Ireland
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Starting soon Observational

EVOLUTION OF D-DIMER AS A MARKER OF BLEEDING RISK ON ECMO

NCT07039513 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-11-27
Last updated
2025-12-01

Condition(s) studied

ECMOMplementation of a Veno-venous VV or Veno-arterial VAINTENSIVE CARE

Investigational drug(s) / intervention(s)

Blood sampling collection

Blood sampling collection: Collection of an additional of 2.7mL citrate tube of blood for a D-dimer dosage.

Study summary

ECMO (extracorporeal membrane oxygenation) is a life-saving device, used in intensive care to treat severe respiratory or cardiac failure. However, it carries a high risk of serious life-threatening bleeding.

Bleeding complications have been attributed to coagulopathy triggered either by the underlying pathology or by the extracorporeal circuit itself, as well as excessive or inappropriate anticoagulation initiated to prevent thrombotic complications.

The objective of this cohort is to confirm the interest of the evolution of D-dimers as a prognostic marker of serious bleeding events in patients on veno-venous (VV) or veno-arterial (VA) ECMO, and to determine the threshold.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Male or female ≥ 18 years of age * Hospitalized patient in intensive care * Implementation of a VV or VA ECMO for less than 24 hours * Patient affiliated to a social protection health insurance scheme * Non-opposition by the patient or a relative in the event that the patient is not in a state to express his or her non-opposition or inclusion in an emergency procedure in the event that the patient is not in a state to express his or her non-opposition and no relative of the patient can be reached. Exclusion Criteria: * Patient on veno-arterial ECMO after cardiac, cardiopulmonary surgery or after placement of a left or biventricular cardiac assist device * Congenital hemostasis disorder or anatomical abnormality predisposing to bleeding * Dying patient on the day of inclusion * Patient under judicial protection * Patient under guardianship or curatorship * Pregnancy * Breastfeeding

Primary outcome measure(s)

  • To determine the most discriminating 24-hour D-Dimer increase threshold for predicting a serious bleeding event under ECMO within 24 hours of D-Dimer increase — 1 month
    Difference in D-dimer over 24 hours associated with the occurrence of severe bleeding within 24 hours.

Trial sites (1)

FacilityCityRegionStatus
Service de Médecine Intensive - Réanimation Nouvel Hôpital Civil Strasbourg France
Official registry record

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.

View NCT07039513 on ClinicalTrials.gov ↗ ← All trials in France