Platelets and Extracorporeal Membrane Oxygenation Veno-venous

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • blood draws

    Other intervention

    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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: patients on Extracorporeal Membrane Oxygenation veno-venous1 intervention

Trial outcomes

Primary outcomes

1

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)
2

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
3

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
4

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

Secondary outcomes

1

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
2

Platelet activation marker

Concentrations of platelet activation markers

Time frame
day 8
3

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
4

Leukocyte-platelet aggregate percentage

Percentage of leukocyte-platelet aggregates with leukocyte and platelet fluorescent labeling (flow cytometry)

Time frame
day 8

Other outcomes

Sponsors and contacts

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