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NCT Number: NCT07039513

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

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.

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Key information

Conditions

ECMO Intensive Care Mplementation of a Veno-venous VV or Veno-arterial VA

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Médecine Intensive - Réanimation Nouvel Hôpital Civil

Strasbourg, 67098, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling collection

Other

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

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

    Time frame: 1 month

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

Secondary outcomes

  1. 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

    Sensitivity (Se)

  2. 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

    Specificity (Spe)

  3. 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

    Positive Predictive Value (PPV)

  4. 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

    Negative Predictive Value (NPV)

  5. 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

    Positive and Negative Likelihood Ratios of 24-Hour D-Dimer Increase

  6. To estimate the incidence of bleeding and thrombotic complications on ECMO on day 10

    Time frame: 1 month

    Occurrence of hemorrhagic complications on ECMO on day 10:

    Bleeding events defined by BARC classification, type of bleeding (arterial/venous) and location, transfusions of labile blood products (number/volume/type), other treatments (endoscopy with hemostatic procedure,

  7. To estimate the incidence of bleeding and thrombotic complications on ECMO on day 10

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Julie HELMS, Professor

CONTACT

[email protected]

+33369551369

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: ECMOstase2

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 26, 2025
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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