About this trial
Adult patients on extracoporeal membrane oxygenation (ECMO) frequently experience bleeding, which is in part caused by acquired von Willebrand syndrome (vWS). Prior in vitro studies have shown that the addition of recombinant von Willebrand Factor (vWF) to ECMO patient blood samples, normalizes platelet adhesion and thrombus formation. This study is a phase I study, where adult ECMO patients with refractory bleeding will be treated with recombinant vWF a single time. The primary objectives are to evaluate the safety, tolerability, and pharmacokinetics of recombinant vWF in adult ECMO patients.
Eligibility criteria
Qualifiers
Adult patients (18 years or greater)
On extracorporeal membrane oxygenation
Major bleeding defined by CTCAE class 3 or greater
Off systemic anticoagulation for at least 4 hours
Disqualifiers
Platelet count less than 40 x 109/L
International normalized ratio> 2.0
Fibrinogen less than 150 mg/dL
Current participation in another clinical trial (interventional)
Trial design
Treatments tested in this trial
- Recombinant von Willebrand Factor