Using recombinant von Willebrand Factor to treat bleeding in ECMO patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I study investigates the safety, tolerability, and pharmacokinetics of recombinant von Willebrand Factor (vWF) in adult patients experiencing refractory bleeding while on extracorporeal membrane oxygenation (ECMO). The study aims to address the common complication of coagulopathic bleeding in ECMO patients, which is often linked to acquired von Willebrand syndrome. By administering recombinant vWF, the researchers hope to improve platelet adhesion and reduce bleeding episodes. The study will involve a single treatment of recombinant vWF and will monitor patient responses to evaluate its effectiveness.

Why it matters

Who can join: the full rules

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

Where it's running

• UVA Hospital
  Charlottesville, Virginia, United States Recruiting

Study contacts

• Principal investigator: Michael Mazzeffi, MD — Uva
• Study coordinator: Michael Mazzeffi, MD
• Email: syy4wa@uvahealth.org
• Phone: 434-924-9520

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.