RECRUITING

Von Willebrand Factor in Pregnancy (VIP) Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-10-12
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04146376

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * 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:
  3. * 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
  4. * 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
  1. * Presence of other concurrent disorder of hemostasis, platelet dysfunction, or collagen disorders
  2. * 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
  3. * Age less than 18 years
  4. * Inability of the local laboratory to monitor the VWF laboratory tests needed during the course of treatment to determine Wilate dosing adjustments

Contacts and Locations

Study Contact

Central Study Contact
CONTACT
919-792-3740
VIP.Study@ergomedgroup.com

Principal Investigator

Jill M Johnsen, M.D.
PRINCIPAL_INVESTIGATOR
University of Washington
Barbara A Konkle, M.D.
PRINCIPAL_INVESTIGATOR
Washington Center for Bleeding Disorders
Peter A Kouides, M.D.
PRINCIPAL_INVESTIGATOR
Mary M. Gooley Hemophilia Center

Study Locations (Sites)

University of Colorado
Aurora, Colorado, 80045
United States
Yale University
New Haven, Connecticut, 06510
United States
University of Miami
Miami, Florida, 33136
United States
Emory University
Atlanta, Georgia, 30308
United States
Bleeding & Clotting Disorders Institute
Peoria, Illinois, 61615
United States
Tulane University School of Medicine, Louisiana Center for Bleeding and Clotting Disorders
New Orleans, Louisiana, 70112
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
The Pennsylvania State University
Hershey, Pennsylvania, 17033
United States
Vanderbilt University
Nashville, Tennessee, 27232
United States
University of Utah
Salt Lake City, Utah, 84108
United States
Washington Center for Bleeding Disorders at Bloodworks
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: University of Washington

  • Jill M Johnsen, M.D., PRINCIPAL_INVESTIGATOR, University of Washington
  • Barbara A Konkle, M.D., PRINCIPAL_INVESTIGATOR, Washington Center for Bleeding Disorders
  • Peter A Kouides, M.D., PRINCIPAL_INVESTIGATOR, Mary M. Gooley Hemophilia Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-10-12
Study Completion Date2026-12

Study Record Updates

Study Start Date2019-10-12
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • von Willebrand Disease
  • von Willebrand Factor
  • postpartum hemorrhage

Additional Relevant MeSH Terms

  • Von Willebrand Diseases