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Platelets and Extracorporeal Membrane Oxygenation Veno-venous (PLAT-VV-ECMO)

2026年6月24日 更新者: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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (估计的)

40

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Toulouse、法国
        • UHToulouse
        • 接触:
          • baptiste compagnon, PH

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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.

描述

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)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Platelet aggregation response over time during venovenous ECMO at baseline
大体时间: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
大体时间: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
大体时间: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
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Number of bleeding event
大体时间: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
大体时间:day 8
Concentrations of platelet activation markers
day 8
Platelet aggregation intensity
大体时间: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
大体时间:day 8
Percentage of leukocyte-platelet aggregates with leukocyte and platelet fluorescent labeling (flow cytometry)
day 8
Systemic anticoagulation level (anti-Xa activity)
大体时间:day 8
The level of systemic anticoagulation will be assessed by anti-Xa activity (IU/mL)
day 8
Markers of inflammation-leukocyte
大体时间:day 8
Serum concentrations of inflammatory markers including leukocyte count (/mm³)
day 8
Markers of inflammation- CRP
大体时间:day 8
Serum concentrations of inflammatory markers including C-reactive protein (CRP, mg/L)
day 8
Markers of inflammation_fibrinogen
大体时间:day 8
Serum concentrations of inflammatory markers including fibrinogen (g/L)
day 8
Platelet activation and aggregation parameters
大体时间:Day 8
Platelet activation marker concentrations and platelet aggregation intensity percentage, including platelet-leukocyte aggregation percentage
Day 8
Hemolysis parameters-LDH
大体时间:day 8
Serum levels of lactate dehydrogenase (LDH, IU/L)
day 8
Hemolysis parameters-free bilirubin
大体时间:day 8
Serum levels of and free bilirubin (µmol/L)
day 8

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2028年12月31日

研究完成 (估计的)

2028年12月31日

研究注册日期

首次提交

2026年4月27日

首先提交符合 QC 标准的

2026年5月6日

首次发布 (实际的)

2026年5月12日

研究记录更新

最后更新发布 (实际的)

2026年6月29日

上次提交的符合 QC 标准的更新

2026年6月24日

最后验证

2026年6月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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