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NCT04146376 · ClinicalTrials.gov registry record
Von Willebrand Factor in Pregnancy (VIP) Study
A clinical trial of Von Willebrand Diseases, sponsored by University of Washington.
- Recruiting
- Registry status
- 110
- Enrollment target
- 11
- Study locations
NCT04146376: Recruiting study of Von Willebrand Diseases, sponsored by University of Washington.
NCT04146376 is a study of Von Willebrand Diseases that is actively recruiting participants, run by University of Washington. The registered enrollment target is 110 participants, below the 716-participant average among 5 other Von Willebrand Diseases trials with a reported enrollment target (85% lower). The trial reports 11 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04146376, a study of Von Willebrand Diseases, is actively recruiting participants, sponsored by University of Washington.
- RECRUITING
- Registry status
- 110 participants
- Enrollment target
- 11
- Study locations
Study Summary
In pregnant women with von Willebrand disease (VWD) who by the third trimester do not have von Willebrand factor (VWF) or factor VIII (FVIII) levels greater than 50-100%, specific guidance is lacking for delivery planning in terms of how high of a VWF level should be achieved to reduce bleeding. This is a prospective, open-label, cohort study in women with VWD using Wilate VWF replacement therapy to maintain trough or minimum VWF levels of 100-150% for delivery and the immediate postpartum period, followed by levels of 50-100% for 5-10 days after delivery, depending upon the route of delivery. The primary objective is to document the rate of primary postpartum hemorrhage (PPH). The secondary objective is to document further effectiveness outcomes and safety.
Primary Outcome
defined as the estimated and/or quantified blood loss greater than or equal to 1000 mL within 24 hours postpartum; unplanned transfusion of blood products related to blood loss in the first 24 hours postpartum. As a subset of primary PPH, severe primary PPH is defined as the estimated and/or quantified blood loss greater than or equal to 1500 mL and/or requirement of greater than 2 units packed red blood cells within 24 hours postpartum; primary PPH greater than 1000 mL and evidence of maternal
Conditions Studied
Interventions
- DRUG Tranexamic acid
- OTHER Use of a postpartum diary and additional blood draws
- DRUG VWF replacement therapy with Wilate
- OTHER Use of a postpartum diary and additional blood draws.
Study Locations (11)
Colorado
- University of Colorado - Aurora
Connecticut
- Yale University - New Haven
Florida
- University of Miami - Miami
Georgia
- Emory University - Atlanta
Illinois
- Bleeding & Clotting Disorders Institute - Peoria
Louisiana
- Tulane University School of Medicine, Louisiana Center for Bleeding and Clotting Disorders - New Orleans
Oregon
- Oregon Health & Science University - Portland
Pennsylvania
- The Pennsylvania State University - Hershey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2019-10-12 |
| Est. Completion | 2026-12 |
What NCT04146376 shows while recruiting
NCT04146376 is an observational study that tracks outcomes without assigning an intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 716-participant average among 5 other Von Willebrand Diseases trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Von Willebrand Diseases appearing as the primary indexed condition, and to 4 interventions - of which Tranexamic acid is the first listed.
NCT04146376 lists 11 locations in 11 states (Colorado, Connecticut, Florida).
Frequently Asked Questions
What is clinical trial NCT04146376 about?
NCT04146376 is a clinical study titled "Von Willebrand Factor in Pregnancy (VIP) Study". In pregnant women with von Willebrand disease (VWD) who by the third trimester do not have von Willebrand factor (VWF) or factor VIII (FVIII) levels greater than 50-100%, specific guidance is lacking for delivery planning in terms of how high of a VWF level should be achieved to reduce bleeding. Th...
What is the current status of trial NCT04146376?
This trial is currently recruiting. The enrollment target is 110 participants. The study started on 2019-10-12. Estimated completion is 2026-12.
What conditions does trial NCT04146376 study?
This clinical trial studies the following conditions: Von Willebrand Diseases.
What interventions are being tested in trial NCT04146376?
The interventions under investigation include: Tranexamic acid (DRUG), Use of a postpartum diary and additional blood draws (OTHER), VWF replacement therapy with Wilate (DRUG), Use of a postpartum diary and additional blood draws. (OTHER).
Who is sponsoring clinical trial NCT04146376?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04146376 being conducted?
This trial has 11 study locations across Colorado, Connecticut, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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