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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Virginia
UVA Hospital
RECRUITING
Charlottesville
Contact Information
Primary
Michael Mazzeffi, MD
syy4wa@uvahealth.org
434-924-9520
Backup
Keita Ikeda, PhD
KI2D@uvahealth.org
434-924-2283
Time Frame
Start Date: 2024-10-03
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 20
Treatments
Experimental: Treatment with recombinant vWF
ECMO patients with major bleeding who are enrolled in the trial will receive treatment with recombinant von Willebrand Factor a single time. The dose will be 50 IU/kg and the drug will be given intravenously.
Sponsors
Leads: University of Virginia

This content was sourced from clinicaltrials.gov