ECMO, INTENSIVE CARE, Mplementation of a Veno-venous VV or Veno-arterial VA
Conditions
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.
Interventions
Collection of an additional of 2.7mL citrate tube of blood for a D-dimer dosage.
Sponsors
University Hospital, Strasbourg, France
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Sensitivity (Se) |
| To estimate the incidence of bleeding and thrombotic complications on ECMO on day 10 | 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, |
Countries
France
Contacts
Primary ContactJulie HELMS, Professor
Outcome results
None listed