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

Not Applicable

Completed

• Conditions: Ovarian Cancer; Perioperative Blood Loss; Blood Transfusion Events
• Interventions: Drug: Tranexamic Acid (TXA); Drug: Placebo

• Registration Number: NCT06879353
• Lead Sponsor: Sheikh Zayed Medical College

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.

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 Timeline

• Study Start: 2023-07-12
• Primary Completion: 2024-07-12
• Study Completion: 2024-07-12
• Status Verified: 2025-03
• Study First Submitted: 2025-03-11
• Study First Submitted QC: 2025-03-11
• Last Update Submitted: 2025-03-14
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 372

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Tranexamic Acid	Tranexamic Acid (TXA)	Participants in this group received a single preoperative intravenous dose of tranexamic acid at 15 mg/kg before undergoing surgery for ovarian cancer.
Group Placebo	Placebo	Participants in this group received an equal volume of normal saline as a placebo intravenously before undergoing surgery for ovarian cancer.

Primary Outcome Measures

Name	Time	Method
Requirement of Blood Transfusion After Surgery	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.

Secondary Outcome Measures

Name	Time	Method
Perioperative Blood Loss	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.

Trial Locations

Locations (1)

Sheikh Zayed Medical college/hospital; 🇵🇰 Rahim yar Khan, Punjab, Pakistan