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.
Drug: Tranexamic Acid
Drug: Sodium Chloride
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Full eligibility criteria for NCT02911831
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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.
Age ≥ 18 years
Pre-operative hemoglobin >8 g/dl
Willing to have IV tranexamic acid or a placebo prior to hysterectomy
Ability to understand and the willingness to sign a written informed consent.
Can be previously treated with Depo-Lupron, Depo-Provera, Oral Contraceptive pills, Mirena IUD, endometrial ablation, myomectomy, oral progestins
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
Patients with known or suspected endometrial/ovarian/cervical cancer.
Patients undergoing hysterectomy for endometrial hyperplasia or cervical dysplasia.
Patients currently undergoing treatment for any type of cancer.
Patients with known bleeding/clotting disorders or a history of thromboembolism
(including deep venous thrombosis or pulmonary embolism)
History of allergic reactions attributed to compounds of similar chemical or biologic composition to tranexamic acid.
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.
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.
Patients with acquired defective color vision
Patients with known renal failure and/or Cr > 5 within the last 6 months
All locations for NCT02911831
United States (1)
Northwestern University - Northwestern Medicine, Lavin Family Pavillion
Chicago, Illinois, United States, 60611
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View full eligibility
Tris trial is registered with FDA with number: NCT02911831. The sponsor of the trial is Northwestern University and it is looking for 248 volunteers for the current phase.
Official trial title: IV Tranexamic Acid Prior to Hysterectomy for Reduction of Intraoperative Blood Loss: A Randomized Placebo-Controlled Trial
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