Clinical trial: IV Tranexamic Acid Prior to Hysterectomy (NCT02911831)

Eligibility criteria:
Inclusion Criteria:

          1. Patients presenting for hysterectomy for any benign indication including but not
             limited to abnormal uterine bleeding, menorrhagia, uterine fibroids, adenomyosis,
             pelvic pain, dysmenorrhea, pelvic organ prolapse or endometriosis.

          2. Age ≥ 18 years

          3. Pre-operative hemoglobin >8 g/dl

          4. Willing to have IV tranexamic acid or a placebo prior to hysterectomy

          5. Ability to understand and the willingness to sign a written informed consent.

          6. Can be previously treated with Depo-Lupron, Depo-Provera, Oral Contraceptive pills,
             Mirena IUD, endometrial ablation, myomectomy, oral progestins

          7. Hysterectomy in combination with the following procedures is permitted:
             unilateral/bilateral salpingectomy or oophorectomy, ovarian cystectomy,
             fulguration/excision of endometriosis, appendectomy, sacrocolpopexy,
             anterior/posterior repair, uterosacral vault suspension, retropubic midurethral sling
             and cystoscopy

        Exclusion Criteria:

          1. Patients with known or suspected endometrial/ovarian/cervical cancer.

          2. Patients undergoing hysterectomy for endometrial hyperplasia or cervical dysplasia.

          3. Patients currently undergoing treatment for any type of cancer.

          4. Patients with known bleeding/clotting disorders or a history of thromboembolism
             (including deep venous thrombosis or pulmonary embolism)

          5. History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to tranexamic acid.

          6. Any procedures which occur in combination with other elective surgical procedures
             (such as abdominoplasty, breast augmentation, etc) which are not included in the
             previously mentioned inclusion criteria above will be excluded from data analysis.

          7. Uncontrolled current illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, subarachnoid hemorrhage, unstable
             angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that
             would limit compliance with study requirements.

          8. Patients with acquired defective color vision

          9. Patients with known renal failure and/or Cr > 5 within the last 6 months
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles.  The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days.  She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal.  On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis.

Patient description (patient's own words): I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis.

Does the patient match the trial criteria? Entailment