Prevent Postpartum Hemorrhage in Women With Von Willebrand Disease: The VWD-WOMAN Trial

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: Female

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) <0.50 IU/ml (historic) and previous history of bleeding are enrolled. Subjects will include women with VWD age 18 years and older, excluding those who have a bleeding disorder other than VWD. Once enrolled, subjects who meet all of the inclusion and none of the exclusion criteria will be randomized to recombinant Von Willebrand factor (rVWF, Vonvendi ®) with Tranexamic Acid (TA, Cyclokapron®); or recombinant Von Willebrand factor (rVWF, Vonvendi®) alone to prevent postpartum hemorrhage after vaginal or caesarean delivery. The primary endpoint is quantitative blood loss (QBL) by a labor suite nurse at delivery. Secondary endpoints include safety assessment for postpartum lochial blood loss by Pictorial Blood Assessment Chart (PBAC), transfusion, blood products, thromboembolic events, and hysterectomy within 21 days; and mechanism of PPH reduction by VWF assays (VWF:RCo, VWF:Ag, VIII:C), fibrinogen, and d-dimer. Blood draws are at 5 time points, including at 36 weeks' gestation (screening), on admission for childbirth, and at 1 day, 2 days, and 21 days after delivery. The VWD-Woman Trial is considered greater than minimal risk as study drugs are given at delivery and special coagulation studies are obtained.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Margaret Ragni
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

1. Pregnant females >= 18 years of age

2. Confirmed VWD, as defined by VWF:RCo < 0.50 IU/dL and previous history of bleeding

3. Willingness to have blood drawn

4. Willing to be randomized to one of two treatments at delivery and for 2 days postpartum.

5. Willing to keep a diary for 3 weeks of postpartum bleeding by pictorial assessment chart (PBAC) and any blood products, transfusion, or medications taken.

6. Willing to return at 21 days for final blood draw and review of diary.

Exclusion Criteria:

1. Any bleeding disorder other than VWD; or past thrombotic disease of other bleeding disorders.

2. Previous thrombosis, cardiac disease, congestive failure, arrhythmia, hypertension, MI, or stroke.

3. Platelet count < 100,000/ ul.

4. Past allergic reaction to VWF or tranexamic acid.

5. Surgery within the past 8 weeks.

6. Inability to comply with study protocol requirements.

7. Concomitant use of antiplatelet drugs, anticoagulants, aspirin or NSAIDs.

8. Treatment with DDAVP, cryoprecipitate, whole blood, plasma or plasma derivatives containing substantial quantities of VWF within 5 days of study.

9. History of renal disease.

10. Inability to comply with study requirements.