (0.00%)	0
HCAP ^†	0/42 (0.00%)	0	0/54 (0.00%)	0	1/14 (7.14%)	1
Infections and infestations
Lung infection ^†	2/42 (4.76%)	3	1/54 (1.85%)	1	1/14 (7.14%)	1
Urinary tract infection ^†	5/42 (11.90%)	6	9/54 (16.67%)	9	0/14 (0.00%)	0
Injury, poisoning and procedural complications
Fall ^†	0/42 (0.00%)	0	0/54 (0.00%)	0	1/14 (7.14%)	1
Metabolism and nutrition disorders
Hyperglycemia ^†	1/42 (2.38%)	1	4/54 (7.41%)	4	0/14 (0.00%)	0
Hypocalcemia ^†	2/42 (4.76%)	2	4/54 (7.41%)	4	0/14 (0.00%)	0
Hypoglycemia ^†	2/42 (4.76%)	3	1/54 (1.85%)	1	0/14 (0.00%)	0
Hypokalemia ^†	1/42 (2.38%)	1	6/54 (11.11%)	6	0/14 (0.00%)	0
Hypomagnesemia ^†	1/42 (2.38%)	1	3/54 (5.56%)	3	0/14 (0.00%)	0
Hyponatremia ^†	1/42 (2.38%)	1	4/54 (7.41%)	4	0/14 (0.00%)	0
Hyperkalemia ^†	0/42 (0.00%)	0	3/54 (5.56%)	3	0/14 (0.00%)	0
Hypernatremia ^†	0/42 (0.00%)	0	4/54 (7.41%)	4	0/14 (0.00%)	0
Hypophosphatemia ^†	0/42 (0.00%)	0	4/54 (7.41%)	4	0/14 (0.00%)	0
Nervous system disorders
Seizure ^†	3/42 (7.14%)	5	4/54 (7.41%)	4	0/14 (0.00%)	0
Intracranial hemorrhage: Catheter Tract, Enlargement ^†	0/42 (0.00%)	0	3/54 (5.56%)	4	0/14 (0.00%)	0
Intracranial hemorrhage: Catheter Tract, New ^†	0/42 (0.00%)	0	6/54 (11.11%)	6	0/14 (0.00%)	0
Intracranial hemorrhage: Tissue, Enlargement ^†	0/42 (0.00%)	0	3/54 (5.56%)	4	0/14 (0.00%)	0
Intracranial hemorrhage: Ventricular system, Enlargement ^†	0/42 (0.00%)	0	3/54 (5.56%)	3	0/14 (0.00%)	0
Wound reclosure after serious fluid leak ^†	0/42 (0.00%)	0	0/54 (0.00%)	0	1/14 (7.14%)	1
Renal and urinary disorders
Acute renal failure ^†	1/42 (2.38%)	1	3/54 (5.56%)	3	0/14 (0.00%)	0
Hematuria ^†	2/42 (4.76%)	2	1/54 (1.85%)	1	0/14 (0.00%)	0
Urinary retention ^†	1/42 (2.38%)	1	3/54 (5.56%)	3	0/14 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Aspiration ^†	5/42 (11.90%)	5	1/54 (1.85%)	1	0/14 (0.00%)	0
Atelectasis ^†	1/42 (2.38%)	1	3/54 (5.56%)	3	0/14 (0.00%)	0
Pneumonitis ^†	7/42 (16.67%)	7	6/54 (11.11%)	6	2/14 (14.29%)	2
Ventilatory failure ^†	1/42 (2.38%)	1	3/54 (5.56%)	3	0/14 (0.00%)	0
Pleural effusion ^†	0/42 (0.00%)	0	5/54 (9.26%)	5	0/14 (0.00%)	0
Vascular disorders
Hypertension ^†	4/42 (9.52%)	4	6/54 (11.11%)	6	0/14 (0.00%)	0
Thromboembolic event ^†	1/42 (2.38%)	1	5/54 (9.26%)	5	0/14 (0.00%)	0
Hypotension ^†	0/42 (0.00%)	0	3/54 (5.56%)	5	0/14 (0.00%)	0
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The only disclosure restriction on the PI is that the funding agency (NIH/NINDS) can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the funding agency for review. The funding agency cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Dr. Daniel F. Hanley
Organization:	Johns Hopkins University
Phone:	(410) 614-6996
EMail:	dhanley@jhmi.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hansen BM, Ullman N, Muschelli J, Norrving B, Dlugash R, Avadhani R, Awad I, Zuccarello M, Ziai WC, Hanley DF, Thompson RE, Lindgren A; MISTIE and CLEAR Investigators. Relationship of White Matter Lesions with Intracerebral Hemorrhage Expansion and Functional Outcome: MISTIE II and CLEAR III. Neurocrit Care. 2020 Oct;33(2):516-524. doi: 10.1007/s12028-020-00916-4.

Vespa P, Hanley D, Betz J, Hoffer A, Engh J, Carter R, Nakaji P, Ogilvy C, Jallo J, Selman W, Bistran-Hall A, Lane K, McBee N, Saver J, Thompson RE, Martin N; ICES Investigators. ICES (Intraoperative Stereotactic Computed Tomography-Guided Endoscopic Surgery) for Brain Hemorrhage: A Multicenter Randomized Controlled Trial. Stroke. 2016 Nov;47(11):2749-2755. Epub 2016 Oct 6. Erratum in: Stroke. 2017 Nov;48(11):e335.

Hanley DF, Thompson RE, Muschelli J, Rosenblum M, McBee N, Lane K, Bistran-Hall AJ, Mayo SW, Keyl P, Gandhi D, Morgan TC, Ullman N, Mould WA, Carhuapoma JR, Kase C, Ziai W, Thompson CB, Yenokyan G, Huang E, Broaddus WC, Graham RS, Aldrich EF, Dodd R, Wijman C, Caron JL, Huang J, Camarata P, Mendelow AD, Gregson B, Janis S, Vespa P, Martin N, Awad I, Zuccarello M; MISTIE Investigators. Safety and efficacy of minimally invasive surgery plus alteplase in intracerebral haemorrhage evacuation (MISTIE): a randomised, controlled, open-label, phase 2 trial. Lancet Neurol. 2016 Nov;15(12):1228-1237. doi: 10.1016/S1474-4422(16)30234-4. Epub 2016 Oct 11.

Muschelli J, Ullman NL, Sweeney EM, Eloyan A, Martin N, Vespa P, Hanley DF, Crainiceanu CM. Quantitative Intracerebral Hemorrhage Localization. Stroke. 2015 Nov;46(11):3270-3. doi: 10.1161/STROKEAHA.115.010369. Epub 2015 Oct 8.

Webb AJ, Ullman NL, Morgan TC, Muschelli J, Kornbluth J, Awad IA, Mayo S, Rosenblum M, Ziai W, Zuccarrello M, Aldrich F, John S, Harnof S, Lopez G, Broaddus WC, Wijman C, Vespa P, Bullock R, Haines SJ, Cruz-Flores S, Tuhrim S, Hill MD, Narayan R, Hanley DF; MISTIE and CLEAR Investigators. Accuracy of the ABC/2 Score for Intracerebral Hemorrhage: Systematic Review and Analysis of MISTIE, CLEAR-IVH, and CLEAR III. Stroke. 2015 Sep;46(9):2470-6. doi: 10.1161/STROKEAHA.114.007343. Epub 2015 Aug 4. Review.

Layout table for additonal information

Responsible Party:	Daniel Hanley, Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00224770
Other Study ID Numbers:	ICH01 R01NS046309 ( U.S. NIH Grant/Contract )
First Submitted:	September 21, 2005
First Posted:	September 23, 2005
Results First Submitted:	September 21, 2014
Results First Posted:	June 18, 2015
Last Update Posted:	June 18, 2015

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