Recombinant vWF Concentrate and ECMO

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT06118372
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Bleeding Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Recombinant von Willebrand Factor — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 3, 2024
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment with recombinant vWF
    ECMO patients with major bleeding who are enrolled in the trial will receive treatment with recombinant von Willebrand Factor a single time. The dose will be 50 IU/kg and the drug will be given intravenously.

Primary Outcome Measure

Serious Adverse Events [ Time Frame: 30 days after treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UVA HospitalCharlottesvilleVirginia22903
Michael Mazzeffi, MD
[email protected]
434-924-9520
Keita Ikeda, PhD
[email protected]
434-924-2283

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By research site
UVA Hospital· Charlottesville, VA

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