Status:
RECRUITING
Recombinant VWF Concentrate and ECMO
Lead Sponsor:
University of Virginia
Conditions:
Bleeding Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 th...
Detailed Description
Coagulopathic bleeding is a common complication during ECMO. Multiple studies suggest that major bleeding occurs in 30-70% of adult ECMO patients, with higher bleeding rates in post-cardiotomy shock a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06118372
Start Date
October 3 2024
End Date
December 31 2026
Last Update
October 10 2024
Active Locations (1)
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1
UVA Hospital
Charlottesville, Virginia, United States, 22903