Status:
COMPLETED
Prevent Postpartum Hemorrhage in Women With Von Willebrand Disease: The VWD-WOMAN Trial
Lead Sponsor:
Nicoletta C Machin
Conditions:
Von Willebrand Diseases
Postpartum Hemorrhage
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This is a single-center randomized phase III clinical trial, the VWD-Woman Trial, in which 20 pregnant subjects with von Willebrand disease (VWD), defined as VWF ristocetin co-factor activity (VWF:RCo...
Detailed Description
The purpose of this 8-week single center, randomized, open-label phase III trial to compare recombinant von Willebrand factor (rVWF, Vonvendi®)) plus tranexamic acid (TA, Cyclokapron®) vs. rVWF alone ...
Eligibility Criteria
Inclusion
- Pregnant females \>= 18 years of age
- Confirmed VWD, as defined by VWF:RCo \< 0.50 IU/dL and previous history of bleeding
- Willingness to have blood drawn
- Willing to be randomized to one of two treatments at delivery and for 2 days postpartum.
- Willing to keep a diary for 3 weeks of postpartum bleeding by pictorial assessment chart (PBAC) and any blood products, transfusion, or medications taken.
- Willing to return at 21 days for final blood draw and review of diary.
Exclusion
- Any bleeding disorder other than VWD; or past thrombotic disease of other bleeding disorders.
- Previous thrombosis, cardiac disease, congestive failure, arrhythmia, hypertension, MI, or stroke.
- Platelet count \< 100,000/ ul.
- Past allergic reaction to VWF or tranexamic acid.
- Surgery within the past 8 weeks.
- Inability to comply with study protocol requirements.
- Concomitant use of antiplatelet drugs, anticoagulants, or NSAIDs. Aspirin will be allowed for preeclampsia prevention.
- Treatment with DDAVP, cryoprecipitate, whole blood, plasma or plasma derivatives containing substantial quantities of VWF within 5 days of study.
- History of renal disease.
- Inability to comply with study requirements.
Key Trial Info
Start Date :
June 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04344860
Start Date
June 4 2021
End Date
September 1 2024
Last Update
October 31 2025
Active Locations (1)
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1
Hemophilia Center of Western PA
Pittsburgh, Pennsylvania, United States, 15213