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โ† Trials
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Recombinant vWF Concentrate and ECMO

RecruitingPhase 1Ages 18 Years - anyAllUniversity of Virginia
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Recombinant von Willebrand Factor
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Where

1 site
UVA Hospital
Charlottesville, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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