Tranexamic Acid's Effects in Patients Undergoing Laparoscopic Radical Prostatectomy

Summary

The study is randomized, placebo-controlled, double-blind clinical trial that aims to check whether tranexamic acid's use in videolaparoscopic radical prostatectomy intraoperative is effective in decrease serum hemoglobin drop and the amount of blood's transfusion.

Timeline

Start

2023-04

Primary completion

2024-04

Completion

2024-09

Publications

• Background Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
• Background Etzioni R, Tsodikov A, Mariotto A, Szabo A, Falcon S, Wegelin J, DiTommaso D, Karnofski K, Gulati R, Penson DF, Feuer E. Quantifying the role of PSA screening in the US prostate cancer mortality decline. Cancer Causes Control. 2008 Mar;19(2):175-81. doi: 10.1007/s10552-007-9083-8. Epub 2007 Nov 20.
• Background Tsodikov A, Gulati R, Heijnsdijk EAM, Pinsky PF, Moss SM, Qiu S, de Carvalho TM, Hugosson J, Berg CD, Auvinen A, Andriole GL, Roobol MJ, Crawford ED, Nelen V, Kwiatkowski M, Zappa M, Lujan M, Villers A, Feuer EJ, de Koning HJ, Mariotto AB, Etzioni R. Reconciling the Effects of Screening on Prostate Cancer Mortality in the ERSPC and PLCO Trials. Ann Intern Med. 2017 Oct 3;167(7):449-455. doi: 10.7326/M16-2586. Epub 2017 Sep 5.
• Background D'Amico AV, Whittington R, Malkowicz SB, Cote K, Loffredo M, Schultz D, Chen MH, Tomaszewski JE, Renshaw AA, Wein A, Richie JP. Biochemical outcome after radical prostatectomy or external beam radiation therapy for patients with clinically localized prostate carcinoma in the prostate specific antigen era. Cancer. 2002 Jul 15;95(2):281-6. doi: 10.1002/cncr.10657.
• Background Bekelman JE, Rumble RB, Chen RC, Pisansky TM, Finelli A, Feifer A, Nguyen PL, Loblaw DA, Tagawa ST, Gillessen S, Morgan TM, Liu G, Vapiwala N, Haluschak JJ, Stephenson A, Touijer K, Kungel T, Freedland SJ. Clinically Localized Prostate Cancer: ASCO Clinical Practice Guideline Endorsement of an American Urological Association/American Society for Radiation Oncology/Society of Urologic Oncology Guideline. J Clin Oncol. 2018 Nov 10;36(32):3251-3258. doi: 10.1200/JCO.18.00606. Epub 2018 Sep 5.
• Background Mottet N, van den Bergh RCN, Briers E, Van den Broeck T, Cumberbatch MG, De Santis M, Fanti S, Fossati N, Gandaglia G, Gillessen S, Grivas N, Grummet J, Henry AM, van der Kwast TH, Lam TB, Lardas M, Liew M, Mason MD, Moris L, Oprea-Lager DE, van der Poel HG, Rouviere O, Schoots IG, Tilki D, Wiegel T, Willemse PM, Cornford P. EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer-2020 Update. Part 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2021 Feb;79(2):243-262. doi: 10.1016/j.eururo.2020.09.042. Epub 2020 Nov 7.
• Background Rainwater LM, Segura JW. Technical consideration in radical retropubic prostatectomy: blood loss after ligation of dorsal venous complex. J Urol. 1990 Jun;143(6):1163-5. doi: 10.1016/s0022-5347(17)40215-1.
• Background Ramsay C, Pickard R, Robertson C, Close A, Vale L, Armstrong N, Barocas DA, Eden CG, Fraser C, Gurung T, Jenkinson D, Jia X, Lam TB, Mowatt G, Neal DE, Robinson MC, Royle J, Rushton SP, Sharma P, Shirley MD, Soomro N. Systematic review and economic modelling of the relative clinical benefit and cost-effectiveness of laparoscopic surgery and robotic surgery for removal of the prostate in men with localised prostate cancer. Health Technol Assess. 2012;16(41):1-313. doi: 10.3310/hta16410.
• Background Basiri A, de la Rosette JJ, Tabatabaei S, Woo HH, Laguna MP, Shemshaki H. Comparison of retropubic, laparoscopic and robotic radical prostatectomy: who is the winner? World J Urol. 2018 Apr;36(4):609-621. doi: 10.1007/s00345-018-2174-1. Epub 2018 Jan 23.
• Background Rassweiler J, Hruza M, Teber D, Su LM. Laparoscopic and robotic assisted radical prostatectomy--critical analysis of the results. Eur Urol. 2006 Apr;49(4):612-24. doi: 10.1016/j.eururo.2005.12.054. Epub 2006 Jan 18.
• Background Ilic D, Evans SM, Allan CA, Jung JH, Murphy D, Frydenberg M. Laparoscopic and robotic-assisted versus open radical prostatectomy for the treatment of localised prostate cancer. Cochrane Database Syst Rev. 2017 Sep 12;9(9):CD009625. doi: 10.1002/14651858.CD009625.pub2.
• Background Mohler JL, Antonarakis ES, Armstrong AJ, D'Amico AV, Davis BJ, Dorff T, Eastham JA, Enke CA, Farrington TA, Higano CS, Horwitz EM, Hurwitz M, Ippolito JE, Kane CJ, Kuettel MR, Lang JM, McKenney J, Netto G, Penson DF, Plimack ER, Pow-Sang JM, Pugh TJ, Richey S, Roach M, Rosenfeld S, Schaeffer E, Shabsigh A, Small EJ, Spratt DE, Srinivas S, Tward J, Shead DA, Freedman-Cass DA. Prostate Cancer, Version 2.2019, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2019 May 1;17(5):479-505. doi: 10.6004/jnccn.2019.0023.
• Background Tewari A, Srivasatava A, Menon M; Members of the VIP Team. A prospective comparison of radical retropubic and robot-assisted prostatectomy: experience in one institution. BJU Int. 2003 Aug;92(3):205-10. doi: 10.1046/j.1464-410x.2003.04311.x.
• Background Ficarra V, Novara G, Artibani W, Cestari A, Galfano A, Graefen M, Guazzoni G, Guillonneau B, Menon M, Montorsi F, Patel V, Rassweiler J, Van Poppel H. Retropubic, laparoscopic, and robot-assisted radical prostatectomy: a systematic review and cumulative analysis of comparative studies. Eur Urol. 2009 May;55(5):1037-63. doi: 10.1016/j.eururo.2009.01.036. Epub 2009 Jan 25.
• Background CRASH-2 trial collaborators; Shakur H, Roberts I, Bautista R, Caballero J, Coats T, Dewan Y, El-Sayed H, Gogichaishvili T, Gupta S, Herrera J, Hunt B, Iribhogbe P, Izurieta M, Khamis H, Komolafe E, Marrero MA, Mejia-Mantilla J, Miranda J, Morales C, Olaomi O, Olldashi F, Perel P, Peto R, Ramana PV, Ravi RR, Yutthakasemsunt S. Effects of tranexamic acid on death, vascular occlusive events, and blood transfusion in trauma patients with significant haemorrhage (CRASH-2): a randomised, placebo-controlled trial. Lancet. 2010 Jul 3;376(9734):23-32. doi: 10.1016/S0140-6736(10)60835-5. Epub 2010 Jun 14.
• Background Napolitano LM, Cohen MJ, Cotton BA, Schreiber MA, Moore EE. Tranexamic acid in trauma: how should we use it? J Trauma Acute Care Surg. 2013 Jun;74(6):1575-86. doi: 10.1097/TA.0b013e318292cc54. No abstract available.
• Background Lin ZX, Woolf SK. Safety, Efficacy, and Cost-effectiveness of Tranexamic Acid in Orthopedic Surgery. Orthopedics. 2016 Mar-Apr;39(2):119-30. doi: 10.3928/01477447-20160301-05. Epub 2016 Mar 4.
• Background Claeys MA, Vermeersch N, Haentjens P. Reduction of blood loss with tranexamic acid in primary total hip replacement surgery. Acta Chir Belg. 2007 Jul-Aug;107(4):397-401. doi: 10.1080/00015458.2007.11680081.
• Background Dietrich W, Spannagl M, Boehm J, Hauner K, Braun S, Schuster T, Busley R. Tranexamic acid and aprotinin in primary cardiac operations: an analysis of 220 cardiac surgical patients treated with tranexamic acid or aprotinin. Anesth Analg. 2008 Nov;107(5):1469-78. doi: 10.1213/ane.0b013e318182252b.
• Background MACFARLANE RG. AN ENZYME CASCADE IN THE BLOOD CLOTTING MECHANISM, AND ITS FUNCTION AS A BIOCHEMICAL AMPLIFIER. Nature. 1964 May 2;202:498-9. doi: 10.1038/202498a0. No abstract available.
• Background DAVIE EW, RATNOFF OD. WATERFALL SEQUENCE FOR INTRINSIC BLOOD CLOTTING. Science. 1964 Sep 18;145(3638):1310-2. doi: 10.1126/science.145.3638.1310.
• Background Wang YL, Jiang B, Yin FF, Shi HQ, Xu XD, Zheng SS, Wu S, Hou SC. Perioperative Blood Transfusion Promotes Worse Outcomes of Bladder Cancer after Radical Cystectomy: A Systematic Review and Meta-Analysis. PLoS One. 2015 Jun 16;10(6):e0130122. doi: 10.1371/journal.pone.0130122. eCollection 2015.
• Background Linder BJ, Frank I, Cheville JC, Tollefson MK, Thompson RH, Tarrell RF, Thapa P, Boorjian SA. The impact of perioperative blood transfusion on cancer recurrence and survival following radical cystectomy. Eur Urol. 2013 May;63(5):839-45. doi: 10.1016/j.eururo.2013.01.004. Epub 2013 Jan 11.
• Background Kerkebe Lama M, Orellana Salinas NR, Flores Martinez JM, Olivares Gribbell RA, Storme Cabrera O, Fuentealba Sudy CA. [Prospective study and comparative of surgical and oncologic outcome between laparoscopic and retropubical radical prostatectomy]. Actas Urol Esp. 2009 Feb;33(2):167-71. doi: 10.1016/s0210-4806(09)74118-x. Spanish.
• Background Drouin SJ, Vaessen C, Hupertan V, Comperat E, Misrai V, Haertig A, Bitker MO, Chartier-Kastler E, Richard F, Roupret M. Comparison of mid-term carcinologic control obtained after open, laparoscopic, and robot-assisted radical prostatectomy for localized prostate cancer. World J Urol. 2009 Oct;27(5):599-605. doi: 10.1007/s00345-009-0379-z. Epub 2009 May 7.
• Background Ficarra V, Novara G, Fracalanza S, D'Elia C, Secco S, Iafrate M, Cavalleri S, Artibani W. A prospective, non-randomized trial comparing robot-assisted laparoscopic and retropubic radical prostatectomy in one European institution. BJU Int. 2009 Aug;104(4):534-9. doi: 10.1111/j.1464-410X.2009.08419.x. Epub 2009 Mar 5.
• Background Remzi M, Klingler HC, Tinzl MV, Fong YK, Lodde M, Kiss B, Marberger M. Morbidity of laparoscopic extraperitoneal versus transperitoneal radical prostatectomy verus open retropubic radical prostatectomy. Eur Urol. 2005 Jul;48(1):83-9; discussion 89. doi: 10.1016/j.eururo.2005.03.026. Epub 2005 Apr 12.
• Background Ou YC, Yang CR, Wang J, Cheng CL, Patel VR. Comparison of robotic-assisted versus retropubic radical prostatectomy performed by a single surgeon. Anticancer Res. 2009 May;29(5):1637-42.
• Background Batagello CA, Vicentini FC, Monga M, Miller AW, Marchini GS, Torricelli FCM, Danilovic A, Coelho RF, Srougi M, Nahas WC, Mazzucchi E. Tranexamic acid in patients with complex stones undergoing percutaneous nephrolithotomy: a randomised, double-blinded, placebo-controlled trial. BJU Int. 2022 Jan;129(1):35-47. doi: 10.1111/bju.15378. Epub 2021 Jun 13.
• Background Crescenti A, Borghi G, Bignami E, Bertarelli G, Landoni G, Casiraghi GM, Briganti A, Montorsi F, Rigatti P, Zangrillo A. Intraoperative use of tranexamic acid to reduce transfusion rate in patients undergoing radical retropubic prostatectomy: double blind, randomised, placebo controlled trial. BMJ. 2011 Oct 19;343:d5701. doi: 10.1136/bmj.d5701.
• Background Balik M, Kosina J, Husek P, Brodak M, Cecka F. Safety and Efficacy of Using Tranexamic Acid at the Beginning of Robotic-Assisted Radical Prostatectomy in a Double-Blind Prospective Randomized Pilot Study. Acta Medica (Hradec Kralove). 2020;63(4):176-182. doi: 10.14712/18059694.2020.60.
• Background Saravanan R, Venkatraman R, Karthik K, Pushparani A. [Efficacy of different doses and timing of tranexamic acid in major orthopedic surgeries: a randomized trial]. Braz J Anesthesiol. 2020 Jul-Aug;70(4):311-317. doi: 10.1016/j.bjan.2020.03.013. Epub 2020 Jul 8.
• Background Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

Drugs

Indications