Recombinant VWF Concentrate and ECMO

Description

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

Bleeding Disorder

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

Safety and Tolerability of Recombinant Von Willebrand Factor Concentrate in Adult ECMO Patients with Major Bleeding: a Phase I Study

Recombinant VWF Concentrate and ECMO

Condition
Bleeding Disorder
Intervention / Treatment

-

Contacts and Locations

Charlottesville

UVA Hospital, Charlottesville, Virginia, United States, 22903

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Virginia,

Michael Mazzeffi, MD, PRINCIPAL_INVESTIGATOR, UVA

Study Record Dates

2026-12-31