Prophylactic Tranexamic Acid During Minimally Invasive Myomectomies

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 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.

Conditions

Fibroid Uterus, Abnormal Uterine Bleeding, Myoma;Uterus

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Study Overview

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Study Details

Study overview

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.

Randomized Control Trial Investigating for Prophylactic Tranexamic Acid Use at Time of Minimally Invasive Myomectomies

Prophylactic Tranexamic Acid During Minimally Invasive Myomectomies

Condition
Fibroid Uterus
Intervention / Treatment

-

Contacts and Locations

Norfolk

EasternVMC, Norfolk, Virginia, United States, 23507

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Eastern Virginia Medical School,

Seifeldin Sadek, MD, PRINCIPAL_INVESTIGATOR, Eastern Virginia Medical School

Study Record Dates

2024-12-31