Clinical trial: Minimize Menorrhagia in Women With Von Willebrand Disease (NCT02606045)

Eligibility criteria:
Inclusion Criteria:

          1. Adult females 13-45 years of age.

          2. Mild or moderate von Willebrand disease (VWF:RCo <0.50 IU/ml, normal multimers, past
             bleeding)

          3. Menorrhagia defined as PBAC >100 in at least one of the last two menstrual cycles.

          4. Regular menses, at least every 21-35 days.

          5. Willingness to have blood drawn

          6. No prior history of an allergic reaction or anaphylaxis to rVWF or TA.

          7. Willingness to avoid aspirin (ASA) and nonsteroidal anti-inflammatory agents (NSAIDS)
             during the study.

          8. Willingness to comply with randomization to rVWF or TA study arms.

          9. 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.

         10. 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.

         11. Willingness to use "double-barrier" method of contraception during the study.

        Exclusion Criteria:

          1. Any bleeding disorder other than von Willebrand disease; or past thrombotic disease

          2. Pregnant or lactating, or use of hormones (other than progesterone-only), or combined
             oral contraceptives, and contraceptive implants in past 3 months.

          3. Platelet count < 100,000/ul.

          4. Use of immunomodulatory or experimental drugs.

          5. Surgery within the past 8 weeks.

          6. Concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin or NSAIDs.

          7. Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives
             containing VWF within 5 days of study.

          8. Inability to comply with study requirements.

          9. Hypothyroidism as defined by elevated TSH.

         10. Iron deficiency as defined by low serum ferritin, unless iron replacement has been
             initiated.

         11. History of renal disease
Female
No healthy subjects accepted to join the trial.
Subject must be at least 13 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction.  Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration.  The patient has heavy menstrual cycles each month.  She has no other medical problems and takes no medications.  Her mother and grandmother have also had excessive bleeding during menstrual period.  Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL.

Patient description (patient's own words): I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels.

Does the patient match the trial criteria? Entailment