Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-25 @ 2:04 AM
NCT ID:
NCT04344860
Eligibility Criteria:
Inclusion Criteria:
1. Pregnant females \>= 18 years of age
2. Confirmed VWD, as defined by VWF:RCo \< 0.50 IU/dL and previous history of bleeding
3. Willingness to have blood drawn
4. Willing to be randomized to one of two treatments at delivery and for 2 days postpartum.
5. Willing to keep a diary for 3 weeks of postpartum bleeding by pictorial assessment chart (PBAC) and any blood products, transfusion, or medications taken.
6. Willing to return at 21 days for final blood draw and review of diary.
Exclusion Criteria:
1. Any bleeding disorder other than VWD; or past thrombotic disease of other bleeding disorders.
2. Previous thrombosis, cardiac disease, congestive failure, arrhythmia, hypertension, MI, or stroke.
3. Platelet count \< 100,000/ ul.
4. Past allergic reaction to VWF or tranexamic acid.
5. Surgery within the past 8 weeks.
6. Inability to comply with study protocol requirements.
7. Concomitant use of antiplatelet drugs, anticoagulants, or NSAIDs. Aspirin will be allowed for preeclampsia prevention.
8. Treatment with DDAVP, cryoprecipitate, whole blood, plasma or plasma derivatives containing substantial quantities of VWF within 5 days of study.
9. History of renal disease.
10. Inability to comply with study requirements.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04344860
Study Brief:
Protocol Section:
NCT04344860