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Antifibrinolytic agent

Tranexamic Acid for Uterine Fibroids

Phase 3

Recruiting

Led By Seifeldin Sadek, MD

Research Sponsored by Eastern Virginia Medical School

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Any intramural or broad ligament fibroid greater than or equal to 4 cm

Undergoing laparoscopic myomectomy

Must not have

History of a prior blood clot in the lung arm or leg, known as pulmonary embolism or deep vein thrombosis

Concurrent oral contraceptive use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration of surgery up to 420 minutes

Awards & highlights

Pivotal Trial

Summary

This trial is testing whether or not the injection of TXA can reduce blood loss during surgery for uterine fibroids.

Who is the study for?

This trial is for women aged 18-45 with abnormal uterine bleeding due to fibroids, who are undergoing laparoscopic myomectomy. They must have at least one large fibroid or multiple smaller ones and no history of blood clots, stroke, severe organ issues, or certain medication use that could interfere with the study.

What is being tested?

The study tests if Tranexamic Acid (TXA) can reduce bleeding during minimally invasive surgery for uterine fibroids. Participants will either receive TXA or a placebo before surgery in this double-blinded trial where neither they nor the doctors know who gets which treatment.

What are the potential side effects?

Tranexamic Acid may cause side effects like nausea, diarrhea, muscle cramps, and risks related to clotting such as deep vein thrombosis. However, participants with known clotting risks are excluded from this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a fibroid that is 4 cm or larger.

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I am scheduled for a laparoscopic surgery to remove fibroids.

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I have a fibroid that is 6 cm or larger.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a blood clot in my lung, arm, or leg before.

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I am currently using oral contraceptives.

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I have no health issues preventing minimally invasive surgery for fibroids.

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I cannot take Tranexamic acid due to health reasons.

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I have a blood clotting disorder.

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My kidney function is impaired with a creatinine level over 1.4.

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I do not have any active blood clots or clotting diseases, and my kidney function is normal.

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I have had a stroke or mini-strokes in the past.

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I have severe heart, liver, or kidney problems.

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I currently have blood clots in my veins.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of randomization until postoperative visit, four weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from time of randomization until postoperative visit, four weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of randomization until postoperative visit, four weeks for reporting.