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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemorrhage; Thrombosis; Extracorporeal Membrane Oxygenation Complication; Blood Platelet Disorder
• Intervention / Treatment: Other: blood draws

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Baptiste COMPAGNON; Phone Number: +33 5 61 32 27 99; Email: compagnon.b@chu-toulouse.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients on Extracorporeal Membrane Oxygenation veno-venous; major patients admitted to the general intensive care unit on Extracorporeal Membrane Oxygenation veno-venous	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet aggregation response over time during venovenous ECMO at baseline	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	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	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	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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 12, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Platelets; Thrombopathy; thrombo-inflammation; VV-ECMO; thrombo-haemorrhagic complications
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Hematologic Diseases; Embolism and Thrombosis; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Thrombosis; Hemorrhage; Blood Platelet Disorders; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: RC31/25/0617