Home › NCT06118372
Recombinant vWF Concentrate and ECMO
Safety and Tolerability of Recombinant Von Willebrand Factor Concentrate in Adult ECMO Patients With Major Bleeding: A Phase I Study
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: 1. Adult patients (18 years or greater) 2. On extracorporeal membrane oxygenation 3. Major bleeding defined by CTCAE class 3 or greater 4. Off systemic anticoagulation for at least 4 hours Exclusion Criteria: 1. Platelet count less than 40 x 109/L 2. International normalized ratio\> 2.0 3. Fibrinogen less than 150 mg/dL 4. Current participation in another clinical trial (interventional) 5. Heparin induced thrombocytopenia (active) 6. Acute liver failure, as indicated by bilirubin \>20 mg/dL or new onset hepatic encephalopathy 7. Patient or legally authorized representative unable to give informed consent 8. Allergy to recombinant von Willebrand Factor or any component of the product based on prior exposure 9. 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 10. Known congenital or acquired thrombophilia 11. 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. 12. History of hypersensitivity to vWF concentrate 13. Known history of vWF antibodies
About the study
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.
What is being tested
- Recombinant von Willebrand Factor (drug)
Sponsor: University of Virginia · Participants: 12 · Started: Oct 3, 2024
Contact the study team
- Michael Mazzeffi, MD · Phone: 434-924-9520
- Keita Ikeda, PhD · Phone: 434-924-2283
Official record on ClinicalTrials.gov — NCT06118372
Locations in the U.S.
| Virginia | UVA Hospital, Charlottesville |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.