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

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.

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

• 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).