Recombinant vWF Concentrate and ECMO

Recruiting now · Phase 1

Conditions studied: Bleeding Disorder

In brief

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.

Key facts

Study ID

NCT06118372

Run by

University of Virginia

People needed

12

Starts

2024-10-03

Expected to finish

2027-02-28

Last updated by the study team

2026-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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)
• Heparin induced thrombocytopenia (active)
• Acute liver failure, as indicated by bilirubin >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 based on prior exposure
• Of childbearing age and positive pregnancy test during the same hospital admission, a pregnancy test will be mandatory for all women of child-bearing age
• Known congenital or acquired thrombophilia
• History of deep venous thrombosis, pulmonary embolism, circuit thrombosis, disseminated intravascular coagulation (DIC), ischemic stroke, ST elevation myocardial infarction (STEMI), or arterial thrombosis in the last 3 months.
• History of hypersensitivity to vWF concentrate
• Known history of vWF antibodies

Where it is running

• UVA Hospital — Charlottesville, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.