Prophylactic Tranexamic Acid During Minimally Invasive Myomectomies

Launched by EASTERN VIRGINIA MEDICAL SCHOOL · Mar 13, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called tranexamic acid (TXA) to help reduce bleeding during a specific type of surgery known as a laparoscopic or robotic-assisted myomectomy. This surgery is often performed on women who have fibroids—non-cancerous growths in the uterus—that can cause heavy bleeding and discomfort. The trial involves women aged 18 to 45 who have been diagnosed with these fibroids and are scheduled for surgery. Half of the participants will receive TXA just before their surgery, while the other half will receive a placebo, which is a harmless saline solution, so researchers can compare the effects.

To be eligible for this trial, participants must have at least one fibroid that is 6 cm or larger, or multiple smaller fibroids. However, certain health conditions, such as serious heart or kidney issues, or a history of blood clots, may disqualify someone from participating. If you join the study, you can expect a thorough evaluation and monitoring during your surgery, with the hope that the TXA will help reduce any excessive bleeding and improve your overall experience. The trial is currently recruiting participants, so if you or someone you know is interested, it may be worth discussing with a healthcare provider.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Undergoing laparoscopic myomectomy
• • At least one fibroid greater than or equal to 6 cm
• • Any intramural or broad ligament fibroid greater than or equal to 4 cm
• • At least 3 total fibroids based on preoperative imaging
• Exclusion Criteria:
• • Severe existing medical complications involving the heart, liver, or kidney
• • Moderate to severe renal impairment (serum creatinine \> 1.4)
• • Blood clotting abnormalities
• • Known Allergies to tranexamic acid
• • Known Contraindications to Minimally invasive myomectomies
• • If you are pregnant
• • History of a prior blood clot in the lung arm or leg, known as pulmonary embolism or deep vein thrombosis
• • Any active blood clots, clotting disease, pulmonary embolism, cerebral thrombosis, estrogen use, renal impairment, elevated creatinine level
• • History of a stroke or mini-strokes
• • Concurrent oral contraceptive use
• • Contraindications to receiving Tranexamic acid
• • In patients with acquired defective color vision, since this prohibits measuring one endpoint that should be followed as a measure of toxicity
• • In patients with subarachnoid hemorrhage. Anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by tranexamic acid in such patients.
• • In patients with active intravascular clotting.
• • In patients with hypersensitivity to tranexamic acid or any of the ingredients