Prophylactic Tranexamic Acid During Minimally Invasive Myomectomies

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: Female

Summary

This is a Double-blinded randomized placebo-controlled trial based at Eastern Virginia Medical School. Subjects who are identified in clinic having menorrhagia or abnormal Uterine bleeding (AUB) due to uterine fibroids and meet inclusion criteria based on the ultrasound (US) or Magnetic Resonance Imaging (MRI), aged 18-45 undergoing laparoscopic or Robotic assisted myomectomies. A total of 50 women in each arm of the study with symptomatic fibroids. Patients will be randomized to receive a single IV bolus injection of TXA 30mg/kg in 50ml of normal saline (intervention group) versus an IV bolus injection of normal saline of equivalent volume (placebo group) 15 minutes prior to initial surgical incision.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eastern Virginia Medical School
• Treatments: Tranexamic Acid

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