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

NCT07039513 | Not Yet Recruiting

• 2 other identifiers: 95572024-A02754-43
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  Difference in D-dimer over 24 hours associated with the occurrence of severe bleeding within 24 hours.

  1 month

Secondary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

Interventions

Blood sampling collection OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patient in intensive care with implementation of a VV or VA ECMO for less than 24 hours

You may qualify if:

• 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

You may not qualify if:

• 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
• Patient under judicial protection
• Patient under guardianship or curatorship
• Pregnancy
• Breastfeeding

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Médecine Intensive - Réanimation Nouvel Hôpital Civil

Strasbourg, 67098, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sampling collection

Central Study Contacts

Julie HELMS, Professor

CONTACT

+33369551369; julie.helms@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 26, 2025
• Study Start: November 27, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

FR (1)