Safety and Tolerability of Recombinant Von Willebrand Factor Concentrate in Adult ECMO Patients with Major Bleeding: a Phase I Study
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.
• 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