NCT06118372 · University of Virginia
Recombinant vWF Concentrate and ECMO
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Recombinant 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.
Primary outcome measures
Serious Adverse Events
Time frame: 30 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)
Time frame: 96 hours after treatment
Pharmacokinetic parameter
Plasma half-life (hours)
Time frame: 96 hours after treatment
Pharmacokinetic parameter
Mean residence time (hours)
Time frame: 96 hours after treatment
Pharmacokinetic parameter
Clearance (mL/kg per hour)
Time frame: 96 hours after treatment
Pharmacokinetic parameter
Volume at a steady state (dL/kg)
Time frame: 96 hours after treatment
Pharmacokinetic parameter
Maximum concentration (U/dL)
Time frame: 96 hours after treatment
Pharmacokinetic parameter
Time to maximum concentration (hours)
Time frame: 96 hours after treatment
Pharmacokinetic parameter
Incremental recovery ([U/dL]/[U VWF: RCo/kg] for VWF)
Time frame: 96 hours after treatment
Pharmacokinetic parameter
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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
Where
- Charlottesville, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 5, 2026 · Source of record for eligibility and locations