Recombinant vWF Concentrate and ECMO
ConditionBleeding Disorder
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Virginia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Recombinant von Willebrand Factor
DrugRecombinant 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.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Treatment with recombinant vWFExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Serious Adverse Events
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.
Time frame
30 days after treatment2
Area under the plasma concentration curve from zero to infinity (h × U/dL)
Pharmacokinetic parameter
Time frame
96 hours after treatment3
Plasma half-life (hours)
Pharmacokinetic parameter
Time frame
96 hours after treatment4
Mean residence time (hours)
Pharmacokinetic parameter
Time frame
96 hours after treatmentSecondary outcomes
1
Change in bleeding severity class
The study's secondary endpoint will be any change in consensus definitions in Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 bleeding class 24 hours after treatment with Vonvendi.
Time frame
24 hours after treatment2
Change in bleeding/drain output volume from existing surgical drains
Change in total amount of bleeding/output from existing surgical drains will be a secondary study outcome.
Time frame
24 hours after treatmentSponsors and contacts
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Source ClinicalTrials.gov