Ovarian CancerNCT06879353
Comparison of Single-Dose Tranexamic Acid Vs. Placebo in Ovarian Cancer Surgery
A study testing Tranexamic Acid (TXA) in people with Ovarian Cancer and Perioperative Blood Loss, run by Sheikh Zayed Medical College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Ovarian Cancer, Perioperative Blood Loss, Blood Transfusion Events
- What is being tested?
- Tranexamic Acid (TXA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 372 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Jul 2023to 12 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60.
- Female gender.
- Ovarian cancer of > 12 months duration.
- FIGO stage I-III.
- American Society of Anesthesiologists (ASA) status 1-3.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sheikh Zayed Medical college/hospital
Rahim Yar Khan, Punjab Province, 66000
About this study
Official title: 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.
Read the 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.
- Being tested
- Tranexamic Acid (TXA), Placebo
- Keywords
- Ovarian Neoplasms, Tranexamic Acid, Perioperative Blood Loss, Gynecologic Oncology
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDrug
An equal volume of intravenous normal saline was administered as a placebo before surgery to compare outcomes with the tranexamic acid group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 12 hours after surgery
Secondary outcomes (1)
Perioperative Blood Loss
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.
Measured: During surgery and within 12 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start12 Jul 2023
- Primary completion12 Jul 2024
- Study completion12 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheikh Zayed Medical College
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kainat usman, Sheikh Zayed Medical College
- Investigators
- Kainat Usman, Principal investigator, Sheikh Zayed Medical college/Hospital, Rahimyar Khan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879353
- Sponsor's protocol ID
- Sheikh ZMC/H1
- Status last verified
- Mar 2025
- First submitted
- 11 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Single Dose Tranexamic Acid Versus Placebo Before Surgery in Females Undergoing Surgery for Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06879353
- Acronym / sponsor ID
- Sheikh ZMC/H1
- Keywords
- Ovarian Neoplasms, Tranexamic Acid, Perioperative Blood Loss, Gynecologic Oncology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- Sheikh Zayed Medical CollegeOther government
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Tranexamic Acid | Experimental | Drug: 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 comparator | Drug: PlaceboParticipants in this group received an equal volume of normal saline as a placebo intravenously before undergoing surgery for ovarian cancer. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-60.
- Female gender.
- Ovarian cancer of > 12 months duration.
- FIGO stage I-III.
- American Society of Anesthesiologists (ASA) status 1-3.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Group Tranexamic Acid |
| PlaceboAn equal volume of intravenous normal saline was administered as a placebo before surgery to compare outcomes with the tranexamic acid group. | Drug | Group Placebo |
Primary outcome
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.
1 secondary outcome
Perioperative Blood Loss
Time frame: During surgery and within 12 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kainat Usman principal investigator
Sheikh Zayed Medical college/Hospital, Rahimyar Khan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic Acid (TXA) in people with Ovarian Cancer and Perioperative Blood Loss, run by Sheikh Zayed Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Requirement of Blood Transfusion After Surgery (time frame: Within 12 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.