Von Willebrand Diseases
Conditions
Keywords
mechanical circulatory support, bleeding, acquired von willebrand disease, acquired von willebrand disease
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.
Interventions
None listed
Sponsors
University Hospital, Lille
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 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) |
| 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 |
| 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 |
| 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 |
Countries
France
Outcome results
None listed