Intravenous Thrombolysis Plus Hypothermia for Acute Treatment of Ischemic Stroke
Phase 1 Study of Intravenous Thrombolysis Plus Hypothermia for Acute Treatment of Ischemic Stroke
연구 개요
상세 설명
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 body's 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.
연구 유형
등록 (예상)
단계
- 1단계
연락처 및 위치
연구 장소
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California
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Palo Alto, California, 미국, 94304
- Stanford Medical Center
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San Diego, California, 미국, 92103
- Scripps Mercy Hospital
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San Diego, California, 미국, 92037
- University of California San Diego, Thornton Hospital
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San Diego, California, 미국, 92103
- University of California San Diego, Hillcrest Medical Center
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Connecticut
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Hartford, Connecticut, 미국, 06102
- Hartford Hospital
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Missouri
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St. Louis, Missouri, 미국, 63110
- Saint Louis University Medical Center
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Texas
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Houston, Texas, 미국, 77030
- Herman Memorial Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age 18 to 80
- 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:
- Etiology other than ischemic stroke
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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.
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tPA is a naturally occurring protein that opens blocked arteries by dissolving blood clots
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활성 비교기: 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.
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tPA is a naturally occurring protein that opens blocked arteries by dissolving blood clots
Hypothermia with or without tPA for stroke. Hypothermia is induced using the Celsius Control™ System. Subjects are stratified by time to six groups. |
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간섭 없음: 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).
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활성 비교기: 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).
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tPA is a naturally occurring protein that opens blocked arteries by dissolving blood clots
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활성 비교기: 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).
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Hypothermia with or without tPA for stroke. Hypothermia is induced using the Celsius Control™ System. Subjects are stratified by time to six groups. |
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활성 비교기: 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).
|
tPA is a naturally occurring protein that opens blocked arteries by dissolving blood clots
Hypothermia with or without tPA for stroke. Hypothermia is induced using the Celsius Control™ System. Subjects are stratified by time to six groups. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Incidence and volume of hemorrhage on CT
기간: 48 hours post onset
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48 hours post onset
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Incidence of AE and SAE
기간: 90 days post onset
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90 days post onset
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Mortality in both groups testing whether hypothermia improves mortality after stroke
기간: 90 Day
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90 Day
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NIHSS at the end of hypothermia
기간: Hour 23.5 +/- 30 minutes of hypothermia
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Hour 23.5 +/- 30 minutes of hypothermia
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Modified Rankin and NIHSS
기간: 30 and 90days
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30 and 90days
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CT lesion volume
기간: 30 days
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30 days
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공동 작업자 및 조사자
수사관
- 수석 연구원: Patrick Lyden, MD, University of California San Diego, Stroke Center
간행물 및 유용한 링크
일반 간행물
- 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.
- 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, Lyden PD. Induced hypothermia for acute stroke. Stroke. 2007 Feb;38(2 Suppl):794-9. doi: 10.1161/01.STR.0000247920.15708.fa.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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