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.
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Serious Adverse Events
Timeframe: 30 days after treatment
Area under the plasma concentration curve from zero to infinity (h × U/dL)
Timeframe: 96 hours after treatment
Plasma half-life (hours)
Timeframe: 96 hours after treatment
Mean residence time (hours)
Timeframe: 96 hours after treatment
Clearance (mL/kg per hour)
Timeframe: 96 hours after treatment
Volume at a steady state (dL/kg)
Timeframe: 96 hours after treatment
Maximum concentration (U/dL)
Timeframe: 96 hours after treatment
Time to maximum concentration (hours)
Timeframe: 96 hours after treatment
Incremental recovery ([U/dL]/[U VWF: RCo/kg] for VWF)
Timeframe: 96 hours after treatment