- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02176993
Effects of Surface Cooling On Stroke Outcome triaL (COOL) (COOL)
Effects of Surface Cooling On Stroke Outcome triaL: a Feasibility and Safety Study
The investigators goal is to improve the outcome of patients with acute stroke by inducing mild cerebral hypothermia through surface cooling at the cervical and shoulder regions using EMCOOLS Brain.Pads®.
For this project, the investigators can build further on their research group's experience with hypothermia in animal models and invasive cooling in stroke patients.
The COOL program will prospectively evaluate safety, feasibility, patient acceptance and efficacy of mild cerebral hypothermia using EMCOOLS Brain.Pads® in a large cohort of patients presenting with acute stroke at the Emergency Department of the Universitair Ziekenhuis Brussel. The application of EMCOOLS Brain.Pads® will be compared to routine clinical practice in a randomized controlled trial. If proven to be safe, feasible, well-tolerated and efficacious in the inhospital setting, future use in prehospital acute stroke care will be incorporated with telemedicine support, as part of the Prehospital Stroke Study at the Universitair ziekenhuis Brussel (PreSSUB).
연구 개요
상세 설명
Several studies have identified fever as an independent predictor of poor outcome in patients with acute stroke. Experimental data and clinical studies indicate that therapeutic hypothermia has neuroprotective effects associated with better clinical outcome, probably through reduction of infarct volume and cerebral edema in patients with ischemic and hemorrhagic stroke, respectively. It is to be expected that the beneficiary effects of hypothermia will be more pronounced if initiated early after stroke onset, which underlines the rational that this technique ideally should be initiated in the prehospital phase of acute stroke management.
Therapeutic hypothermia can be obtained by external or by endovascular cooling. Most methods aim to lower the body temperature to <33°C and therefore require patient sedation and intubation. In contrast to patients with cardiac arrest, sedation and intubation preferably are avoided and profound cooling of the entire body is not desired nor required in in stroke patients. EMCOOLS pads® have originally been developed by EMCOOLS Medical Cooling Systems AG (Austria) for profound external cooling of patients with cardiac arrest. The novel EMCOOLS Brain.Pad® was redesigned to mildly lower the brain temperature through noninvasive surface cooling of the cerebropetal arteries at the cervical level. Pilot studies in healthy volunteers demonstrated that a decrease of 0.5-1°C (tympanic measurement) can be safely obtained by application of EMCOOLS Brain.Pad® during 60 to 90 minutes. No relevant side effects were observed in these small studies, but possible effects on cerebrovascular blood flow were not evaluated.
Early application of mild therapeutic hypothermia in acute stroke patients builds further on their research group's experience with hypothermia in animal models and stroke patients. The investigators propose a prospective clinical trial comparing current clinical practice with the induction of mild hypothermia using EMCOOLS Brain.Pads® in patients presenting with acute stroke. If safety, feasibility, patient acceptance and efficacy are confirmed in the inhospital setting, the next step will involve evaluation of this approach in prehospital acute stroke care.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Brussels, 벨기에, 1090
- Universitair Ziekenhuis Brussel
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Older than 18 years
- Acute stroke with onset < 24 hours
Exclusion Criteria:
- Pregnancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
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Application of surface cooling
Surface cooling during 60 minutes.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Improvement of neurological deficit as measured by NIHSS
기간: 90 days post-stroke
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The National Institute of Health Stroke Scale (NIHSS) will be used as a measure to assess the gain in neurological deficit 90 days post-stroke.
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90 days post-stroke
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Temperature change during surface cooling
기간: During cooling and 30 minutes thereafter
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Changes in temperature will be measured with mastoid, inguinal, tympanic and temporal thermometers.
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During cooling and 30 minutes thereafter
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Long-term functional outcome
기간: 3 months post-stroke
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The functional outcome will be measured by the modified Rankin Scale (mRS).
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3 months post-stroke
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Mortality rate
기간: 3 months post-stroke
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3 months post-stroke
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공동 작업자 및 조사자
수사관
- 수석 연구원: Robbert-Jan van Hooff, M.D., Ph.D., Universitair Ziekenhuis Brussel Belgium
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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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