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

Study Overview
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Brief Summary
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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.

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

Conditions
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Von Willebrand Diseases

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mechanical circulatory support, bleeding, acquired von willebrand disease, acquired von willebrand disease