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Not yet recruiting NCT07039513

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood sampling collection.
Who it may be relevant to
Registry conditions: ECMO, Mplementation of a Veno-venous VV or Veno-arterial VA, INTENSIVE CARE. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

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

Primary outcome measures

  • 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 [Time frame: 1 month]
Secondary outcome measures (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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 1 month]
  • To estimate the incidence of bleeding and thrombotic complications on ECMO on day 10 [Time frame: 1 month]
  • To estimate the incidence of bleeding and thrombotic complications on ECMO on day 10 [Time frame: 1 month]

Eligibility criteria

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

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
  • Service de Médecine Intensive - Réanimation Nouvel Hôpital Civil — Strasbourg

Identifiers

NCT: NCT07039513 · 9557 · 2024-A02754-43

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗