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

NCT06879353 | Completed DMC

• 1 other identifier: Sheikh ZMC/H1
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ovarian Cancer; Perioperative Blood Loss; Blood Transfusion Events

Keywords

Ovarian Neoplasms; Tranexamic Acid; Perioperative Blood Loss; Gynecologic Oncology

Outcome Measures

Primary Outcomes (1)

• Requirement of Blood Transfusion 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 Outcomes (1)

• Perioperative Blood Loss

  During surgery and within 12 hours postoperatively

Study Arms (2)

Group Tranexamic Acid

EXPERIMENTAL

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)

Group Placebo

PLACEBO COMPARATOR

Participants in this group received an equal volume of normal saline as a placebo intravenously before undergoing surgery for ovarian cancer.

Drug: Placebo

Interventions

Tranexamic Acid (TXA) DRUG

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.

Group Tranexamic Acid

Placebo DRUG

An equal volume of intravenous normal saline was administered as a placebo before surgery to compare outcomes with the tranexamic acid group.

Group Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: only Females
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sheikh Zayed Medical College: lead

Study Sites (1)

Sheikh Zayed Medical college/hospital

Rahim Yar Khan, Punjab Province, 66000, Pakistan

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Kainat Usman

  Sheikh Zayed Medical college/Hospital, Rahimyar Khan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 17, 2025
• Study Start: July 12, 2023
• Primary Completion: July 12, 2024
• Study Completion: July 12, 2024
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)