Health TrialsbyHealthPanel

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

ConditionsECMOMplementation of a Veno-venous VV or Veno-arterial VAINTENSIVE CARE
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood sampling collection

    Other intervention

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

Treatment groups

No treatment groups listed

Trial outcomes

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.

Time frame
1 month

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.

Sensitivity (Se)

Time frame
1 month
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.

Specificity (Spe)

Time frame
1 month
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.

Positive Predictive Value (PPV)

Time frame
1 month
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.

Negative Predictive Value (NPV)

Time frame
1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Strasbourg, France

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: