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

Not yet recruiting

• Conditions: ECMO; Mplementation of a Veno-venous VV or Veno-arterial VA; INTENSIVE CARE

• Registration Number: NCT07039513
• Lead Sponsor: University Hospital, Strasbourg, France

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-17
• Study First Submitted QC: 2025-06-17
• Last Update Submitted: 2025-06-17
• Study First Posted: 2025-06-26
• Last Update Posted: 2025-06-26
• Study Start: 2025-07-01
• Primary Completion: 2027-01-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
To estimate the incidence of bleeding and thrombotic complications on ECMO on day 10	1 month	Occurrence of thrombotic complications on ECMO on day 10: Thrombotic and ischemic events: ischemic stroke, limb/extremity ischemia, acute coronary syndrome, ECMO circuit thrombosis
To estimate the predictive performance of the 24-hour increase in D-dimer in the occurrence of a serious bleeding event on ECMO within 24 hours.	1 month	Positive and Negative Likelihood Ratios of 24-Hour D-Dimer Increase

Trial Locations

Locations (1)

Service de Médecine Intensive - Réanimation Nouvel Hôpital Civil; 🇫🇷 Strasbourg, France