Prophylactic Tranexamic Acid During Minimally Invasive Myomectomies

Eastern Virginia Medical School (EVMS)

Status and phase: Enrolling; Phase 3

Conditions: Fibroid Uterus; Myoma;Uterus; Abnormal Uterine Bleeding

Treatments: Drug: Placebos; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT04311073

19-08-FB-0189

Details and patient eligibility

About

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.

Full 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. These subjects will be then approached for consent during their pre-op visit 1-2 weeks prior to their surgery. The setting for consent will be in a patient consultation room. A total of 50 women in each arm of the study with symptomatic fibroids meeting any of the following criteria will be included in the study:

1. At least one fibroid greater than or equal to 6 cm
2. Any intramural or broad ligament fibroid greater than or equal to 4 cm
3. At least 3 total fibroids based on preoperative imaging. Randomization will be performed using an automated randomization website 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. This dosage will not be adjusted for patients with renal insufficiency as they will be excluded from the study. Preparation of the medications will be performed by anesthesia who have both medication and normal saline available to them on short notice. No prior preparation by pharmacy will be required. Tranexamic acid is readily available in a 10 ml vial, which does not need a pharmacist to prepare for administration. The vial is mixed with 50 ml of saline in the operating room. This is the same process that occurs outside of any study with any medication that is administered intra-operatively. This will in no way impact the patient's safety during the surgery, especially since it is administered 15 minutes prior to the start of the procedure.

Both surgeon and patient will be blinded to the treatment arm. This dosage has been used previously in both obstetric and gynecological procedures and is the same dose recommended by the WHO for preventing post-partum hemorrhage The surgery itself will be scheduled at either Sentara Norfolk General, Sentara Leigh hospital, and Sentara Princess Anne hospital. These are the three sites that the investigators already perform Minimally invasive myomectomies.

An envelope will be given to the anesthesiologist prior to the procedure informing whether they are to receives TXA or the placebo. Blood loss will be estimated by the surgeon performing the procedure. Hemoglobin and hematocrit will be obtained 24 hours post procedure. The patient will be assessed for reported side effects from the medication given will be assessed by a questionnaire that will be given at their post-op appointment at the 2 week and 6-week mark. During these two visits a physical exam is performed, checking incision sites, and patient symptoms, all of which are standard of care for any minimally invasive procedure. The patients will be seen at the EVMS outpatient clinic for Gynecology, or depending with the physician who performed the surgery. Data will be collected from both Allscripts and EPIC charts.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Tranexamic Acid

Experimental group

Description:

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

Treatment:

Drug: Tranexamic Acid

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebos