Von Willebrand Factor Concentrate During ECMO Support
Acquired Von Willebrand Disease
About this trial
This is an interventional treatment trial for Acquired Von Willebrand Disease
Eligibility Criteria
Inclusion Criteria:
- Patients with the need of veno-arterial or veno-venous ECMO for a minimum of 48 hours
- Age ≥ 18 years
Exclusion Criteria:
- Patient with known thromboembolic event in the last 30 days
- Inevitable lethal course
- Severe Liver failure: Quick < 30 %
- Pregnancy
- Patient with known refusal of a participation in this clinical trial
- Active participation in another clinical trial
- Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study or confound the ability to interpret data from the study
Sites / Locations
- Medical University Innsbruck / Department for Anesthesia and Intensive Care Medicine
- Medical University Innsbruck / Department for General and Surgical Critical Care Medicine
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Group W (von Willebrand factor concentrate)
Group S (standard therapy with saline solution)
The patient receives von Willebrand factor concentrate (vWFC) as a bolus of 25 IU/kg followed by a continuous infusion of 50 IU/kg/24h until the weaning from ECMO is completed or if ECMO is needed longer than 7 days, the administration of the Investigational Medicinal Product (IMP) will be stopped on the 7th day.
The patient receives the standard therapy plus an additional volume of saline solution equivalent to the amount of von Willebrand factor concentrate (vWFC) the patient would receive in Group W to keep the blind. The volume is given according to the VWFC-solution (0.25 ml/kg BW) what would be resulting from the patient's weight followed by a continuous saline infusion (0.50 ml/kg BW) until the weaning from ECMO is completed or if ECMO is needed longer than 7 days, the Investigational Medicinal Product (IMP) administration is stopped on the 7th day.