Recruiting
Phase 3

Tranexamic Acid

Sponsor:

Eastern Virginia Medical School

Code:

NCT04311073

Conditions

Fibroid Uterus

Abnormal Uterine Bleeding

Myoma;Uterus

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Tranexamic Acid

Placebos

Study Details

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 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

Study ID

NCT04311073

Start date

Jun 20, 2020

Status verified date

Sep, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Jul 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Tranexamic Acid

Patients will receive a single IV bolus injection of TXA 30mg/kg in 50ml of normal saline 15 minutes prior to initial surgical incision time

placebo comparator: Placebo

Patients will receive an IV bolus injection of normal saline of equivalent volume (placebo group) 15 minutes prior to initial surgical incision

Interventions

Tranexamic Acid

IV Tranexamic acid in 50 ml will be given 15 minutes prior to initial surgical incision in the placebo group.

Placebos

IV normal saline 50 ml will be given 15 minutes prior to initial surgical incision in the placebo group.

Primary outcome measure

  • Estimated blood loss [ Time Frame: Duration of procedure up to 420 minutes ]
  • Calculated blood loss [ Time Frame: From post operative day 0 until postoperative day 1 ]
  • Number of blood products received [ Time Frame: Duration of hospital stay up to two days ]

Central Contacts and Locations

Central contacts

Seifeldin Sadek, MD

7574467100sadeks@evms.edu

Traci Ito, MD

7574467900itoTE@evms.edu

Locations

EasternVMC

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Seifeldin Sadek, MD

757-446-7100sadeks@evms.edu

Traci Ito, MD

7574467900itoTE@evms.edu

More Information

Sponsor

Eastern Virginia Medical School

Last update posted

Sep 11, 2023

Last verified

Sep, 2023

Keywords

  • Tranexamic acid
  • Minimally Invasive
  • Myomectomy
  • Fibroid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eastern Virginia Medical School on 2023-09-11.