Von Willebrand Factor in Pregnancy (VIP) Study (VIP)

January 26, 2021 updated by: Jill Johnsen, Bloodworks

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

For pregnant women with von Willebrand disease (VWD) who by the third trimester do not have von Willebrand factor (VWF) or factor VIII (FVIII) levels > 50-100%, specific guidance is lacking for delivery planning for how high a VWF level should be achieved. Specifically, guidance is lacking on whether VWF replacement therapy should target a VWF minimum level in the 100-150% range, i.e., a range closer to the 200-250% levels observed in normal pregnancy.

This is a prospective, open-label, cohort study using Wilate VWF replacement therapy, trough or minimum VWF levels of 100-150% will be maintained for delivery in women with VWD whose third trimester VWF levels are <100%. This group is termed "non-correctors". Women with VWD whose third trimester VWF levels spontaneously rise to >100% will be assigned to the "corrector" group, and these women will not receive VWF replacement therapy. All patients will receive tranexamic acid for 14 days postpartum. Outcome parameters will be assessed for all patients.

The investigators or qualified research personnel will approach all consecutive pregnant VWD patients until 65 non-corrector patients have completed the study protocol, and up to 30 corrector patients have completed the study protocol. Patients with gestational week 34-38 von Willebrand factor activity (VWF:Act) or von Willebrand factor ristocetin cofactor (VWF:RCo), and/or Factor VIII procoagulant activity (FVIII:C) less than 100 percent will be used to assign patients to the non-corrector group. When VWF collagen binding (VWF:CB) laboratory monitoring can be performed, patients with an isolated VWF:CB type 2 defect can also be enrolled.

Rate of primary postpartum hemorrhage, severe postpartum hemorrhage, secondary postpartum hemorrhage will be measured. Safety and secondary laboratory measures will be assessed.

Study Type

Observational

Enrollment (Anticipated)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Peoria, Illinois, United States, 61615
        • Recruiting
        • Bleeding & Clotting Disorders Institute
        • Contact:
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Tulane University School of Medicine, Louisiana Center for Bleeding and Clotting Disorders
        • Principal Investigator:
          • Maissaa Janbain, MD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Washington Center for Bleeding Disorders at Bloodworks
        • Contact:
        • Principal Investigator:
          • Jill Johnsen, MD

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The investigators or qualified research personnel will approach all consecutive pregnant VWD patients. Patients who meet all of the inclusion criteria and none of the exclusion criteria are eligible for this study.

Description

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
  • VWF and Factor VIII (FVIII) levels obtained in gestational weeks 34-38 will determine enrollment in the non-corrector or corrector group:
  • Patients with gestational week 34-38 VWF:Ag, VWF:Act (or VWF:RCo), or FVIII:Act 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 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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-Corrector
Patients with gestational week 34-38 von Willebrand factor activity, or von Willebrand factor ristocetin cofactor, or Factor VIII procoagulant activity less than 100 percent will be termed non-correctors. When laboratory monitoring can be performed, patients with an isolated von Willebrand factor collagen binding type 2 defect, von Willebrand factor collagen binding less than 100 percent can also be enrolled and determined as a non-corrector.
Other: Use of a postpartum diary and additional blood draws

A diary will be used to capture postpartum hemorrhage (PPH), Wilate and tranexamic acid use, other drug use, bleeding episodes, and treatment schedules.

Several blood draws additional to what is expected for routine clinical care will also be taken.

Drug: VWF replacement therapy with Wilate
This study design uses on-label Wilate for VWF replacement therapy for delivery and the postpartum period in VWD patients whose VWF levels are <100% in the third trimester of pregnancy
Drug: Tranexamic acid
This study design uses tranexamic acid for prophylaxis for postpartum hemorrhage for all women with VWD
Corrector
Patients with von Willebrand factor parameter levels greater than or equal to 100 percent self-corrected at gestational weeks 34-38 will be termed correctors.
Drug: Tranexamic acid
This study design uses tranexamic acid for prophylaxis for postpartum hemorrhage for all women with VWD
Other: Use of a postpartum diary and additional blood draws.

A diary will be used to capture postpartum hemorrhage (PPH), tranexamic acid use, other drug use, bleeding episodes, and treatment schedules.

Several blood draws additional to what is expected for routine clinical care will also be taken.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of primary postpartum hemorrhage (PPH)
Time Frame: within 24 hours postpartum
estimated blood loss greater than or equal to 1000 mL, or severe PPH defined as estimated blood loss greater than 2000 mL within 24 hours postpartum, as indicated by: visual estimation, pre- and post- weight of blood soaked materials, photospectrometry
within 24 hours postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of secondary postpartum hemorrhage (PPH)
Time Frame: 24 hours to 6 weeks postpartum
excessive blood loss: any transfusions not anticipated in the antepartum birth plan, including number and type of blood products transfused within 48 hours after treatment, any transfusions not anticipated in the antepartum birth plan, including number and type of blood products transfused beyond 48 hours after treatment, change in antepartum hemoglobin, change in pictorial blood assessment chart (PBAC) score, number of patients needing interventions for bleeding (e.g., use of Bakri balloon, angiographic embolization, B-Lynch sutures, surgical arterial ligation, or hysterectomy for persistent bleeding), iron levels (serum iron, TIBC, and ferritin) 6 weeks postpartum
24 hours to 6 weeks postpartum

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
occurrence of venous or arterial thrombus
Time Frame: up to 42 days postpartum
clinically documented venous or arterial thrombus
up to 42 days postpartum
occurrence of infusion-related reactions
Time Frame: up to 42 days postpartum
clinically documented infusion-related reactions
up to 42 days postpartum
laboratory assessment of efficacy and VWF replacement
Time Frame: up to 42 days postpartum
central laboratory assessment of VWF parameters relative to bleeding
up to 42 days postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bloodworks

Collaborators

Ergomed
Octapharma
Mary M. Gooley Hemophilia Center

Investigators

  • Principal Investigator: Jill M Johnsen, M.D., Bloodworks
  • Principal Investigator: Barbara A Konkle, M.D., Bloodworks
  • Principal Investigator: Peter A Kouides, M.D., Mary M. Gooley Hemophilia Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

October 12, 2019

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

October 29, 2019

First Submitted That Met QC Criteria

October 29, 2019

First Posted (Actual)

October 31, 2019

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIPStudy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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