Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

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

6 de maio de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

40

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
patients on Extracorporeal Membrane Oxygenation veno-venous
major patients admitted to the general intensive care unit on Extracorporeal Membrane Oxygenation veno-venous
Outro: blood draws
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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Platelet aggregation response over time during venovenous ECMO at baseline
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Medidas de resultados secundários

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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University Hospital, Toulouse

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de maio de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2028

Conclusão do estudo (Estimado)

31 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

27 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de maio de 2026

Primeira postagem (Real)

12 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • RC31/25/0617

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em blood draws

Pesquisar ensaios semelhantes

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

CROs by country

CROs in Portugal

Condições

Doenças Raras

Intervenções de drogas

Suplementos Alimentares

Patrocinador / Colaboradores

Localizações

Se inscrever