Abstract Number: PB0944
Meeting: ISTH 2021 Congress
Background: Von Willebrand disease (VWD) is a quantitative or qualitative deficiency of von Willebrand factor (VWF) that is associated with a 1.5-fold increased odds of postpartum hemorrhage (PPH). This risk persists despite VWF replacement and may be life-threatening, lead to hysterectomy, and require blood transfusion with its attendant risk. We hypothesize the increased bleeding risk is due to physiologic postpartum fibrinolysis in the setting of VWF deficiency. We propose that the use of the antifibrinolytic agent tranexamic acid (TA), given IV within the first 3 hours of delivery, will reduce PPH to a greater degree than rVWF alone.
Aims: We designed a single-center pilot study to establish the safety and feasibility of enrollment, drug delivery, and lab collection to conduct a future multicenter randomized trial comparing rVWF + TA vs. rVWF alone.
Methods: This is a phase III, randomized, open-label pilot trial of rVWF 80 IU/kg at delivery and day 1 and 2 postpartum with or without TA 1 gm IV administered within 3 hours of delivery in 20 women with VWD to prevent PPH (Fig 1). The primary endpoint is a reduction in PPH determined by quantitative blood loss at delivery. Secondary endpoints include patient-reported pictorial blood loss estimate, safety, tolerability, and coagulation studies. Statistical comparisons are descriptive. Informed consent will be obtained under University of Pittsburgh Institutional Review Board approval, PRO20030186, prior to trial activities. This trial is registered at clinicaltrials.gov NCT04344860.
Results: In collaboration with obstetric colleagues, we have completed IRB, DSMB, and regulatory requirements, established a redcap database, a drug-dose calculator, reporting forms, and operations manual.
Conclusions: Women with VWD experience PPH despite VWF replacement. In this pilot phase III trial comparing rVWF +TA to rVWF alone, in women with VWD is proven feasible, we will initiate a multicenter phase III randomized trial.
To cite this abstract in AMA style:Machin N, Caritis S, Seaman C, Brooks M, Vehec D, Rode M, Ivanco D, Fischer D, Zowacki D, Ragni M. The von Willebrand Disease-Woman (VWD-Woman) Trial: A Pilot Study Comparing Recombinant von Willebrand Factor (rVWF) plus Tranexamic Acid (TA) vs. rVWF Alone in the Prevention of Postpartum Hemorrhage in Women with von Willebrand Disease [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/the-von-willebrand-disease-woman-vwd-woman-trial-a-pilot-study-comparing-recombinant-von-willebrand-factor-rvwf-plus-tranexamic-acid-ta-vs-rvwf-alone-in-the-prevention-of-postpartum-hemorrhage/. Accessed December 6, 2023.
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