An observational study in Extracorporeal Membrane Oxygenation Complication, Hemorrhage and Blood Platelet Disorder, sponsored by University Hospital, Toulouse. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by University Hospital, Toulouse · Observational
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.
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.
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.
Exclusion Criteria:
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
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: T3: Day 8 of ECMO
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
Time frame: Up to Day 10 of ECMO
Platelet activation marker
Concentrations of platelet activation markers
Time frame: 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)
Time frame: day 8
Leukocyte-platelet aggregate percentage
Percentage of leukocyte-platelet aggregates with leukocyte and platelet fluorescent labeling (flow cytometry)
Time frame: day 8
Systemic anticoagulation level (anti-Xa activity)
The level of systemic anticoagulation will be assessed by anti-Xa activity (IU/mL)
Time frame: day 8
Markers of inflammation-leukocyte
Serum concentrations of inflammatory markers including leukocyte count (/mm³)
Time frame: day 8
Markers of inflammation- CRP
Serum concentrations of inflammatory markers including C-reactive protein (CRP, mg/L)
Time frame: day 8
Markers of inflammation_fibrinogen
Serum concentrations of inflammatory markers including fibrinogen (g/L)
Time frame: day 8
Platelet activation and aggregation parameters
Platelet activation marker concentrations and platelet aggregation intensity percentage, including platelet-leukocyte aggregation percentage
Time frame: Day 8
Hemolysis parameters-LDH
Serum levels of lactate dehydrogenase (LDH, IU/L)
Time frame: day 8
Hemolysis parameters-free bilirubin
Serum levels of and free bilirubin (µmol/L)
Time frame: day 8
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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University Hospital, Toulouse