Comparison of Single-Dose Tranexamic Acid Vs. Placebo in Ovarian Cancer Surgery

March 14, 2025 updated by: Kainat usman, Sheikh Zayed Medical College

Comparison of Efficacy of Single Dose Tranexamic Acid Versus Placebo Before Surgery in Females Undergoing Surgery for Ovarian Cancer

This study evaluated the effectiveness of a single dose of tranexamic acid compared to a placebo in reducing blood loss and the need for blood transfusions in women undergoing surgery for ovarian cancer. Tranexamic acid, a medication that helps control bleeding by stabilizing blood clots, has been widely used in other surgical settings but has not been well studied in ovarian cancer surgery.

Participants were randomly assigned to receive either a single dose of tranexamic acid or a placebo before surgery. Blood loss was measured during and after the procedure, and the need for blood transfusions was recorded. The study aimed to determine whether tranexamic acid was effective in reducing perioperative blood loss and minimizing the need for transfusions.

The findings contributed to understanding whether this cost-effective and widely available medication could improve surgical outcomes and reduce complications associated with excessive bleeding in ovarian cancer patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After obtaining approval from the ethical committee and CPSP and securing informed consent from the participants, all females who met the inclusion criteria were enrolled in the study from the outpatient department of OBGYN, Sheikh Zayed Medical College, Rahim Yar Khan. Their ASA status was assessed by a consultant anesthesiologist and documented by the researcher, along with their FIGO stage of cancer, which was determined by a consultant radiologist with a minimum of two years of experience. Patient demographics, including age, weight (measured by the researcher using a weighing scale), height (measured by the researcher using a wall-mounted height scale in meters), BMI (in kg/m²), duration of ovarian cancer, menstrual status (menstruating/menopausal), history of chemotherapy exposure, and prior abdomino-pelvic surgery (assessed by reviewing previous surgical records), were recorded.

Patients were then randomly divided into two groups using the paper lottery method:

Group (A) - Tranexamic Acid Group received a single preoperative dose of intravenous tranexamic acid at 15 mg/kg.

Group (B) - Placebo Group received an equal volume of normal saline. Patients were blinded to their group assignments. The surgery was performed by a consultant surgeon with at least three years of experience. Perioperative blood loss was calculated by the researcher as per the operational definition. Patients with post-operative hemoglobin levels below 9 g/dL, assessed through a CBC report obtained within 12 hours after surgery, were transfused with packed red blood cells.

Efficacy was assessed based on the requirement for transfusion after surgery, and it was labeled positive if no transfusion was needed. All data were documented using a self-designed proforma. Patient anonymity and confidentiality were maintained as a priority, with no personal identifiers such as patient names or contact details included in the documentation.

Study Type

Interventional

Enrollment (Actual)

372

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Rahim yar Khan, Punjab, Pakistan, 66000
        • Sheikh Zayed Medical college/hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-60.
  • Female gender.
  • Ovarian cancer of > 12 months duration.
  • FIGO stage I-III.
  • American Society of Anesthesiologists (ASA) status 1-3.

Exclusion Criteria:

  1. Ovarian cancer of FIGO stage IV
  2. ASA status 4-6.
  3. Hypersensitivity to tranexamic acid, (assessed by reviewing previous medical record).
  4. History of bleeding or clotting disorders (assessed by reviewing previous medical record).
  5. Impaired renal function (serum creatinine > 1.3 mg/dl).
  6. History of coronary heart disease (assessed by reviewing previous medical record).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group Tranexamic Acid
Participants in this group received a single preoperative intravenous dose of tranexamic acid at 15 mg/kg before undergoing surgery for ovarian cancer.
Drug: Tranexamic Acid (TXA)
A single intravenous dose of tranexamic acid (15 mg/kg) was administered before surgery to assess its efficacy in reducing perioperative blood loss and the need for transfusion.
Placebo Comparator: Group Placebo
Participants in this group received an equal volume of normal saline as a placebo intravenously before undergoing surgery for ovarian cancer.
Drug: Placebo
An equal volume of intravenous normal saline was administered as a placebo before surgery to compare outcomes with the tranexamic acid group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Requirement of Blood Transfusion After Surgery
Time Frame: Within 12 hours after surgery
The proportion of patients requiring a blood transfusion after surgery due to post-operative hemoglobin levels falling below 9 g/dL. Efficacy was defined as the absence of transfusion requirement postoperatively.
Within 12 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative Blood Loss
Time Frame: During surgery and within 12 hours postoperatively

Perioperative blood loss was calculated using the formula:

Perioperative Total Blood Loss (mL) = 1000 × (Preoperative Hemoglobin - Postoperative Hemoglobin) / Preoperative Hemoglobin The measurement provided an objective assessment of blood loss during and immediately after surgery.
During surgery and within 12 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheikh Zayed Medical College

Investigators

  • Principal Investigator: Kainat Usman, Sheikh Zayed Medical college/Hospital, Rahimyar Khan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2023

Primary Completion (Actual)

July 12, 2024

Study Completion (Actual)

July 12, 2024

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 14, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sheikh ZMC/H1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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