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NCT06118372 · ClinicalTrials.gov registry record · Phase 1
Recombinant vWF Concentrate and ECMO
A Phase 1 study of Bleeding Disorder, sponsored by University of Virginia.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT06118372: Recruiting Phase 1 study of Bleeding Disorder, sponsored by University of Virginia.
NCT06118372 is a Phase 1 study of Bleeding Disorder that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 12 participants, below the 1,267-participant average among 3 other Bleeding Disorder trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06118372, a Phase 1 study of Bleeding Disorder, is actively recruiting participants, sponsored by University of Virginia.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Recombinant von Willebrand Factor
Study Locations (1)
Virginia
- UVA Hospital - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2024-10-03 |
| Est. Completion | 2027-02-28 |
| Phase | Phase 1 |
What NCT06118372 shows while recruiting
NCT06118372 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,267-participant average among 3 other Bleeding Disorder trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Bleeding Disorder appearing as the primary indexed condition, and to 1 intervention - of which Recombinant von Willebrand Factor is the first listed.
NCT06118372 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT06118372 about?
NCT06118372 is a clinical study titled "Recombinant vWF Concentrate and ECMO". 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 plat...
What is the current status of trial NCT06118372?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2024-10-03. Estimated completion is 2027-02-28.
What conditions does trial NCT06118372 study?
This clinical trial studies the following conditions: Bleeding Disorder.
What interventions are being tested in trial NCT06118372?
The interventions under investigation include: Recombinant von Willebrand Factor (DRUG).
Who is sponsoring clinical trial NCT06118372?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06118372 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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