Intravenous Thrombolysis Plus Hypothermia for Acute Treatment of Ischemic Stroke
NCT ID: NCT00283088
Last Updated: 2011-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
130 participants
INTERVENTIONAL
2003-10-31
2009-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Intravascular Cooling in the Treatment of Stroke 2/3 Trial
NCT01123161
Safety of Intravenous Thrombolytics in Stroke on Awakening
NCT01643902
Safety of Intravenous Thrombolysis for Wake-up Stroke
NCT01183533
Efficacy and Safety of Tenecteplase Intravenous Thrombolysis in Acute Posterior Circulation Ischemic Stroke Within 4.5-24 Hours After Onset
NCT07094763
Safety Study of Post Intravenous tPA Monitoring in Ischemic Stroke
NCT02039375
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
Groups 1 and 2: Parallel groups, randomized to hypothermia or no hypothermia. Both groups receive tPA as a part of standard of care.
tissue plasminogen activator
tPA is a naturally occurring protein that opens blocked arteries by dissolving blood clots
Group 2
Groups 1 and 2: Parallel groups, randomized to hypothermia or no hypothermia. Both groups receive tPA as a part of standard of care.
hypothermia
Hypothermia with or without tPA for stroke. Hypothermia is induced using the Celsius Control™ System.
Subjects are stratified by time to six groups.
tissue plasminogen activator
tPA is a naturally occurring protein that opens blocked arteries by dissolving blood clots
Group 3
Groups 3, 4, 5 and 6: Factorial groups, randomized to hypothermia plus tPA, hypothermia alone, tPA alone, or no treatment assignment (standard of care).
No interventions assigned to this group
Group 4
Groups 3, 4, 5 and 6: Factorial groups, randomized to hypothermia plus tPA, hypothermia alone, tPA alone, or no treatment assignment (standard of care).
tissue plasminogen activator
tPA is a naturally occurring protein that opens blocked arteries by dissolving blood clots
Group 5
Groups 3, 4, 5 and 6: Factorial groups, randomized to hypothermia plus tPA, hypothermia alone, tPA alone, or no treatment assignment (standard of care).
hypothermia
Hypothermia with or without tPA for stroke. Hypothermia is induced using the Celsius Control™ System.
Subjects are stratified by time to six groups.
Group 6
Groups 3, 4, 5 and 6: Factorial groups, randomized to hypothermia plus tPA, hypothermia alone, tPA alone, or no treatment assignment (standard of care).
hypothermia
Hypothermia with or without tPA for stroke. Hypothermia is induced using the Celsius Control™ System.
Subjects are stratified by time to six groups.
tissue plasminogen activator
tPA is a naturally occurring protein that opens blocked arteries by dissolving blood clots
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
hypothermia
Hypothermia with or without tPA for stroke. Hypothermia is induced using the Celsius Control™ System.
Subjects are stratified by time to six groups.
tissue plasminogen activator
tPA is a naturally occurring protein that opens blocked arteries by dissolving blood clots
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* All eligibility criteria for t-PA administration for acute ischemic stroke as outlined by the NINDS tPA Guidelines are met with the exception of time from onset
* Stroke onset within 6 hours prior to planned start of tPA
* Any subtype of ischemic stroke with NIHSS \< 7 at the time hypothermia begins
Exclusion Criteria
* Item 1a on NIHSS\>1 at the time of enrollment
* Symptoms resolving or NIHSS \< 7 at the time hypothermia begins
* Contraindications to hypothermia, such as patients with known hematologic dyscrasias which affect thrombosis, (cryoglobulinemia, Sickle cell disease, serum cold agglutinins), or vasospastic disorders such as Raynaud's or thromboangiitis obliterans.
* Known co-morbid conditions likely to complicate therapy, e.g., end-stage cardiomyopathy, uncompensated arrhythmia, myopathy, liver disease severe enough to elevate bilirubin, history of pelvic or abdominal mass likely to compress inferior vena cava, IVC filters, dementia severe enough to prevent valid consent, end-stage AIDS, known thyroid deficiency, known renal insufficiency likely to impair meperidine (Demerol®) clearance
* Intracerebral hematoma
* Any intraventricular hemorrhage
* SBP \> 185 or \< 100; DBP \> 110 or \< 50 mmHg
* Pregnancy in women of child-bearing potential (must have pregnancy test, urine or blood, prior to therapy).
* Medical conditions likely to interfere with patient assessment
* Known allergy to meperidine (Demerol®)
* Currently taking MAO-I class of medication or used within previous 14 days
* Life expectancy \< 3 months
* Not likely to be available for long-term follow-up.
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of California, San Diego
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
University of California San Diego, Stroke Center
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Patrick Lyden, MD
Role: PRINCIPAL_INVESTIGATOR
University of California San Diego, Stroke Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stanford Medical Center
Palo Alto, California, United States
University of California San Diego, Thornton Hospital
San Diego, California, United States
Scripps Mercy Hospital
San Diego, California, United States
University of California San Diego, Hillcrest Medical Center
San Diego, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Saint Louis University Medical Center
St Louis, Missouri, United States
Herman Memorial Hospital
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lyden PD, Allgren RL, Ng K, Akins P, Meyer B, Al-Sanani F, Lutsep H, Dobak J, Matsubara BS, Zivin J. Intravascular Cooling in the Treatment of Stroke (ICTuS): early clinical experience. J Stroke Cerebrovasc Dis. 2005 May-Jun;14(3):107-14. doi: 10.1016/j.jstrokecerebrovasdis.2005.01.001.
Guluma KZ, Hemmen TM, Olsen SE, Rapp KS, Lyden PD. A trial of therapeutic hypothermia via endovascular approach in awake patients with acute ischemic stroke: methodology. Acad Emerg Med. 2006 Aug;13(8):820-7. doi: 10.1197/j.aem.2006.03.559. Epub 2006 Jun 9.
Hemmen TM, Raman R, Guluma KZ, Meyer BC, Gomes JA, Cruz-Flores S, Wijman CA, Rapp KS, Grotta JC, Lyden PD; ICTuS-L Investigators. Intravenous thrombolysis plus hypothermia for acute treatment of ischemic stroke (ICTuS-L): final results. Stroke. 2010 Oct;41(10):2265-70. doi: 10.1161/STROKEAHA.110.592295. Epub 2010 Aug 19.
Hemmen TM, Lyden PD. Induced hypothermia for acute stroke. Stroke. 2007 Feb;38(2 Suppl):794-9. doi: 10.1161/01.STR.0000247920.15708.fa.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
P50NS44148LYDEN
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.