Status:
UNKNOWN
Prophylactic Tranexamic Acid During Minimally Invasive Myomectomies
Lead Sponsor:
Eastern Virginia Medical School
Conditions:
Fibroid Uterus
Abnormal Uterine Bleeding
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief 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 t...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04311073
Start Date
June 20 2020
End Date
December 31 2024
Last Update
September 11 2023
Active Locations (1)
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1
EasternVMC
Norfolk, Virginia, United States, 23507