Use of Intravenous Tranexamic Acid During Myomectomy (TA)

Use of Intravenous Tranexamic Acid During Myomectomy: A Randomized Double-Blind Placebo Controlled Trial

The purpose of this study is to determine the effect of the early administration of intravenous (IV) Tranexamic acid (TA) on perioperative bleeding (as defined by measured intraoperative estimated blood loss (EBL), change in pre and post-operative hemoglobin (Hb), and frequency of blood transfusions) in women undergoing a myomectomy.

Study Overview

• Status: Completed
• Conditions: Fibroids; Hemorrhage/Blood Loss During Myomectomies
• Intervention / Treatment: Drug: Tranexamic Acid; Other: Saline Solution

Detailed Description

Worldwide about 25% of women will develop uterine leiomyomas. Most myomas are asymptomatic however 20 to 25% of women with myomas develop symptoms, such as heavy menstrual bleeding, requiring treatment. For women failing medical management and desiring to preserve fertility and/or their uterus, surgical removal of fibroids (myomectomy) is the major option. Myomectomy is associated with both short and long-term complications, most significantly, hemorrhage and need for conversion to hysterectomy in 2% of cases, need for a blood transfusion in up to 20% of cases, prolonged postoperative stay, and can be potentially life-threatening. As such, various treatments have been suggested to decrease blood loss during myomectomy including pharmacologic manipulation of the coagulation cascade using agents such as tranexamic acid (TA). Despite the many described methods to reduce intraoperative bleeding, massive hemorrhage during myomectomy remains a significant challenge to gynecologic surgeons.

TA is a synthetic lysine derivative with antifibrinolytic activity that helps prevent clot break down. It is currently clinically used widely to stop heavy menstrual bleeding and many of the investigators' myomectomy patients are taking oral TA around the time of surgery. Systematic reviews of randomized control trials (RCTs) including over 25,000 patients of tranexamic acid in elective surgery showed that it reduced the risk of a blood transfusion by 34% (relative risk (RR) 0.61, 95% confidence interval (CI) 0.53 to 0.70) without an increased risk in venous thrombus embolus (VTE) or other adverse perioperative outcomes (Henry, 2011). Only one RCT has studied the use of TA during gynecologic surgery. This study was a randomized double blind placebo controlled trial of intravenous TA 10 mg/kg (maximum 1g) versus placebo during myomectomy procedures. Although there was a 63 ml decrease in postoperative blood loss (p<0.01), no significant difference was found between the two groups in terms of perioperative blood loss, change in hemoglobin, or rate of allogeneic blood transfusions. Further studies are needed with different dosing administration to confirm the true role of TA in the reduction of blood loss during myomectomy.

If a difference is seen, the results of future publications would directly impact clinical care locally and abroad, as few methods currently exist to prevent hemorrhage during myomectomy procedures.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Medical Faculty Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• women undergoing laparoscopic, robotic or abdominal myomectomy
• fibroid burden meeting the following criteria based on ultrasound imaging: Fibroids greater than or equal to 10 cm Intramural or Broad Ligament Fibroid greater than or equal to 6 cm Number of fibroids greater than or equal to 5 cm

Exclusion Criteria:

• Medical history of the following: thromboembolic disease, ischemic heart disease, malignancy, hematuria, liver disease, chronic kidney disease or subarachnoid hemorrhage
• pregnant women
• women who are nursing
• women with active thrombotic or thromboembolic disease
• women with history of intrinsic risk of thrombosis or thromboembolism
• hypersensitivity to Tranexamic Acid

Concurrent use of:

• combination of hormonal contraception
• factor IX complex concentrates
• Anti-inhibitor coagulant concentrates
• all-trans retinoic acid

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic Acid; This arm will receive an injection of Tranexamic Acid	Drug: Tranexamic Acid
Placebo Comparator: Saline; This arm will receive an injection of Saline Solution	Other: Saline Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Loss	the volume of blood loss will be measured at end of surgery.	At time of Surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
change in pre-operative and immediately post-operative hemoglobin	At time of Surgery
frequency of blood transfusions	At time of Surgery

Collaborators and Investigators

• Sponsor: George Washington University

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): February 22, 2018
• Study Completion (Actual): February 22, 2018

Study Registration Dates

• First Submitted: December 1, 2015
• First Submitted That Met QC Criteria: December 2, 2015
• First Posted (Estimate): December 3, 2015

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 091454