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- Ensayo clínico NCT07580469
Platelets and Extracorporeal Membrane Oxygenation Veno-venous (PLAT-VV-ECMO)
6 de mayo de 2026 actualizado 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
De observación
Inscripción (Estimado)
40
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Baptiste COMPAGNON
- Número de teléfono: +33 5 61 32 27 99
- Correo electrónico: compagnon.b@chu-toulouse.fr
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Platelet aggregation response over time during venovenous ECMO at baseline
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of bleeding event
Periodo de tiempo: 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
Periodo de tiempo: day 8
|
Concentrations of platelet activation markers
|
day 8
|
|
Platelet aggregation intensity
Periodo de tiempo: 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
Periodo de tiempo: day 8
|
Percentage of leukocyte-platelet aggregates with leukocyte and platelet fluorescent labeling (flow cytometry)
|
day 8
|
|
Systemic anticoagulation level (anti-Xa activity)
Periodo de tiempo: day 8
|
The level of systemic anticoagulation will be assessed by anti-Xa activity (IU/mL)
|
day 8
|
|
Markers of inflammation-leukocyte
Periodo de tiempo: day 8
|
Serum concentrations of inflammatory markers including leukocyte count (/mm³)
|
day 8
|
|
Markers of inflammation- CRP
Periodo de tiempo: day 8
|
Serum concentrations of inflammatory markers including C-reactive protein (CRP, mg/L)
|
day 8
|
|
Markers of inflammation_fibrinogen
Periodo de tiempo: day 8
|
Serum concentrations of inflammatory markers including fibrinogen (g/L)
|
day 8
|
|
Platelet activation and aggregation parameters
Periodo de tiempo: Day 8
|
Platelet activation marker concentrations and platelet aggregation intensity percentage, including platelet-leukocyte aggregation percentage
|
Day 8
|
|
Hemolysis parameters-LDH
Periodo de tiempo: day 8
|
Serum levels of lactate dehydrogenase (LDH, IU/L)
|
day 8
|
|
Hemolysis parameters-free bilirubin
Periodo de tiempo: day 8
|
Serum levels of and free bilirubin (µmol/L)
|
day 8
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de mayo de 2026
Finalización primaria (Estimado)
31 de diciembre de 2028
Finalización del estudio (Estimado)
31 de diciembre de 2028
Fechas de registro del estudio
Enviado por primera vez
27 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
6 de mayo de 2026
Publicado por primera vez (Actual)
12 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
6 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Procesos Patológicos
- Enfermedades hematológicas
- Embolia y Trombosis
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades hemic y linfáticas
- Trombosis
- Hemorragia
- Trastornos de las plaquetas sanguíneas
- Técnicas de investigación
- Manejo de muestras
- Técnicas de laboratorio clínico
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Puntas
- Procedimientos quirúrgicos, operativo
- Recolección de muestras de sangre
Otros números de identificación del estudio
- RC31/25/0617
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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