Clinical trial · Interventional
Tranexamic Acid in Surgery of Advanced Ovarian Cancer
Tranexamic Acid in Surgery of Advanced Ovarian Cancer - a Prospective Randomized Double Blind Placebo Controlled Study
NCT00740116CI-TRIAL-00057114completedPhase 4Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 0.9% NaCl solution | Drug | — | UNRESOLVED |
| Tranexamic acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- The Tranexamic acid group
- description
- The group of women receiving Tranexamic acid intravenously immediately before the surgery
- interventionNames
- Drug: Tranexamic acid
- type
- PLACEBO_COMPARATOR
- label
- The placebo group
- description
- The group of women receiving saline solution (0.9% NaCl) intravenously immediately before the surgery
- interventionNames
- Drug: 0.9% NaCl solution
Primary outcomes (1)
- measure
- Perioperative Bleeding Volume
- timeFrame
- From start of operation to discharge from hospital, up to 5 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (11)
- BACKGROUNDNielsen HJ. Detrimental effects of perioperative blood transfusion. Br J Surg. 1995 May;82(5):582-7. doi: 10.1002/bjs.1800820505. PMID 7613921
- BACKGROUNDLindoff C, Rybo G, Astedt B. Treatment with tranexamic acid during pregnancy, and the risk of thrombo-embolic complications. Thromb Haemost. 1993 Aug 2;70(2):238-40. PMID 8236125
- BACKGROUNDDunn CJ, Goa KL. Tranexamic acid: a review of its use in surgery and other indications. Drugs. 1999 Jun;57(6):1005-32. doi: 10.2165/00003495-199957060-00017. PMID 10400410
- BACKGROUNDGai MY, Wu LF, Su QF, Tatsumoto K. Clinical observation of blood loss reduced by tranexamic acid during and after caesarian section: a multi-center, randomized trial. Eur J Obstet Gynecol Reprod Biol. 2004 Feb 10;112(2):154-7. doi: 10.1016/s0301-2115(03)00287-2. PMID 14746950
- BACKGROUNDJohansson T, Pettersson LG, Lisander B. Tranexamic acid in total hip arthroplasty saves blood and money: a randomized, double-blind study in 100 patients. Acta Orthop. 2005 Jun;76(3):314-9. PMID 16156456
- BACKGROUNDAbu-Rustum NR, Richard S, Wilton A, Lev G, Sonoda Y, Hensley ML, Gemignani M, Barakat RR, Chi DS. Transfusion utilization during adnexal or peritoneal cancer surgery: effects on symptomatic venous thromboembolism and survival. Gynecol Oncol. 2005 Nov;99(2):320-6. doi: 10.1016/j.ygyno.2005.06.017. Epub 2005 Aug 2. PMID 16061278
- BACKGROUNDNadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available. PMID 21936146
- BACKGROUNDBrecher ME, Monk T, Goodnough LT. A standardized method for calculating blood loss. Transfusion. 1997 Oct;37(10):1070-4. doi: 10.1046/j.1537-2995.1997.371098016448.x.