drugset / Trial / NCT00740116
Tranexamic Acid in Surgery of Advanced Ovarian Cancer
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2008-03
- Primary completion
- 2012-06
- Completion
- 2012-06
Publications
- Background Nielsen HJ. Detrimental effects of perioperative blood transfusion. Br J Surg. 1995 May;82(5):582-7. doi: 10.1002/bjs.1800820505.
- Background Lindoff 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.
- Background Dunn 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.
- Background Gai 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.
- Background Johansson 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.
- Background Abu-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.
- Background Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.
- Background Brecher 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.
- Background Johansson T, Lisander B, Ivarsson I. Mild hypothermia does not increase blood loss during total hip arthroplasty. Acta Anaesthesiol Scand. 1999 Nov;43(10):1005-10. doi: 10.1034/j.1399-6576.1999.431006.x.
- Background Zohar E, Fredman B, Ellis MH, Ifrach N, Stern A, Jedeikin R. A comparative study of the postoperative allogeneic blood-sparing effects of tranexamic acid and of desmopressin after total knee replacement. Transfusion. 2001 Oct;41(10):1285-9. doi: 10.1046/j.1537-2995.2001.41101285.x.
- Background Dolan S, Fitch M. The management of venous thromboembolism in cancer patients. Br J Nurs. 2007 Nov 22-Dec 12;16(21):1308-12. doi: 10.12968/bjon.2007.16.21.27715.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tranexamic Acid | Small molecule | 15 mg/kg | Intravenous |