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
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
Platelet aggregation response over time during venovenous ECMO at baseline — 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).
Platelet aggregation response over time during venovenous ECMO at Day 2 of ECMO — 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).
Platelet aggregation response over time during venovenous ECMO at Day 5 of ECMO — 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).
Platelet aggregation response over time during venovenous ECMO at Day 8 of ECMO — 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).
Trial sites (1)
Facility
City
Region
Status
UHToulouse
Toulouse
France
More University Hospital, Toulouse trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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