Von Willebrand Factor in Pregnancy (VIP) Study

Launched by UNIVERSITY OF WASHINGTON · Oct 29, 2019

Keywords

ClinConnect Summary

The VIP Study is a clinical trial focused on pregnant women who have von Willebrand disease (VWD), a bleeding disorder that affects blood clotting. The researchers want to find out how to safely manage bleeding risks during delivery by using a treatment called Wilate, which helps raise levels of a specific protein important for blood clotting (called von Willebrand factor) to a target range. The main goal is to see how many women experience heavy bleeding after giving birth.

To be eligible for this study, women must be diagnosed with VWD and have specific blood test results that show low levels of von Willebrand factor or another related protein by their third trimester. Participants will receive Wilate treatment to maintain certain blood levels around the time of delivery and for a short period afterward. The study is currently looking for women aged 18 and older who meet these criteria. Overall, this trial is important for improving care and safety for expectant mothers with von Willebrand disease.

Gender

FEMALE

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