Recombinant von Willebrand Factor for Bleeding in ECMO Patients
This study is testing a drug called Recombinant von Willebrand Factor in adult patients who are on extracorporeal membrane oxygenation (ECMO), a life support machine, and are experiencing significant bleeding. Patients on ECMO often develop a bleeding problem called acquired von Willebrand syndrome (vWS). Recombinant von Wille Willebrand Factor is already approved for other types of von Willebrand Disease, and this study aims to see if a single dose can safely and effectively reduce bleeding in ECMO patients. The study will enroll 12 adult patients who are on ECMO, have major bleeding, and meet specific blood test criteria. Researchers will look at how safe the drug is, how well your body handles it, and how long it stays in your system.
- Study design
- This is an interventional study, meaning participants will receive a treatment. It plans to enroll 12 adult patients.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for 30 days after treatment. Blood levels of the drug will be measured for 96 hours after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Recombinant vWF Concentrate and ECMO
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Michael Mazzeffi, MD · PRINCIPAL_INVESTIGATOR · UVA
Who to contact
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What this trial measures
- Serious Adverse Events30 days after treatment
Events that 1) cause death, 2) are life-threatening, 3) cause permanent damage, 4) required intervention to prevent harm, or 5) are otherwise serious and jeopardize the patient's safety.
- Area under the plasma concentration curve from zero to infinity (h × U/dL)96 hours after treatment
Pharmacokinetic parameter
- Plasma half-life (hours)96 hours after treatment
Pharmacokinetic parameter
- Mean residence time (hours)96 hours after treatment
Pharmacokinetic parameter
- Clearance (mL/kg per hour)96 hours after treatment
Pharmacokinetic parameter
- Volume at a steady state (dL/kg)96 hours after treatment
Pharmacokinetic parameter
- Maximum concentration (U/dL)96 hours after treatment
Pharmacokinetic parameter
- Time to maximum concentration (hours)96 hours after treatment
Pharmacokinetic parameter
- Incremental recovery ([U/dL]/[U VWF: RCo/kg] for VWF)96 hours after treatment
Pharmacokinetic parameter