Prophylactic Tranexamic Acid During Minimally Invasive Myomectomies

Sponsor

Eastern Virginia Medical School (Other)

Overall Status

Recruiting

CT.gov ID

NCT04311073

Collaborator

(none)

Enrollment

Location

Arms

42.3

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fibroid Uterus Abnormal Uterine Bleeding Myoma;Uterus	Drug: Tranexamic Acid Drug: Placebos	Phase 3

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 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:

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. 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized Double Blind Placebo clinical trialRandomized Double Blind Placebo clinical trial

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 20, 2020

Anticipated Primary Completion Date :

Jul 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: Tranexamic Acid IV Tranexamic acid in 50 ml will be given 15 minutes prior to initial surgical incision in the placebo group.
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	Drug: Placebos IV normal saline 50 ml will be given 15 minutes prior to initial surgical incision in the placebo group.

Arm

Intervention/Treatment

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

Drug: Tranexamic Acid

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

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

Drug: Placebos

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

Outcome Measures

Primary Outcome Measures

Estimated blood loss [Duration of procedure up to 420 minutes]
Estimated blood loss at time of procedure completion; using volume of cannister and weight of lap sponges
Calculated blood loss [From post operative day 0 until postoperative day 1]
Calculated Blood loss, using pre-operative hematocrit, postoperative hematocrit and estimated blood volume x Body Mass Index
Number of blood products received [Duration of hospital stay up to two days]
Number of blood products received during admission that is directly due to blood loss at time of procedure

Secondary Outcome Measures

Duration of surgery [Duration of surgery up to 420 minutes]
Start time of procedure until end time of procedure
Length of hospital stay [Duration of stay in hospital, up to two days]
Recorded in days
Number of fibroids removed [Duration of surgery, up to 420 minutes]
Total number of fibroids removed during procedure
Fibroid type [through completion of study average 8 weeks]
type of fibroid per FIGO classification
Weight of fibroids removed [duration of surgery up to 420 minutes]
total weight of fibroids removed
Pain index [duration of hospital stay, up to two days]
Pain index score on postoperative day 1 and 14 Score of 0-10 0 = no pain, 10 = significant amount of pain
Incidence of postoperative complication [Duration of hospital stay , up to two days]
Immediate postoperative complication: Hemorrhage Infection Fever Deep vein thrombosis Hysterectomy Re-exploration Hospital readmission
Questionnaire for incidence of mild side effect of medication [only on postoperative day 1 , one day]
Reported mild effective of medication of post operative day 1
Questionnaire for incidence of serious side effect of medication [Only on postoperative day 1, one day]
Reported serious side effect of medication on post operative day 1
tPA receptor [From time of randomization until postoperative visit, four weeks]
Percentage of tPA receptor located in fibroid and myometrium
PAI-1 receptor [From time of randomization until postoeprative visit, four weeks]
Percentage of PAI-1receptor located in fibroid and myometrium

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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