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The Spot Sign for Predicting and Treating ICH Growth Study (STOP-IT)

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ClinicalTrials.gov Identifier: NCT00810888
Recruitment Status : Completed
First Posted : December 18, 2008
Results First Posted : January 8, 2018
Last Update Posted : March 16, 2018
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Matthew Flaherty, University of Cincinnati

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Intracerebral Hemorrhage
Interventions: Drug: recombinant activated factor VII
Drug: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group 1 - Randomized to Study Drug

Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo .

Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).

Group 2 - Randomized to Placebo

Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).

Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)

Group 3 - Observation Only Arm Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA “spot sign” negative) will be enrolled into a prospective observational group.

Participant Flow:   Overall Study
    Group 1 - Randomized to Study Drug   Group 2 - Randomized to Placebo   Group 3 - Observation Only Arm
STARTED   10   9   73 
COMPLETED   10   9   73 
NOT COMPLETED   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The baseline population consists of 19 subjects diagnosed as "Spot Positive" on CT and were eligible for randomization within the clinical trial portion of the protocol. In addition 73 subjects diagnosed as "Spot Negative" on CT were followed prospectively with no study intervention. All 92 subjects were followed to 90 days post stroke.

Reporting Groups
  Description
Group 1 - Randomized to Study Drug

Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg) or a placebo .

Recombinant activated factor VII: Participants will receive rFVIIa at 80 mcg/kg (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).

Group 2 - Randomized to Placebo

Participants with ICH who are determined by CTA to be at high risk for hemorrhage growth (or determined to be CTA "spot sign" positive for contrast leakage within the brain hematoma) will be randomized to receive either rFVIIa at 80 mcg/kg or a placebo (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg).

Placebo: An inactive substance (maximum dose volume 21.3 mL, equivalent to maximum weight of 160 kg)

Group 3 - Observation Only Arm Participants with ICH who are determined by CTA not to be at high risk for hemorrhage growth (determined to be CTA “spot sign” negative) will be enrolled into a prospective observational group.
Total Total of all reporting groups

Baseline Measures
   Group 1 - Randomized to Study Drug   Group 2 - Randomized to Placebo   Group 3 - Observation Only Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   9   73   92 
Age 
[Units: Years]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 10   9   73   92 
   65.4  (13.1)   62.4  (12.2)   60.7  (34.7)   61.3  (11.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 10   9   73   92 
Female      6  60.0%      3  33.3%      29  39.7%      38  41.3% 
Male      4  40.0%      6  66.7%      44  60.3%      54  58.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 10   9   73   92 
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1  10.0%      5  55.6%      17  23.3%      23  25.0% 
White      9  90.0%      4  44.4%      56  76.7%      69  75.0% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
Canada         
Participants Analyzed 
[Units: Participants]
 10   9   73   92 
Canada   3   1   23   27 
United States         
Participants Analyzed 
[Units: Participants]
 10   9   73   92 
United States   7   8   50   65 
Modified Rankin Score (mRS) [1] 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 10   9   73   92 
    10 100.0%      6  66.7%      65  89.0%      81  88.0% 
    0   0.0%      3  33.3%      6   8.2%      9   9.8% 
    0   0.0%      0   0.0%      2   2.7%      2   2.2% 
[1] Measure of mobility prior to stroke (0=best, 5=worst)
Glasgow Coma Score/Scale (GCS) [1] 
[Units: Units on a scale]
Median (Inter-Quartile Range)
       
Participants Analyzed 
[Units: Participants]
 10   9   73   92 
   15 
 (14 to 15) 
 15 
 (14 to 15) 
 15 
 (14 to 15) 
 15 
 (14 to 15) 
[1] Scale to measure severity due to coma status (0=worst, 15=best)
National Institute of Health Stroke Scale (NIHSS) Score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 10   9   73   92 
   14.1  (3.9)   12.1  (4.9)   10.3  (6.2)   10.9  (6.0) 
[1] The National Institute of Health Stroke Scale (NIHSS) Score is a scale which measures stroke severity (0=best, 42=worst)
Time from Stroke to Computed Tomography (CT) Scan 
[Units: Minutes]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 10   9   73   92 
   158.8  (77.0)   90.2  (49.9)   159.8  (81.9)   152.9  (80.9) 
Time from Stroke to Study Drug Administration [1] 
[Units: Minutes]
Mean (Standard Deviation)
       
Participants Analyzed 
[Units: Participants]
 10   9   0   19 
   269.9  (68.3)   181.1  (47.1)      222.5  (70.4) 
[1] The Observational group did not receive study drug so the variable "Time from stroke to study drug administration" is not applicable


  Outcome Measures

1.  Primary:   Number of Study Subjects With Life-threatening Thromboembolic Complications   [ Time Frame: through day 4 after completion of study drug administration ]

2.  Primary:   Number of Subjects With Hematoma Growth Among Spot Sign Positive Subjects at 24 Hours.   [ Time Frame: From baseline to 24 hours ]

3.  Primary:   The Sensitivity of the Spot Sign for Predicting Hematoma Growth   [ Time Frame: Baseline head CT scan within 5 hours of stroke, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours. ]

4.  Primary:   The Specificity of the Spot Sign for Predicting Hematoma Growth   [ Time Frame: Baseline head CT scan within 5 hours of stroke, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours. ]

5.  Secondary:   Number of Participants With Other Potentially Study Drug Related Thromboembolic Complications Such as Deep Venous Thrombosis (DVT) and Elevations in Troponin Not Associated With ECG Changes   [ Time Frame: through day 4 after completion of study drug ]

6.  Secondary:   Number of Spot Positive Subjects With 90-day Outcome of Modified Rankin Scale Score >= 5   [ Time Frame: 90 days (+/- 7 days) from time of study enrollment ]

7.  Secondary:   Number of Participants With Agreement Between the Clinical Site Radiologists and the Study Radiologist With Respect to Identification of a Positive Spot Sign or the Absence of Positive Spot Sign on CTA   [ Time Frame: Baseline head CT scan within 5 hours, followed by a CT angiogram. Hematoma growth determined by comparison with a head CT scan performed at 24 hours. ]

8.  Secondary:   Percent Change in Total Hemorrhage Volume (Intracerebral Hemorrhage (ICH) Plus Intraventricular Hemorrhage (IVH)).   [ Time Frame: 24 hours (+/- 3 hours) from baseline CT scan ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr Jane Khoury, Professor of Pediatrics
Organization: Division of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center
phone: 513-636-2690
e-mail: jane.khoury@cchmc.org



Responsible Party: Matthew Flaherty, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00810888     History of Changes
Other Study ID Numbers: P50NS044283_STOP_IT
2P50NS044283 ( U.S. NIH Grant/Contract )
First Submitted: December 15, 2008
First Posted: December 18, 2008
Results First Submitted: September 22, 2017
Results First Posted: January 8, 2018
Last Update Posted: March 16, 2018