Clinical trial NCT06879353: Comparison of Single-Dose Tranexamic Acid Vs. Placebo in Ovarian Cancer Surgery
Official title: Comparison of Efficacy of Single Dose Tranexamic Acid Versus Placebo Before Surgery in Females Undergoing Surgery for Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer
Perioperative Blood Loss
Blood Transfusion Events
Keywords: Ovarian Neoplasms
Tranexamic Acid
Perioperative Blood Loss
Gynecologic Oncology
Lead sponsor: Sheikh Zayed Medical College
Sponsor class: OTHER_GOV
First posted: 2025-03-17
Enrollment: 372
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Requirement of Blood Transfusion After Surgery
timeFrame: Within 12 hours after surgery
Secondary outcomes:
measure: Perioperative Blood Loss
timeFrame: During surgery and within 12 hours postoperatively
Other outcomes:
Locations:
city: Rahim yar Khan
country: Pakistan
facility: Sheikh Zayed Medical college/hospital
state: Punjab
Study officials:
affiliation: Sheikh Zayed Medical college/Hospital, Rahimyar Khan
name: Kainat Usman
role: PRINCIPAL_INVESTIGATOR
References: