Using Tranexamic Acid to Reduce Bleeding During Myomectomy
Randomized Control Trial Investigating for Prophylactic Tranexamic Acid Use at Time of Minimally Invasive Myomectomies
This study is testing if a medication called tranexamic acid can help reduce bleeding during surgery for women with fibroids who experience heavy periods.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Eastern Virginia Medical School Academic / other |
| Locations | 1 site (Norfolk, Virginia) |
| Trial ID | NCT04311073 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of tranexamic acid in reducing bleeding during minimally invasive myomectomies for women suffering from symptomatic fibroids. It is a double-blinded, randomized, placebo-controlled trial involving women aged 18-45 who have been diagnosed with menorrhagia or abnormal uterine bleeding due to uterine fibroids. Participants will receive either tranexamic acid or a placebo prior to surgery, with a total of 100 women enrolled in the study. The trial aims to assess the impact of tranexamic acid on surgical outcomes and bleeding control.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-45 with symptomatic fibroids requiring laparoscopic or robotic-assisted myomectomy.
Not a fit: Patients with severe medical complications, renal impairment, or contraindications to tranexamic acid will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce intraoperative bleeding, leading to improved surgical outcomes and recovery for patients.
How similar studies have performed: Previous studies have shown that tranexamic acid can effectively reduce bleeding in various surgical settings, suggesting potential success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Norfolk, Virginia
- EasternVMC — Norfolk, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Seifeldin Sadek, MD — Eastern Virginia Medical School
- Study coordinator: Seifeldin Sadek, MD
- Email: sadeks@evms.edu
- Phone: 7574467100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.