UnknownPhase 3

Prophylactic Tranexamic Acid During Minimally Invasive Myomectomies

United States50 participantsStarted 2020-06-20

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Estimated blood loss

Timeframe: Duration of procedure up to 420 minutes

Calculated blood loss

Timeframe: From post operative day 0 until postoperative day 1

Number of blood products received

Timeframe: Duration of hospital stay up to two days

Trial details

NCT IDNCT04311073

SponsorEastern Virginia Medical School

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-30

Contact for this trial

Seifeldin Sadek, MD

7574467100 sadeks@evms.edu

View on ClinicalTrials.gov More Fibroid Uterus trials