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Von Willebrand Factor in Pregnancy (VIP) Study

Recruitingn/aAges 18 Years - anyFemaleUniversity of Washington
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Use of a postpartum diary and additional blood draws
  • VWF replacement therapy with Wilate
  • Tranexamic acid
  • Use of a postpartum diary and additional blood draws.
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Where

11 sites
University of Colorado
Aurora, United States
Yale University
New Haven, United States
University of Miami
Miami, United States
Emory University
Atlanta, United States
Bleeding & Clotting Disorders Institute
Peoria, United States
Tulane University School of Medicine, Louisiana Center for Bleeding and Clotting Disorders
New Orleans, United States
Oregon Health & Science University
Portland, United States
The Pennsylvania State University
Hershey, United States

โ€ฆand 3 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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