Frequency of Hemorrhages Associated With the Functional Anomalies of Willebrand Factor in Emergency Patients

NCT03070912 | Completed

• 2 other identifiers: 2015_832017-A00256-47
• Study Type: observational
• Target: 257
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Von Willebrand Diseases

Keywords

mechanical circulatory support; bleeding, acquired von willebrand disease; acquired von willebrand disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Number of Participants With Abnormal VWF functional activities and multimeric profile 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

  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

  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

  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

  During ECMO support, up to 3 weeks after implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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"

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (7)

CH ARRAS

Arras, France

Location

CH Boulogne

Boulogne-sur-Mer, France

Location

CH DOUAI

Douai, France

Location

CH Dunkerque

Dunkirk, 59385, France

Location

Hôpital Cardiologie, CHU

Lille, France

Location

Ch Tourcoing

Tourcoing, France

Location

Ch Valenciennes

Valenciennes, France

Location

Related Publications (2)

• 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.

  PMID: 40020783 BACKGROUND

• 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.

  PMID: 37883587 RESULT

MeSH Terms

Conditions

von Willebrand Diseases; Hemorrhage

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Blood Platelet Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antoine RAUCH, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: March 6, 2017
• Study Start: January 19, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)