Managing von Willebrand Disease in Pregnant Women

Von Willebrand Factor in Pregnancy (VIP) Study: A Multicenter Study of Wilate Use in Von Willebrand Disease for Childbirth

This study is testing if giving a treatment to boost von Willebrand factor levels in pregnant women with von Willebrand disease can help prevent heavy bleeding after delivery.

Quick facts

• Study type: Observational
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University of Washington (Academic / other)
• Locations: 11 sites (Aurora, Colorado and 10 other locations)
• Trial ID: NCT04146376 on ClinicalTrials.gov

What this trial studies

This observational study focuses on pregnant women with von Willebrand disease (VWD) who have low von Willebrand factor (VWF) levels in the third trimester. It aims to determine the optimal VWF levels needed to minimize postpartum hemorrhage by using Wilate VWF replacement therapy to maintain VWF levels between 100-150% during delivery. Participants will be categorized into 'non-correctors' and 'correctors' based on their VWF levels, and outcomes will be assessed for both groups. The study also includes the use of tranexamic acid postpartum to further evaluate safety and effectiveness.

Who should consider this trial

Good fit: Ideal candidates are pregnant women diagnosed with von Willebrand disease who have low VWF levels in the third trimester.

Not a fit: Patients with other concurrent hemostatic disorders or those whose VWF levels are adequate may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce the risk of postpartum hemorrhage in women with von Willebrand disease.

How similar studies have performed: While there is limited data on this specific approach, similar studies have shown promise in managing bleeding disorders during pregnancy.

Eligibility criteria

Inclusion Criteria:

* von Willebrand Disease (VWD) patients defined prepartum as Type 1 per National Heart, Lung, and Blood Institute (NHLBI) criterion of von Willebrand Factor (VWF) level less than 30 percent, or Type 2, or Type 3 VWD

or

* A diagnosis of VWD and VWF and Factor VIII (FVIII) levels obtained in gestational weeks 34-38 that determine enrollment in the non-corrector group:
* Patients with gestational week 34-38 VWF:Ag, VWF:Act (or VWF:RCo), or FVIII:C less than 100 percent will be enrolled in the non-corrector group. In patients with an isolated VWF:CB type 2 defect, VWF:CB less than 100 percent can also be determined as a non-corrector
* Patients with all VWF parameter levels greater than or equal to 100 percent self-corrected at gestational weeks 34-38 will be enrolled in the corrector group

Written informed consent from the patient prepartum, before gestational week 39

Exclusion Criteria:

* Presence of a clinical contraindication to receive wilate or tranexamic acid, as determined by the health care provider, such as a prior drug reaction
* Presence of other concurrent disorder of hemostasis, platelet dysfunction, or collagen disorders
* Presence of liver disease or renal disease, clinical suspicion or diagnosis of preeclampsia or eclampsia, HELLP syndrome, TTP, DIC, or other acquired vasculopathy or coagulopathy
* Age less than 18 years
* Inability of the local laboratory to monitor the VWF laboratory tests needed during the course of treatment to determine Wilate dosing adjustments

Where this trial is running

Aurora, Colorado and 10 other locations

• University of Colorado — Aurora, Colorado, United States (Recruiting)
• Yale University — New Haven, Connecticut, United States (Recruiting)
• University of Miami — Miami, Florida, United States (Recruiting)
• Emory University — Atlanta, Georgia, United States (Recruiting)
• Bleeding & Clotting Disorders Institute — Peoria, Illinois, United States (Recruiting)
• Tulane University School of Medicine, Louisiana Center for Bleeding and Clotting Disorders — New Orleans, Louisiana, United States (Recruiting)
• Oregon Health & Science University — Portland, Oregon, United States (Withdrawn)
• The Pennsylvania State University — Hershey, Pennsylvania, United States (Recruiting)
• Vanderbilt University — Nashville, Tennessee, United States (Recruiting)
• University of Utah — Salt Lake City, Utah, United States (Recruiting)
• Washington Center for Bleeding Disorders — Seattle, Washington, United States (Recruiting)

Study contacts

• Principal investigator: Jill M Johnsen, M.D. — University of Washington
• Study coordinator: Central Study Contact

Conditions Von Willebrand Diseases; von Willebrand Disease; von Willebrand Factor; postpartum hemorrhage