Recombinant vWF Concentrate and ECMO

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Virginia

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

Treatment groups

12 Participants
are divided into 1 treatment group

Sponsors and collaborators