Actively Recruiting
Recombinant vWF Concentrate and ECMO
Led by University of Virginia · Updated on 2026-02-05
12
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Recombinant vWF Concentrate and ECMO
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Platelet count less than 40 x 10^9/L
- International normalized ratio greater than 2.0
- Fibrinogen less than 150 mg/dL
- Current participation in another interventional clinical trial
- Active heparin induced thrombocytopenia
- Acute liver failure indicated by bilirubin greater than 20 mg/dL or new onset hepatic encephalopathy
- Patient or legally authorized representative unable to give informed consent
- Allergy to recombinant von Willebrand Factor or any component of the product
- Positive pregnancy test during the same hospital admission for women of childbearing age
- Known congenital or acquired thrombophilia
- History of deep venous thrombosis, pulmonary embolism, circuit thrombosis, disseminated intravascular coagulation, ischemic stroke, ST elevation myocardial infarction, or arterial thrombosis in the last 3 months
- History of hypersensitivity to von Willebrand Factor concentrate
- Known history of von Willebrand Factor antibodies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UVA Hospital
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
M
Michael Mazzeffi, MD
CONTACT
K
Keita Ikeda, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here