RecruitingPhase 1NCT06118372

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

Sponsor

University of Virginia

Enrollment

12 participants

Start Date

Oct 3, 2024

Study Type

INTERVENTIONAL

Conditions

Bleeding Disorder

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

Adult patients (18 years or greater)
On extracorporeal membrane oxygenation
Major bleeding defined by CTCAE class 3 or greater
Off systemic anticoagulation for at least 4 hours

Exclusion Criteria13

Platelet count less than 40 x 109/L
International normalized ratio\> 2.0
Fibrinogen less than 150 mg/dL
Current participation in another clinical trial (interventional)
Heparin induced thrombocytopenia (active)
Acute liver failure, as indicated by bilirubin \>20 mg/dL or new onset hepatic encephalopathy
Patient or legally authorized representative unable to give informed consent
Allergy to recombinant von Willebrand Factor or any component of the product based on prior exposure
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
Known congenital or acquired thrombophilia
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.
History of hypersensitivity to vWF concentrate
Known history of vWF antibodies

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Interventions

DRUGRecombinant 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.