Frequency of Hemorrhages Associated With the Functional Anomalies of Willebrand Factor in Emergency Patients (WITECMO-H)

Study of the Frequency of Hemorrhages Associated With the Functional Anomalies of Willebrand Factor in Emergency Patients of a Veino Arterial or Veinous ECMO

ECMO has improved the outcome of heart or respiratory failure and carcinogenic shock and are increasingly used. However bleeding complications occurring in up to 50% of patients are poorly understood and worsen the overall results. The aim is to investigate the occurence of bleeding and its frequency according to the type of ECMO either veno-arterial or veno-venous. The investigators also want to assess the relation of bleeding with von Willebrand Factor defects.

Study Overview

• Status: Completed
• Conditions: Von Willebrand Diseases

• Study Type: Observational
• Enrollment (Actual): 257

Contacts and Locations

Study Locations

• France
  • Arras, France
    • CH Arras
  • Boulogne-sur-Mer, France
    • CH Boulogne
  • Douai, France
    • CH DOUAI
  • Dunkirk, France, 59385
    • Ch Dunkerque
  • Lille, France
    • Hôpital Cardiologie, CHU
  • Tourcoing, France
    • CH Tourcoing
  • Valenciennes, France
    • Ch Valenciennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients older than 18 years receiving either veno-arterial or even-venous ECMO and referred at Lille University Hospital

Description

Inclusion Criteria:

• informed consent of patient or person in charge
• patient supplied by an ECMO for cardiac or respiratory failure and referred to Lille University Hospital
• patient affiliated to "french social security"

Exclusion Criteria:

• pregnant woman
• no consent
• no affiliation to
• patient affiliated to '
• preexisting bleeding disorders

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of major bleeding	Number of major bleeding events (BARC classification ) occurring within the time course of support by ECMO	During ECMO support, up to 3 weeks after implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Abnormal VWF functional activities and multimeric profile according to the type of ECMO support (VA- or VV-ECMO)	Willebrand Factor abnormalities according to the type of ECMO support (VA- or VV-ECMO)	1 hour, 24 hours and day seven after implantation
Number of Participants With Abnormal VWF functional activities and multimeric profile before and after the first reduction in VA-ECMO flow rate	Willebrand Factor abnormalities according to residual arterial pulsatility levels under VA-ECMO	During ECMO support, up to 3 weeks after implantation
Number of Participants With Abnormal VWF functional activities and multimeric profile in 2 groups defined by the level of pulse pressure measured before ECMO weaning: high (> median) or low (< median) pulse pressure	Willebrand Factor abnormalities according to residual arterial pulsatility levels under VA-ECMO	During ECMO support, up to 3 weeks after implantation
Number of Participants With major bleeding events (BARC classification) before and after the first reduction in VA-ECMO flow rate	Willebrand Factor abnormalities according major bleeding events under VA-ECMO	During ECMO support, up to 3 weeks after implantation
Number of Participants With major bleeding events (BARC classification) in 2 groups defined by the level of pulse pressure measured before ECMO weaning: high (> median) or low (< median) pulse pressure	Willebrand Factor abnormalities according major bleeding events under VA-ECMO	During ECMO support, up to 3 weeks after implantation
Frequency of major bleeding events according to diabetes status	Number of major bleeding events (BARC classification ) occurring within the time course of support by ECMO in patients with and without diabetes	During ECMO support, up to 3 weeks after implantation
Frequency of major thrombotic events according to diabetes status	Number of major thrombotic events (stroke, transient ischemic attack, acute limb ischemia, ECMO thrombosis) occurring within the time course of support by ECMO in patients with and without diabetes	During ECMO support, up to 3 weeks after implantation
Frequency of pro-thrombotic biological abnormalities	Measurement of plasma free hemoglobin, leuco-platelet aggregates and neutrophil extracellular traps levels	During ECMO support, up to 3 weeks after implantation

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Antoine Rauch, MD,PhD, University Hospital, Lille

Publications and helpful links

General Publications

• Moussa MD, Abou-Arab O, Staessens S, Jungling M, Labreuche J, Lamer A, Beyls C, Rousse N, Rauch A, Loobuyck V, Beaudeux C, Pierache A, Deblauwe D, Corseaux D, Dubernet M, Guilbart M, Thellier L, Mahjoub Y, Juthier F, Dupont H, De Meyer SF, Vincentelli A, Susen S, Robin E. Comparison of the effects of phosphorylcholin versus heparin-based surface coating on clinical and histologic outcomes during veno-arterial extracorporeal membrane oxygenation support: a propensity score weighted analysis. J Thromb Haemost. 2025 Jun;23(6):1879-1892. doi: 10.1016/j.jtha.2025.02.020. Epub 2025 Feb 26.
• Rauch A, Dupont A, Rosa M, Desvages M, Le Tanno C, Abdoul J, Didelot M, Ung A, Ruez R, Jeanpierre E, Daniel M, Corseaux D, Spillemaeker H, Labreuche J, Pradines B, Rousse N, Lenting PJ, Moussa MD, Vincentelli A, Bordet JC, Staels B, Vincent F, Denis CV, Van Belle E, Casari C, Susen S. Shear Forces Induced Platelet Clearance Is a New Mechanism of Thrombocytopenia. Circ Res. 2023 Oct 27;133(10):826-841. doi: 10.1161/CIRCRESAHA.123.322752. Epub 2023 Oct 26.

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2018
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: February 28, 2017
• First Posted (Actual): March 6, 2017

Study Record Updates

• Last Update Posted (Estimated): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 22, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: mechanical circulatory support; bleeding, acquired von willebrand disease; acquired von willebrand disease
• Additional Relevant MeSH Terms: Pathologic Processes; Genetic Diseases, Inborn; Hematologic Diseases; Blood Coagulation Disorders; Hemorrhagic Disorders; Blood Platelet Disorders; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Hemorrhage; von Willebrand Diseases
• Other Study ID Numbers: 2015_83; 2017-A00256-47 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No