Recruiting
Phase 1

VWF & ECMO

Sponsor:

University of Virginia

Code:

NCT06118372

Conditions

Bleeding Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Recombinant von Willebrand Factor

Study Details

Brief 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.

Conditions

Bleeding Disorder

Study ID

NCT06118372

Start date

Oct 3, 2024

Status verified date

Feb, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment with recombinant vWF

ECMO patients with major bleeding who are enrolled in the trial will receive treatment with recombinant von Willebrand Factor a single time. The dose will be 50 IU/kg and the drug will be given intravenously.

Interventions

Recombinant von Willebrand Factor

Recombinant von Willebrand Factor is a drug that is currently FDA approved to treat patients with certain types of von Willebrand Disease. In the current trial it will be used to treat ECMO patients who have acquired von Willebrand syndrome.

Primary outcome measure

  • Serious Adverse Events [ Time Frame: 30 days after treatment ]
  • Area under the plasma concentration curve from zero to infinity (h × U/dL) [ Time Frame: 96 hours after treatment ]
  • Plasma half-life (hours) [ Time Frame: 96 hours after treatment ]
  • Mean residence time (hours) [ Time Frame: 96 hours after treatment ]
  • Clearance (mL/kg per hour) [ Time Frame: 96 hours after treatment ]
  • Volume at a steady state (dL/kg) [ Time Frame: 96 hours after treatment ]
  • Maximum concentration (U/dL) [ Time Frame: 96 hours after treatment ]
  • Time to maximum concentration (hours) [ Time Frame: 96 hours after treatment ]
  • Incremental recovery ([U/dL]/[U VWF: RCo/kg] for VWF) [ Time Frame: 96 hours after treatment ]

Central Contacts and Locations

Central contacts

Locations

UVA Hospital

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

More Information

Sponsor

University of Virginia

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2026-02-05.