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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 February 2021 |
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Main ID: |
NCT04146376 |
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Date of registration:
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29/10/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Von Willebrand Factor in Pregnancy (VIP) Study
VIP |
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Scientific title:
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Von Willebrand Factor in Pregnancy (VIP) Study: A Multicenter Study of Wilate Use in Von Willebrand Disease for Childbirth |
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Date of first enrolment:
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October 12, 2019 |
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Target sample size:
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110 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04146376 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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United States
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Contacts
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Name:
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Barbara A Konkle, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bloodworks |
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Name:
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Sarah Ruuska, MPH |
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Address:
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Telephone:
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206-689-6193 |
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Email:
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sarahru@bloodworksnw.org |
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Affiliation:
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Name:
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Peter A Kouides, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mary M. Gooley Hemophilia Center |
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Name:
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Jill M Johnsen, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Bloodworks |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Von Willebrand Diseases
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Intervention(s)
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Other: Use of a postpartum diary and additional blood draws
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Other: Use of a postpartum diary and additional blood draws.
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Drug: VWF replacement therapy with Wilate
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Drug: Tranexamic acid
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Primary Outcome(s)
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rate of primary postpartum hemorrhage (PPH)
[Time Frame: within 24 hours postpartum]
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Secondary Outcome(s)
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rate of secondary postpartum hemorrhage (PPH)
[Time Frame: 24 hours to 6 weeks postpartum]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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