ClinicalTrials.gov
ClinicalTrials.gov Menu

CLOTBUST Hands-Free: A Phase I/II Pilot Safety Trial (CLOTBUST-HF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01240356
Recruitment Status : Completed
First Posted : November 15, 2010
Results First Posted : May 23, 2016
Last Update Posted : May 23, 2016
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by (Responsible Party):
James Grotta, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Stroke
Interventions Device: 2-MHz transcranial Doppler ultrasound
Device: 2-MHz transcranial Doppler ultrasound insonation
Enrollment 35

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phase I Phase II
Hide Arm/Group Description Non-stroke volunteers. Acute Ischemic Stroke patients received standard-doce intravenous tissue-type plasminogen activator (tPA) within 0-3 hours window.
Period Title: Overall Study
Started 18 20
Completed 15 20
Not Completed 3 0
Reason Not Completed
Withdrawal by Subject             2             0
MRI contraindication             1             0
Arm/Group Title Phase I Phase II Total
Hide Arm/Group Description Non-stroke volunteers. Phase II-20 patients with ischemic stroke treated with IV-tPA Total of all reporting groups
Overall Number of Baseline Participants 15 20 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 20 participants 35 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
  86.7%
12
  60.0%
25
  71.4%
>=65 years
2
  13.3%
8
  40.0%
10
  28.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 20 participants 35 participants
49  (16) 63  (14) 57  (17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 20 participants 35 participants
Female
9
  60.0%
8
  40.0%
17
  48.6%
Male
6
  40.0%
12
  60.0%
18
  51.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 20 participants 35 participants
15 20 35
1.Primary Outcome
Title Number of Participants in Phase I Group With Blood-brain-barrier Disruption (BBB) as Measured by MRI of the Brain
Hide Description Phase I : Imaging of the brain via MRI scans was performed to determine if the Hands-Free transcranial Doppler (TCD) system results in any BBB-disruption or deterioration in permeability.
Time Frame 2-3 hours after treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I
Hide Arm/Group Description:
Non stroke patients
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
0
2.Primary Outcome
Title Safety in Phase II Group as Measured by Incidence of Symptomatic Intracerebral Hemorrhage
Hide Description Phase II: Determine if the Hands-Free TCD will not result in higher than 10% rate of symptomatic intracerebral hemorrhage (ICH) within 24 hours (defined as clinical worsening > 4 NIH Stroke Scale (NIHSS) points and presence of hemorrhage on CT scan that in the opinion of the treating physician is causatively related to ICH on CT) in 0-3 hours acute stroke patients treated with intravenous tissue-type plasminogen activator (IV-t-PA).
Time Frame within 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat (ITT)
Arm/Group Title Phase II - Ischemic Stroke Patients
Hide Arm/Group Description:
Phase II - A group of 20 patients with ischemic stroke treated with IV-tPA
Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
0
(0 to 17)
3.Primary Outcome
Title Number of Participants in Phase I Group With Neurological Deterioration as Measured by Neurological Examination
Hide Description The neurological examinations comprised assessments of mental status and orientation, cranial nerve examination, muscle strength and tone, deep tendon reflexes, sensory testing, coordination, and gait.
Time Frame 2-3 hours after treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase I: Healthy Volunteers
Hide Arm/Group Description:
Phase I - A group of 15 Non-stroke healthy volunteers.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
0
4.Secondary Outcome
Title Number of Participants in Phase I Group With Adverse Events During and After Study Treatment With HF TCD
Hide Description Phase I - A group of healthy volunteers will be assessed to determine the feasibility and activity of hands-free (HF) transcranial Doppler (TCD). Adverse events include subject complaints regarding discomfort of the device and dermatological adverse events as evidenced by a detailed physical examination of skin integrity post-insonation.
Time Frame 2-3 hours after treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Phase 1 (Healthy Volunteers)
Hide Arm/Group Description:
Phase I - A group of non-stroke healthy volunteers.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
0
5.Secondary Outcome
Title Percentage of Participants in the Phase II Group That Show Arterial Recanalization as Measured Using Standard Transcranial Doppler Ultrasound Systems
Hide Description Ischemic stroke patients: 2-hour rates of arterial complete and partial recanalization as measured using standard Transcranial Doppler Ultrasound systems.
Time Frame 2-3 hours after treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT - Percent of patients who had complete recanalization after treatment.
Arm/Group Title Phase II - Iscehmic Stroke Patients
Hide Arm/Group Description:
Phase II - 20 patients with ischemic stroke treated with IV-tPA
Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
40
(19 to 64)
6.Secondary Outcome
Title Percentage of Participants in Phase II Group With Neurological Worsening as Determined by the NIH Stroke Scale
Hide Description The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used by healthcare providers to objectively quantify the impairment caused by a stroke. Each item on the NIHSS scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score being a 0.
Time Frame within 90 days of enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Phase II - Ischemic Stroke Patients
Hide Arm/Group Description:
Phase II - A group of 20 patients with ischemic stroke treated with IV-tPA
Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
5
(0 to 25)
7.Secondary Outcome
Title Percentage of Participants in Phase II Group With Excellent Outcome as Measured by Modified Rankin Scale (mRS)
Hide Description A modified Rankin Scale (mRS) score of 0 or 1 indicates an excellent outcome. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The mRS scale ranks patients from 0 to 6 (0 is the best score, 6 is the worst score).
Time Frame at 3-months from enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT with modified Ranking scores (mSR) at 90 days. % displayed is % with excellent outcome (mRS of 0-1).
Arm/Group Title Phase II - Ischemic Stroke Patients
Hide Arm/Group Description:
Phase II - A group of 20 patients with ischemic stroke treated with IV-tPA
Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
25
(7 to 49)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phase I: Healthy Volunteers Phase II - Ischemic Stroke Patients
Hide Arm/Group Description Phase I - 15 non-stroke healthy volunteers. Phase II - 20 patient with ischemic stroke treated with IV-tPA
All-Cause Mortality
Phase I: Healthy Volunteers Phase II - Ischemic Stroke Patients
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Phase I: Healthy Volunteers Phase II - Ischemic Stroke Patients
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      9/20 (45.00%)    
Infections and infestations     
Sepsis   0/15 (0.00%)  0 1/20 (5.00%)  1
Nervous system disorders     
Intracranial hemohhrage secondary to bacterial endocarditis   0/15 (0.00%)  0 1/20 (5.00%)  1
Death   0/15 (0.00%)  0 3/20 (15.00%)  3
Cerebral edema   0/15 (0.00%)  0 4/20 (20.00%)  4
Stroke progression/Nuero-worsening   0/15 (0.00%)  0 1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders     
Pneumonia/respiratory failure   0/15 (0.00%)  0 4/20 (20.00%)  4
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Phase I: Healthy Volunteers Phase II - Ischemic Stroke Patients
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      19/20 (95.00%)    
Blood and lymphatic system disorders     
Anemia/decreased hemoglobin and hematocrit   0/15 (0.00%)  0 6/20 (30.00%)  6
Electrolyze imbalance   0/15 (0.00%)  0 1/20 (5.00%)  1
Cardiac disorders     
Hypertension   0/15 (0.00%)  0 6/20 (30.00%)  6
Hypotension   0/15 (0.00%)  0 1/20 (5.00%)  1
Bradycardia   0/15 (0.00%)  0 2/20 (10.00%)  2
Tachycardia   0/15 (0.00%)  0 4/20 (20.00%)  4
Elevated CK   0/15 (0.00%)  0 1/20 (5.00%)  1
New diagnosis of PFO   0/15 (0.00%)  0 1/20 (5.00%)  1
Infections and infestations     
Fewer   0/15 (0.00%)  0 6/20 (30.00%)  6
Elevated white blood count   0/15 (0.00%)  0 5/20 (25.00%)  5
Utinary tract infection   0/15 (0.00%)  0 2/20 (10.00%)  2
Nervous system disorders     
Asymptomatic ICH   0/15 (0.00%)  0 6/20 (30.00%)  6
Elevated Coag lab test   0/15 (0.00%)  0 1/20 (5.00%)  1
Renal and urinary disorders     
Elevated Creatinine   0/15 (0.00%)  0 1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders     
Tachypnea   0/15 (0.00%)  0 4/20 (20.00%)  4
Right lung atelectasis   0/15 (0.00%)  0 1/20 (5.00%)  1
Positive sputum culture   0/15 (0.00%)  0 1/20 (5.00%)  1
Indicates events were collected by systematic assessment
The last phase (Phase II: 3-6 hour non-lytic patients who presented between 3-6 hours and with evidence of mismatch on neuroimaging), was not completed. This portion of the study was not started as new published evidence suggested little value.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: James C. Grotta, MD
Organization: The University of Texas Health Science Center at Houston
Phone: +1 (713) 500-7088
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: James Grotta, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01240356     History of Changes
Other Study ID Numbers: CLOTBUST-HF
First Submitted: November 8, 2010
First Posted: November 15, 2010
Results First Submitted: January 27, 2014
Results First Posted: May 23, 2016
Last Update Posted: May 23, 2016