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

Von Willebrand Diseases Clinical Trial

— WITECMO-H  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03070912
• Other study ID #: 2015_83
• Secondary ID: 2017-A00256-47
• Status: Recruiting
• Start date: January 19, 2018
• Est. completion date: May 2026

Study information

• Verified date: February 2023
• Source: University Hospital, Lille
• Contact: Antoine RAUCH, MD,PhD
• Phone: 320445962 (poste 29673)
• Email: antoine.rauch[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 418
• Est. completion date: May 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Hemorrhage
• Von Willebrand Diseases

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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