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

University Hospital, Lille257 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

257

Conditions

Von Willebrand Diseases

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

CH ARRAS

Arras, France

CH Boulogne

Boulogne-sur-Mer, France

CH DOUAI

Douai, France

CH Dunkerque

Dunkirk, France

Hôpital Cardiologie, CHU

Outcomes

Primary Outcomes

Frequency of major bleeding

Number of major bleeding events (BARC classification ) occurring within the time course of support by ECMO

Time frame: During ECMO support, up to 3 weeks after implantation

Secondary Outcomes

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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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