Recombinant vWF Concentrate and ECMO
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 th
| Condition(s) | Bleeding Disorder |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 sa |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Virginia |
| Locations | Charlottesville, Virginia, United States |
| Start date | 2024-10-03 |
| NCT ID | NCT06118372 |
| Official listing | https://clinicaltrials.gov/study/NCT06118372 |