About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Minors
Patients under court-appointed guardianship or conservatorship
Pregnant or breastfeeding women
Hematological disease (leukemia, lymphoma) or constitutional thrombocytopenia
Trial 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.
Trial design
Cohort
Prospective
Treatments tested in this trial
blood draws
Other interventionPart 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
Treatment groups
Trial outcomes
Primary outcomes
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).
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).
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).
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).
Secondary outcomes
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
Platelet activation marker
Concentrations of platelet activation markers
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)
Leukocyte-platelet aggregate percentage
Percentage of leukocyte-platelet aggregates with leukocyte and platelet fluorescent labeling (flow cytometry)
Sponsors and contacts
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