EVOLUTION OF D-DIMER AS A MARKER OF BLEEDING RISK ON ECMO | NCT07039513

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

NCT07039513

Sponsor

University Hospital, Strasbourg, France

Status

Not yet recruiting

Last Update Posted

Dec 1, 2025Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

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

Interventions

Blood sampling collection

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2024-A02754-43	Other Identifier	ANSM

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 27, 2025Estimated

Primary Completion Date

May 1, 2027Estimated

Completion Date

Jun 1, 2027Estimated

First Submitted Date

Jun 17, 2025

First Submission Date that Met QC Criteria

Jun 17, 2025

First Posted Date

Jun 26, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2025

Last Update Posted Date

Dec 1, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood sampling collection	Other	Collection of an additional of 2.7mL citrate tube of blood for a D-dimer dosage.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	1 month

Secondary Outcomes

Measure	Description	Time Frame
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)	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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Julie HELMS, Professor	Contact	+33369551369		julie.helms@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Médecine Intensive - Réanimation Nouvel Hôpital Civil		Strasbourg		67098	France