Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00283088
Status:
COMPLETED
Last Update Posted:
2011-01-12
First Post:
2006-01-26
Brief Title:
Intravenous Thrombolysis Plus Hypothermia for Acute Treatment of Ischemic Stroke
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Phase 1 Study of Intravenous Thrombolysis Plus Hypothermia for Acute Treatment of Ischemic Stroke
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to evaluate if it is safe to use tissue plasminogen activator tPA within 6 hours of stroke onset when combined with hypothermia
Detailed Description:
A stroke is usually caused by a blockage in one of the arteries that carries blood to the brain Research has shown that tissue plasminogen activator tPA-a naturally occurring protein that opens blocked arteries by dissolving blood clots-activates the bodys ability to dissolve recently formed blood clots and reduces or prevents the brain damage caused by a stroke
The Food and Drug Administration FDA has approved the use of tPA for people having a stroke when taken within 3 hours of stroke onset but not for those who arrive at the hospital more than 3 hours after stroke onset
Researchers believe that a lower body temperature hypothermia may be beneficial while a stroke is happening because hypothermia may prevent further brain injury or may make the stroke less damaging In particular hypothermia may make it possible to use tPA later than 3 hours after a stroke begins This study will determine if it is safe to use tPA within 6 hours of the start of a stroke when combined with hypothermia
Patients will receive a standard stroke evaluation which includes blood tests a computed tomography CT scan complete physical and neurological examinations and an electrocardiogram EKG to determine eligibility for the study
Participants will be randomly assigned to a study group based on when their stroke began Those who arrive at the hospital less than 3 hours from stroke onset will receive tPA alone or tPA with cooling hypothermia Those who arrive at the hospital 3 to 6 hours after stroke onset will be assigned to 1 of 4 groups-receiving either tPA alone tPA with cooling cooling alone or standard medical care Length of participation including observation after the patient leaves the hospital is 90 days
This study is part of the Specialized Program of Translational Research in Acute Stroke SPOTRIAS which allows researchers to enhance and initiate translational research that ultimately will benefit stroke patients by treating more patients in less than 2 hours and finding ways to treat additional patients later
The Food and Drug Administration FDA has approved the use of tPA for people having a stroke when taken within 3 hours of stroke onset but not for those who arrive at the hospital more than 3 hours after stroke onset
Researchers believe that a lower body temperature hypothermia may be beneficial while a stroke is happening because hypothermia may prevent further brain injury or may make the stroke less damaging In particular hypothermia may make it possible to use tPA later than 3 hours after a stroke begins This study will determine if it is safe to use tPA within 6 hours of the start of a stroke when combined with hypothermia
Patients will receive a standard stroke evaluation which includes blood tests a computed tomography CT scan complete physical and neurological examinations and an electrocardiogram EKG to determine eligibility for the study
Participants will be randomly assigned to a study group based on when their stroke began Those who arrive at the hospital less than 3 hours from stroke onset will receive tPA alone or tPA with cooling hypothermia Those who arrive at the hospital 3 to 6 hours after stroke onset will be assigned to 1 of 4 groups-receiving either tPA alone tPA with cooling cooling alone or standard medical care Length of participation including observation after the patient leaves the hospital is 90 days
This study is part of the Specialized Program of Translational Research in Acute Stroke SPOTRIAS which allows researchers to enhance and initiate translational research that ultimately will benefit stroke patients by treating more patients in less than 2 hours and finding ways to treat additional patients later
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None