Platelets and Extracorporeal Membrane Oxygenation Veno-venous (PLAT-VV-ECMO)
2026년 5월 6일 업데이트: University Hospital, Toulouse
Study of PLATelet Functions and Risk Factors for Hemorrhagic Complications in Patients on Extracorporeal Membrane Oxygenation Veno-venous: Prospective Monocentric Cohort
In severe lung or heart disease, ExtraCorporeal Membrane Oxygenation (ECMO) may be used temporarily and can be responsible for major haemorrhagic complications.
Thrombocytopenia and possibly thrombopathy promote bleeding.
The primary objective is to characterize platelet dysfunction by aggregometry tests over time.
Secondarily, investigators seek a correlation between haemorrhagic complications at day 10 and markers of platelet action and dysfunction; also, with the level of anticoagulation and inflammation by biomarkers.
연구 개요
상세 설명
Despite the frequency of thrombocytopenia in patients on VV-ECMO and its associated haemorrhagic consequences, its predictive factors are still poorly described.
Furthermore, studies suggest the presence of thrombopathy in patients on ECMO, but they are scarce and based on a heterogeneous population with a small sample size, or with vent-arterial (VA) ECMO, mainly after cardiac surgery exposed to a different extracorporeal circulation.
The factors responsible for this thrombopathy and its repercussions are currently unknown.
In contrast to previous studies that focused on platelet functions in patients on ECMO, our study will be the first to analyse specialized platelet functions and thrombo-inflammation in a cohort only with VV-ECMO excluding cardiac surgery patients at risk of thrombopathy.
This work will provide, for the first time, a comprehensive view of the patient on VV-ECMO, ranging from clinical characteristics to the study of platelet activation and functions and thrombo-inflammation analysis and also integrating biological data and ECMO characteristics, all over time.
The procedure will involve collecting blood samples from the patient on VV-ECMO and platelet aggregation tests will be performed, along with measurements of platelet activation markers and a search for leuko-platelet aggregates.
Investigators will evaluate the clinical-biological impact by searching for blood hemolysis, the level of inflammation, coagulopathy and hemorrhagic complications during VV-ECMO support.
The patient's clinical characteristics will be analysed until their discharge from the intensive care unit.
Clinical, biological, ECMO, and specialized haemostasis data will be studied to achieve the study objectives.
연구 유형
관찰
등록 (추정된)
40
연락처 및 위치
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연구 연락처
- 이름: Baptiste COMPAGNON
- 전화번호: +33 5 61 32 27 99
- 이메일: compagnon.b@chu-toulouse.fr
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
The study population will be selected from adult patients requiring venovenous ECMO support and admitted to the general intensive care unit of Hôpital Rangueil (Toulouse University Hospital), a regional referral center for ECMO in Occitanie West.
Patients may be transferred from other hospitals in the region or directly managed at Hôpital Rangueil following ECMO implantation.
설명
Inclusion Criteria:
- Adults aged ≥ 18 years
- No objection to participation in the study, obtained from a relative or trusted person; if no relative is available, inclusion under emergency procedure (pending patient or relative non-opposition)
- Patients requiring admission to the general intensive care unit of Hôpital Rangueil for venovenous ECMO
- Equipped with an arterial catheter for blood sampling
- Ability to undergo the 4 blood draws relevant to the study
- Receiving therapeutic anticoagulation with unfractionated heparin
- Enrolled in a social security program or equivalent
- No measures for Limitation and Withdrawal of Therapy have been implemented
Exclusion Criteria:
- Minors
- Patients under court-appointed guardianship or conservatorship
- Pregnant or breastfeeding women
- Hematological disease (leukemia, lymphoma) or constitutional thrombocytopenia
- Platelet transfusion within 7 days prior to enrollment
- Indication for immediate emergency ECMO preventing blood sampling before placement
- Post-cardiotomy
- Patient on antiplatelet therapy
- Severe thrombocytopenia <50 G/L
- Other invasive mechanical support such as Impella®, intra-aortic balloon pump, or Left Ventricular Assist Device (LVAD)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
patients on Extracorporeal Membrane Oxygenation veno-venous
major patients admitted to the general intensive care unit on Extracorporeal Membrane Oxygenation veno-venous
|
Part of the biology data is used from the patient's routine blood tests.
Additional blood samples are taken from an arterial catheter already in place.
They are performed over 4 periods: one just before start ECMO and 3 under ECMO at 3-day intervals
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Platelet aggregation response over time during venovenous ECMO at baseline
기간: T0: Baseline (before ECMO initiation)
|
Platelet aggregation level (expressed as percentage intensity) during venovenous ECMO following stimulation with three platelet agonists (TRAP, CRP, and ADP).
|
T0: Baseline (before ECMO initiation)
|
|
Platelet aggregation response over time during venovenous ECMO at Day 2 of ECMO
기간: T1: Day 2 of ECMO
|
Platelet aggregation level (expressed as percentage intensity) during venovenous ECMO following stimulation with three platelet agonists (TRAP, CRP, and ADP).
|
T1: Day 2 of ECMO
|
|
Platelet aggregation response over time during venovenous ECMO at Day 5 of ECMO
기간: T2: Day 5 of ECMO
|
Platelet aggregation level (expressed as percentage intensity) during venovenous ECMO following stimulation with three platelet agonists (TRAP, CRP, and ADP).
|
T2: Day 5 of ECMO
|
|
Platelet aggregation response over time during venovenous ECMO at Day 8 of ECMO
기간: T3: Day 8 of ECMO
|
Platelet aggregation level (expressed as percentage intensity) during venovenous ECMO following stimulation with three platelet agonists (TRAP, CRP, and ADP).
|
T3: Day 8 of ECMO
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of bleeding event
기간: Up to Day 10 of ECMO
|
Numbers of Bleeding event occurring within the first 10 days of VV-ECMO: internal and/or external bleeding that, due to its severity, requires discontinuation of anticoagulation and/or a blood transfusion and/or a surgical or interventional procedure and/or results in a life-threatening condition
|
Up to Day 10 of ECMO
|
|
Platelet activation marker
기간: day 8
|
Concentrations of platelet activation markers
|
day 8
|
|
Platelet aggregation intensity
기간: day 8
|
Percentage of platelet aggregation intensity measured at the four sampling time points and following stimulation with three platelet agonists (TRAP, CRP, and ADP)
|
day 8
|
|
Leukocyte-platelet aggregate percentage
기간: day 8
|
Percentage of leukocyte-platelet aggregates with leukocyte and platelet fluorescent labeling (flow cytometry)
|
day 8
|
|
Systemic anticoagulation level (anti-Xa activity)
기간: day 8
|
The level of systemic anticoagulation will be assessed by anti-Xa activity (IU/mL)
|
day 8
|
|
Markers of inflammation-leukocyte
기간: day 8
|
Serum concentrations of inflammatory markers including leukocyte count (/mm³)
|
day 8
|
|
Markers of inflammation- CRP
기간: day 8
|
Serum concentrations of inflammatory markers including C-reactive protein (CRP, mg/L)
|
day 8
|
|
Markers of inflammation_fibrinogen
기간: day 8
|
Serum concentrations of inflammatory markers including fibrinogen (g/L)
|
day 8
|
|
Platelet activation and aggregation parameters
기간: Day 8
|
Platelet activation marker concentrations and platelet aggregation intensity percentage, including platelet-leukocyte aggregation percentage
|
Day 8
|
|
Hemolysis parameters-LDH
기간: day 8
|
Serum levels of lactate dehydrogenase (LDH, IU/L)
|
day 8
|
|
Hemolysis parameters-free bilirubin
기간: day 8
|
Serum levels of and free bilirubin (µmol/L)
|
day 8
|
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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 5월 1일
기본 완료 (추정된)
2028년 12월 31일
연구 완료 (추정된)
2028년 12월 31일
연구 등록 날짜
최초 제출
2026년 4월 27일
QC 기준을 충족하는 최초 제출
2026년 5월 6일
처음 게시됨 (실제)
2026년 5월 12일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 12일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 6일
마지막으로 확인됨
2026년 5월 1일
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