Phase 4
Completed N=100
Tranexamic Acid in Surgery of Advanced Ovarian Cancer
Source: ClinicalTrials.gov NCT00740116 ↗Enrolled (actual)
100
Serious AEs
24.0%
Results posted
Mar 2022
Primary outcomePrimary: Perioperative Bleeding Volume — 520; 730 milliliter — p=0.03
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of the study is to determine if a standardized single dose tranexamic acid given intravenously immediately preoperatively reduces the perioperative bleeding volume and reduces the need of blood transfusion in women undergoing surgery for advanced ovarian cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Perioperative Bleeding Volume |
520; 730 | 0.03 sig |
| SECONDARY Number of Patients Receiving Blood Transfusions |
15; 22 | 0.07 |
| SECONDARY Number of Units of Red Blood Cells (RBC) Transfused |
38; 53 | 0.46 |
| SECONDARY Median Number of Transfused Units of Red Blood Cells (RBC) |
2; 2 | 0.46 |
| SECONDARY Number of Patients With Clinically or Radiologically Verified Thromboembolic Events Within 5 Weeks Postoperatively |
2; 5 | 0.22 |
Eligibility Criteria
Inclusion Criteria
- Females ages 18 or older with a pelvic or abdominal tumor suspected or histopathologically proven ovarian cancer FIGO stage II-IV who are undergoing primary surgery with the intention of performing optimal cytoreductive radical surgery.
- Understand and speak Swedish
- Accept participation in the study after written and verbal information and sign informed consent.
Exclusion Criteria
- Allergy to tranexamic acid
- Having had tranexamic acid within the recent 30 days
- Previous or present episode of thromboembolic events .
- Previous or present treatment within the recent 3 months with anticoagulant.
- Previous or present known coagulopathy
- Myocardial infarction within the previous 12 months or instable angina pectoris which, according to the investigator, may increase the risk for complications significantly in case of a lowering of the hemoglobin.
- Significant renal failure with serum-creatinine > 250 µmol/l.
- Severe psychiatric dysfunction or mentally substantially disabled.
Data sourced from ClinicalTrials.gov (NCT00740116). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.