Clinical trial: Tranexamic Acid in Adolescents With Heavy Menstrual Bleeding (NCT01846507)

Eligibility criteria:
Inclusion Criteria:

          1. Menstruating females 10-19 years of age

          2. Non-smoker

          3. Physician and patient have agreed to initiate Lysteda

          4. Diagnosis of HMB based on the medical judgment of the principal or site investigator

          5. Subjects must report menstrual periods occurring within 21-60 days from the start of
             one period to the start of the next menstrual period

          6. Negative pregnancy test

          7. Informed consent obtained and signed

          8. Informed assent obtained and signed

          9. Understanding of study procedures

         10. Ability to comply with study procedures for the entire length of the study

         11. Subjects should be either sexually inactive (abstinent) or agree to use a barrier
             method with spermicide in the event of sexual activity throughout the study period

        Exclusion Criteria:

          1. Active thromboembolic disease, history of thromboembolic disease (including retinal
             vein or artery occlusion), known inherited thrombophilia, or family history of
             thrombosis in a first degree relative

          2. Subject has a severe medical or psychiatric illness that, in the opinion of the
             Investigator, would affect subject safety or compliance

          3. Clinical evidence of severe bleeding disorder. Patients with mild bleeding disorders
             such as type 1 von Willebrand disease, mild platelet function defects such as platelet
             storage pool or release defects, and patients with bleeding due to Ehlers Danlos
             syndrome WILL be eligible to participate in the study.

          4. Pregnancy within the past 6 months and/or breast-feeding

          5. Use of hormonal contraception (estrogen and progestin) within 3 months of study entry,
             or anticipated need to initiate estrogen-containing hormonal contraception during the
             study period

          6. Use of systemic steroids within 1 month of study entry

          7. History of subarachnoid hemorrhage

          8. History of Hepatitis B, C, or HIV

          9. Baseline creatinine >20% above the upper limit of normal for age

         10. Severe anemia (hemoglobin <8 g/dL)

         11. Systolic blood pressure <85 or diastolic blood pressure <55

         12. Heart rate <50 at time of screening

         13. Use of intranasal DDAVP during menses will be permitted, but only if the patient has a
             history of using DDAVP consistently for ≥3 menstrual cycles prior to study enrollment,
             so that change in menstrual blood loss due to addition of Lysteda can be assessed. Use
             of one-time DDAVP during a DDAVP/Stimate challenge is also permitted during the study
             period, as is use of DDAVP in the event of severe epistaxis, trauma, or surgical
             procedures during the study period.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 10 Years old.
Subject must be at most 19 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? Contradiction