Ignite Creation Date:
2024-05-06 @ 1:50 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04146376
Status:
RECRUITING
Last Update Posted:
2021-01-28
First Post:
2019-10-29
Brief Title:
Von Willebrand Factor in Pregnancy VIP Study
Sponsor:
Bloodworks
Organization:
Bloodworks
Study Overview
Official Title:
Von Willebrand Factor in Pregnancy VIP Study a Multicenter Study of Wilate Use in Von Willebrand Disease for Childbirth
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIP
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
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
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 ie 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 VWFAct or von Willebrand factor ristocetin cofactor VWFRCo andor Factor VIII procoagulant activity FVIIIC less than 100 percent will be used to assign patients to the non-corrector group When VWF collagen binding VWFCB laboratory monitoring can be performed patients with an isolated VWFCB 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
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 VWFAct or von Willebrand factor ristocetin cofactor VWFRCo andor Factor VIII procoagulant activity FVIIIC less than 100 percent will be used to assign patients to the non-corrector group When VWF collagen binding VWFCB laboratory monitoring can be performed patients with an isolated VWFCB 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None