Von Willebrand Factor in Pregnancy (VIP) Study
ConditionVon Willebrand Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity of Washington
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
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
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
Disqualifiers
Presence of a clinical contraindication to receive wilate or tranexamic acid, as determined by the health care provider, such as a prior drug reaction
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Use of a postpartum diary and additional blood draws
Other interventionA 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.
VWF replacement therapy with Wilate
DrugThis 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
Tranexamic acid
DrugThis study design uses tranexamic acid for prophylaxis for postpartum hemorrhage for all women with VWD
Use of a postpartum diary and additional blood draws.
Other interventionA 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.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Non-Corrector3 interventions
Group B: Corrector2 interventions
Trial outcomes
Primary outcomes
1
rate of primary postpartum hemorrhage (PPH)
defined as the estimated and/or quantified blood loss greater than or equal to 1000 mL within 24 hours postpartum; unplanned transfusion of blood products related to blood loss in the first 24 hours postpartum. As a subset of primary PPH, severe primary PPH is defined as the estimated and/or quantified blood loss greater than or equal to 1500 mL and/or requirement of greater than 2 units packed red blood cells within 24 hours postpartum; primary PPH greater than 1000 mL and evidence of maternal hemodynamic instability (tachycardia, hypotension) and/or end organ damage with no other etiology (oliguria, creatinine greater than 0.8, etc.)
Time frame
within 24 hours postpartumSecondary outcomes
1
rate of secondary postpartum hemorrhage (PPH)
excessive blood loss: any transfusions not anticipated in the antepartum birth plan and unrelated to a primary PPH, including number and type of blood component units (blood products, red blood cells, plasma, platelets, cryoprecipitate) transfused within 48 hours after diagnosis and management; any transfusions not anticipated in the antepartum birth plan and unrelated to a primary PPH, including number and type of blood component units (blood products, red blood cells, plasma, platelets, cryoprecipitate) transfused beyond 48 hours after diagnosis and management; change in antepartum hemoglobin; change in pictorial blood assessment chart (PBAC) score; number of patients needing pharmacologic or surgical 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
Time frame
24 hours to 6 weeks postpartumOther outcomes
1
occurrence of venous or arterial thrombus
clinically documented venous or arterial thrombus
Time frame
up to 42 days postpartum2
occurrence of infusion-related reactions
clinically documented infusion-related reactions
Time frame
up to 42 days postpartum3
laboratory assessment of efficacy and VWF replacement
central laboratory assessment of VWF parameters relative to bleeding
Time frame
up to 42 days postpartumSponsors and contacts
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Source ClinicalTrials.gov