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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

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
NameTimeMethod
Frequency of major bleedingDuring 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
NameTimeMethod
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 pressureDuring 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 statusDuring 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 rateDuring 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 rateDuring 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 pressureDuring 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 statusDuring 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 abnormalitiesDuring 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

CH ARRAS
🇫🇷Arras, France
Maxime GRANIER, MD
Principal Investigator

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