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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
  Show All Outcome Measures

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 ]

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

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

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 ]

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 ]

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 ]

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


  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