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

Recruiting

• Conditions: Von Willebrand Diseases

• Registration Number: NCT03070912
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-13
• Study First Submitted QC: 2017-02-28
• Study First Posted: 2017-03-06
• Study Start: 2018-01-19
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-06
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 418

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	Willebrand Factor abnormalities according to the type of ECMO support (VA- or VV-ECMO)
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	Willebrand Factor abnormalities according to residual arterial pulsatility levels under VA-ECMO
Frequency of major bleeding events according to diabetes status	During ECMO support, up to 3 weeks after implantation	Number of major bleeding events (BARC classification ) occurring within the time course of support by ECMO in patients with and without diabetes
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	Willebrand Factor abnormalities according to residual arterial pulsatility levels under VA-ECMO
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	Willebrand Factor abnormalities according major bleeding events under VA-ECMO
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	Willebrand Factor abnormalities according major bleeding events under VA-ECMO
Frequency of major thrombotic events according to diabetes status	During ECMO support, up to 3 weeks after implantation	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
Frequency of pro-thrombotic biological abnormalities	During ECMO support, up to 3 weeks after implantation	Measurement of plasma free hemoglobin, leuco-platelet aggregates and neutrophil extracellular traps levels

Trial Locations

Locations (7)

CH ARRAS; 🇫🇷 Arras, France

CH Boulogne; 🇫🇷 Boulogne-sur-Mer, France

CH DOUAI; 🇫🇷 Douai, France

CH Dunkerque; 🇫🇷 Dunkerque, France

Hôpital Cardiologie, CHU; 🇫🇷 Lille, France

Ch Tourcoing; 🇫🇷 Tourcoing, France

Ch Valenciennes; 🇫🇷 Valenciennes, France