Recombinant vWF Concentrate and ECMO

• Status: Not yet recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Virginia

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