IV Tranexamic Acid Prior to Hysterectomy

• Status: Recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The objective of this study is to determine the effect of 1g of IV tranexamic acid given within 1 hour pre-operatively on intraoperative blood loss at time of hysterectomy.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Northwestern University
• Treatments: Tranexamic Acid

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