Platelets and Extracorporeal Membrane Oxygenation Veno-venous

Official title

Study of PLATelet Functions and Risk Factors for Hemorrhagic Complications in Patients on Extracorporeal Membrane Oxygenation Veno-venous: Prospective Monocentric Cohort

Overview

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.

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.

Interventions

• 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

Primary outcome measures

• Platelet aggregation response over time during venovenous ECMO at baseline [Time frame: T0: Baseline (before ECMO initiation)]
• Platelet aggregation response over time during venovenous ECMO at Day 2 of ECMO [Time frame: T1: Day 2 of ECMO]
• Platelet aggregation response over time during venovenous ECMO at Day 5 of ECMO [Time frame: T2: Day 5 of ECMO]
• Platelet aggregation response over time during venovenous ECMO at Day 8 of ECMO [Time frame: T3: Day 8 of ECMO]

Secondary outcome measures (11)

• Number of bleeding event [Time frame: Up to Day 10 of ECMO]
• Platelet activation marker [Time frame: day 8]
• Platelet aggregation intensity [Time frame: day 8]
• Leukocyte-platelet aggregate percentage [Time frame: day 8]
• Systemic anticoagulation level (anti-Xa activity) [Time frame: day 8]
• Markers of inflammation-leukocyte [Time frame: day 8]
• Markers of inflammation- CRP [Time frame: day 8]
• Markers of inflammation_fibrinogen [Time frame: day 8]
• Platelet activation and aggregation parameters [Time frame: Day 8]
• Hemolysis parameters-LDH [Time frame: day 8]
• Hemolysis parameters-free bilirubin [Time frame: day 8]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 1 center

• UHToulouse — Toulouse

Identifiers

NCT: NCT07580469 · RC31/25/0617

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗