Minimize Menorrhagia in Women With Von Willebrand Disease (VWDMin)
Von Willebrand Diseases
About this trial
This is an interventional treatment trial for Von Willebrand Diseases focused on measuring menorrhagia, VWD
Eligibility Criteria
Inclusion Criteria:
- Adult females 13-45 years of age.
- Mild or moderate von Willebrand disease (VWF:RCo <0.50 IU/ml, normal multimers, past bleeding)
- Menorrhagia defined as PBAC >100 in at least one of the last two menstrual cycles.
- Regular menses, at least every 21-35 days.
- Willingness to have blood drawn
- No prior history of an allergic reaction or anaphylaxis to rVWF or TA.
- Willingness to avoid aspirin (ASA) and nonsteroidal anti-inflammatory agents (NSAIDS) during the study.
- Willingness to comply with randomization to rVWF or TA study arms.
- Willingness to keep a personal diary of menorrhagia bleeding frequency duration and severity by pictorial blood assessment chart, and any drugs or hemostatic agents taken.
- Willingness to make 4 visits and undergo blood sampling for coagulation studies, and accept randomization of two therapies for each of four consecutive menstrual cycles, including an end-of-study visit.
- Willingness to use "double-barrier" method of contraception during the study.
Exclusion Criteria:
- Any bleeding disorder other than von Willebrand disease; or past thrombotic disease
- Pregnant or lactating, or use of hormones (other than progesterone-only), or combined oral contraceptives, and contraceptive implants in past 3 months.
- Platelet count < 100,000/ul.
- Use of immunomodulatory or experimental drugs.
- Surgery within the past 8 weeks.
- Concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin or NSAIDs.
- Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives containing VWF within 5 days of study.
- Inability to comply with study requirements.
- Hypothyroidism as defined by elevated TSH.
- Iron deficiency as defined by low serum ferritin, unless iron replacement has been initiated.
- History of renal disease
Sites / Locations
- Banner MD Anderson Cancer Center
- Center for Inherited Blood Disorders (CIBD)
- University of California San Francisco
- Emory University Afflac Blood Disorders Center
- Henry Ford Hospital Medical Center
- Michigan State University
- Mayo Clinic
- Washington University St. Louis
- Cure4thekids Foundation
- Rutgers Robert Wood Johnson Medical School
- State University of New York Upstate Medical Center
- Cleveland Clinic Foundation
- Ohio State University Wexner Medical Center
- Oregon Health and Science University
- University of Pittsburgh and Hemophilia Center Western PA
- Vanderbilty University
- University of Utah
- Bloodworks Northwest
- Versiti Blood Center of Wisconsin
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Group I
Group II
Subjects randomized to Group I will receive Arm A recombinant von Willebrand factor 40 IU/kg intravenously (IV) infusion on day 1 of each of two menstrual cycles, Cycles 1 and 2. They will then be crossed over to Arm B, tranexamic acid 650 mg 2 tablets orally (po) three times daily on days 1-5 of each of two menstrual cycles, Cycles 3 and 4.
Group II will receive Arm B, tranexamic acid 650 mg 2 tablets orally (po) three times daily on days 1-5, for each of two menstrual cycles, Cycles 1 and 2. They will then be crossed over to Arm A, recombinant von Willebrand factor 40 IU/kg intravenously (IV) infusion on day 1 on each of two menstrual cycles, Cycles 3 and 4.