Frequency of Hemorrhages Associated With the Functional Anomalies of Willebrand Factor in Emergency Patients
- 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
- 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"
- 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
CH ARRAS🇫🇷Arras, FranceMaxime GRANIER, MDPrincipal Investigator