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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01240356
First Posted: November 15, 2010
Last Update Posted: May 23, 2016
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.
Collaborator:
University of Alabama at Birmingham
Information provided by (Responsible Party):
James Grotta, The University of Texas Health Science Center, Houston
Results First Submitted: January 27, 2014  
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

  Participant Flow
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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
Phase I Non-stroke volunteers.
Phase II Acute Ischemic Stroke patients received standard-doce intravenous tissue-type plasminogen activator (tPA) within 0-3 hours window.

Participant Flow:   Overall Study
    Phase I   Phase II
STARTED   18   20 
COMPLETED   15   20 
NOT COMPLETED   3   0 
Withdrawal by Subject                2                0 
MRI contraindication                1                0 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Phase I Non-stroke volunteers.
Phase II Phase II-20 patients with ischemic stroke treated with IV-tPA
Total Total of all reporting groups

Baseline Measures
   Phase I   Phase II   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   20   35 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   13   12   25 
>=65 years   2   8   10 
Age 
[Units: Years]
Mean (Standard Deviation)
 49  (16)   63  (14)   57  (17) 
Gender 
[Units: Participants]
     
Female   9   8   17 
Male   6   12   18 
Region of Enrollment 
[Units: Participants]
     
United States   15   20   35 


  Outcome Measures
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1.  Primary:   Number of Participants in Phase I Group With Blood-brain-barrier Disruption (BBB) as Measured by MRI of the Brain   [ Time Frame: 2-3 hours after treatment ]

Measure Type Primary
Measure Title Number of Participants in Phase I Group With Blood-brain-barrier Disruption (BBB) as Measured by MRI of the Brain
Measure 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  

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.
No text entered.

Reporting Groups
  Description
Phase I Non stroke patients

Measured Values
   Phase I 
Participants Analyzed 
[Units: Participants]
 15 
Number of Participants in Phase I Group With Blood-brain-barrier Disruption (BBB) as Measured by MRI of the Brain 
[Units: Participants]
 0 

No statistical analysis provided for Number of Participants in Phase I Group With Blood-brain-barrier Disruption (BBB) as Measured by MRI of the Brain



2.  Primary:   Safety in Phase II Group as Measured by Incidence of Symptomatic Intracerebral Hemorrhage   [ Time Frame: within 24 hours ]

Measure Type Primary
Measure Title Safety in Phase II Group as Measured by Incidence of Symptomatic Intracerebral Hemorrhage
Measure 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  

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.
Intention to Treat (ITT)

Reporting Groups
  Description
Phase II - Ischemic Stroke Patients Phase II - A group of 20 patients with ischemic stroke treated with IV-tPA

Measured Values
   Phase II - Ischemic Stroke Patients 
Participants Analyzed 
[Units: Participants]
 20 
Safety in Phase II Group as Measured by Incidence of Symptomatic Intracerebral Hemorrhage 
[Units: Percentage of patients]
Number (95% Confidence Interval)
 0 
 (0 to 17) 

No statistical analysis provided for Safety in Phase II Group as Measured by Incidence of Symptomatic Intracerebral Hemorrhage



3.  Primary:   Number of Participants in Phase I Group With Neurological Deterioration as Measured by Neurological Examination   [ Time Frame: 2-3 hours after treatment ]

Measure Type Primary
Measure Title Number of Participants in Phase I Group With Neurological Deterioration as Measured by Neurological Examination
Measure 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  

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.
No text entered.

Reporting Groups
  Description
Phase I: Healthy Volunteers Phase I - A group of 15 Non-stroke healthy volunteers.

Measured Values
   Phase I: Healthy Volunteers 
Participants Analyzed 
[Units: Participants]
 15 
Number of Participants in Phase I Group With Neurological Deterioration as Measured by Neurological Examination 
[Units: Participants]
 0 

No statistical analysis provided for Number of Participants in Phase I Group With Neurological Deterioration as Measured by Neurological Examination



4.  Secondary:   Number of Participants in Phase I Group With Adverse Events During and After Study Treatment With HF TCD   [ Time Frame: 2-3 hours after treatment ]

Measure Type Secondary
Measure Title Number of Participants in Phase I Group With Adverse Events During and After Study Treatment With HF TCD
Measure 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  

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.
ITT

Reporting Groups
  Description
Phase 1 (Healthy Volunteers) Phase I - A group of non-stroke healthy volunteers.

Measured Values
   Phase 1 (Healthy Volunteers) 
Participants Analyzed 
[Units: Participants]
 15 
Number of Participants in Phase I Group With Adverse Events During and After Study Treatment With HF TCD 
[Units: Participants]
 0 

No statistical analysis provided for Number of Participants in Phase I Group With Adverse Events During and After Study Treatment With HF TCD



5.  Secondary:   Percentage of Participants in the Phase II Group That Show Arterial Recanalization as Measured Using Standard Transcranial Doppler Ultrasound Systems   [ Time Frame: 2-3 hours after treatment ]

Measure Type Secondary
Measure Title Percentage of Participants in the Phase II Group That Show Arterial Recanalization as Measured Using Standard Transcranial Doppler Ultrasound Systems
Measure 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  

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.
ITT - Percent of patients who had complete recanalization after treatment.

Reporting Groups
  Description
Phase II - Iscehmic Stroke Patients Phase II - 20 patients with ischemic stroke treated with IV-tPA

Measured Values
   Phase II - Iscehmic Stroke Patients 
Participants Analyzed 
[Units: Participants]
 20 
Percentage of Participants in the Phase II Group That Show Arterial Recanalization as Measured Using Standard Transcranial Doppler Ultrasound Systems 
[Units: Percentage of patients]
Number (95% Confidence Interval)
 40 
 (19 to 64) 

No statistical analysis provided for Percentage of Participants in the Phase II Group That Show Arterial Recanalization as Measured Using Standard Transcranial Doppler Ultrasound Systems



6.  Secondary:   Percentage of Participants in Phase II Group With Neurological Worsening as Determined by the NIH Stroke Scale   [ Time Frame: within 90 days of enrollment ]

Measure Type Secondary
Measure Title Percentage of Participants in Phase II Group With Neurological Worsening as Determined by the NIH Stroke Scale
Measure 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  

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.
No text entered.

Reporting Groups
  Description
Phase II - Ischemic Stroke Patients Phase II - A group of 20 patients with ischemic stroke treated with IV-tPA

Measured Values
   Phase II - Ischemic Stroke Patients 
Participants Analyzed 
[Units: Participants]
 20 
Percentage of Participants in Phase II Group With Neurological Worsening as Determined by the NIH Stroke Scale 
[Units: Percentage of patients]
Number (95% Confidence Interval)
 5 
 (0 to 25) 

No statistical analysis provided for Percentage of Participants in Phase II Group With Neurological Worsening as Determined by the NIH Stroke Scale



7.  Secondary:   Percentage of Participants in Phase II Group With Excellent Outcome as Measured by Modified Rankin Scale (mRS)   [ Time Frame: at 3-months from enrollment ]

Measure Type Secondary
Measure Title Percentage of Participants in Phase II Group With Excellent Outcome as Measured by Modified Rankin Scale (mRS)
Measure 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  

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.
ITT with modified Ranking scores (mSR) at 90 days. % displayed is % with excellent outcome (mRS of 0-1).

Reporting Groups
  Description
Phase II - Ischemic Stroke Patients Phase II - A group of 20 patients with ischemic stroke treated with IV-tPA

Measured Values
   Phase II - Ischemic Stroke Patients 
Participants Analyzed 
[Units: Participants]
 20 
Percentage of Participants in Phase II Group With Excellent Outcome as Measured by Modified Rankin Scale (mRS) 
[Units: Percentage of patients]
Number (95% Confidence Interval)
 25 
 (7 to 49) 

No statistical analysis provided for Percentage of Participants in Phase II Group With Excellent Outcome as Measured by Modified Rankin Scale (mRS)




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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.


  More Information
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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
e-mail: james.c.grotta@uth.tmc.edu


Publications of Results:
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