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

NCT ID: NCT07039513

Last Updated: 2025-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-11-27

Study Completion Date

2027-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Blood sampling collection

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de Médecine Intensive - Réanimation Nouvel Hôpital Civil

Strasbourg, , France

Site Status

Countries

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France

Central Contacts

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Julie HELMS, Professor

Role: CONTACT

+33369551369

Other Identifiers

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9557

Identifier Type: -

Identifier Source: org_study_id

2024-A02754-43

Identifier Type: OTHER

Identifier Source: secondary_id

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