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Use of Intravenous Tranexamic Acid During Myomectomy (TA)

Primary Purpose

Hemorrhage/Blood Loss During Myomectomies, Fibroids

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tranexamic Acid
Saline Solution
Sponsored by
George Washington University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhage/Blood Loss During Myomectomies

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Medical Faculty Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tranexamic Acid

Saline

Arm Description

This arm will receive an injection of Tranexamic Acid

This arm will receive an injection of Saline Solution

Outcomes

Primary Outcome Measures

Blood Loss
the volume of blood loss will be measured at end of surgery.

Secondary Outcome Measures

change in pre-operative and immediately post-operative hemoglobin
frequency of blood transfusions

Full Information

First Posted
December 1, 2015
Last Updated
October 10, 2022
Sponsor
George Washington University
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1. Study Identification

Unique Protocol Identification Number
NCT02620748
Brief Title
Use of Intravenous Tranexamic Acid During Myomectomy
Acronym
TA
Official Title
Use of Intravenous Tranexamic Acid During Myomectomy: A Randomized Double-Blind Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
February 22, 2018 (Actual)
Study Completion Date
February 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
George Washington University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage/Blood Loss During Myomectomies, Fibroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic Acid
Arm Type
Experimental
Arm Description
This arm will receive an injection of Tranexamic Acid
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
This arm will receive an injection of Saline Solution
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Type
Other
Intervention Name(s)
Saline Solution
Primary Outcome Measure Information:
Title
Blood Loss
Description
the volume of blood loss will be measured at end of surgery.
Time Frame
At time of Surgery
Secondary Outcome Measure Information:
Title
change in pre-operative and immediately post-operative hemoglobin
Time Frame
At time of Surgery
Title
frequency of blood transfusions
Time Frame
At time of Surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States

12. IPD Sharing Statement

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Use of Intravenous Tranexamic Acid During Myomectomy

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