Von Willebrand Factor in Pregnancy (VIP) Study (VIP)
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| ClinicalTrials.gov Identifier: NCT04146376 |
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Recruitment Status :
Recruiting
First Posted : October 31, 2019
Last Update Posted : January 28, 2021
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Sponsor:
Bloodworks
Collaborators:
Mary M. Gooley Hemophilia Center
Ergomed
Octapharma
Information provided by (Responsible Party):
Jill Johnsen, Bloodworks
| Tracking Information | ||||||||||
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| First Submitted Date | October 29, 2019 | |||||||||
| First Posted Date | October 31, 2019 | |||||||||
| Last Update Posted Date | January 28, 2021 | |||||||||
| Actual Study Start Date | October 12, 2019 | |||||||||
| Estimated Primary Completion Date | June 2023 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
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
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| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures |
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
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| Original Secondary Outcome Measures | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures |
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| Original Other Pre-specified Outcome Measures | Same as current | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | Von Willebrand Factor in Pregnancy (VIP) Study | |||||||||
| Official Title | Von Willebrand Factor in Pregnancy (VIP) Study: A Multicenter Study of Wilate Use in Von Willebrand Disease for Childbirth | |||||||||
| Brief Summary | 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. |
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| 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. |
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| Study Type | Observational | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Retention: Samples With DNA Description: Plasma collection for coagulation parameters Whole blood collection for DNA and RNA analysis Cord blood sample
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| 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. | |||||||||
| Condition | Von Willebrand Diseases | |||||||||
| Intervention |
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| Study Groups/Cohorts |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Recruiting | |||||||||
| Estimated Enrollment |
110 | |||||||||
| Original Estimated Enrollment | Same as current | |||||||||
| Estimated Study Completion Date | June 2023 | |||||||||
| Estimated Primary Completion Date | June 2023 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts |
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| Listed Location Countries | United States | |||||||||
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| Administrative Information | ||||||||||
| NCT Number | NCT04146376 | |||||||||
| Other Study ID Numbers | VIPStudy | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Current Responsible Party | Jill Johnsen, Bloodworks | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor | Bloodworks | |||||||||
| Original Study Sponsor | Same as current | |||||||||
| Collaborators |
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| Investigators |
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| PRS Account | Bloodworks | |||||||||
| Verification Date | January 2021 | |||||||||