Tranexamic Acid Infusion in Low Dose Versus in High Dose for Reducing Blood Loss in Radical Cystectomy Operations

Summary

Bladder cancer is one of the most common cancers of the genitourinary tract in adults, and its incidence distinctly increases with age . In almost two-thirds of cases, the disease is superficial at presentation and involves the mucosal and sub mucosal layers or the lamina propria of the bladder, whereas ∼20% to 30% of patients have muscle-invasive tumors. Superficial bladder cancer is treated by transurethral endoscopic resection, which can be followed by endovesical therapy for patients at risk of disease recurrence and progression . In contrast, muscle-invasive bladder cancer is generally treated by radical cystectomy with pelvic lymph node dissection and then creation of urinary diversion to create an alternate route for urine passage, which demonstrates 10-year recurrence-free survival rates of 50% to 59% and overall survival rates of ∼45% . These major surgeries have a prolonged operative times and are associated with significant risk of complications including high risk of perioperative bleeding and subsequent need for blood transfusion with significant postoperative complications, which are reportedly in the range of 24% to 64% .

Timeline

Start

2020-09

Primary completion

2021-09

Completion

2022-03

Publications

• Background van Rhijn BW, Burger M, Lotan Y, Solsona E, Stief CG, Sylvester RJ, Witjes JA, Zlotta AR. Recurrence and progression of disease in non-muscle-invasive bladder cancer: from epidemiology to treatment strategy. Eur Urol. 2009 Sep;56(3):430-42. doi: 10.1016/j.eururo.2009.06.028. Epub 2009 Jun 26.
• Background Parkin DM. The global burden of urinary bladder cancer. Scand J Urol Nephrol Suppl. 2008 Sep;(218):12-20. doi: 10.1080/03008880802285032.
• Background Thompson E. Urological oncology in Europe. Research highlights from the XVIIth congress of the European Association of Urology, Birmingham, UK, February 23-26, 2002. Drugs Today (Barc). 2002 Apr;38(4):221-34. No abstract available.
• Background Meyer JP, Blick C, Arumainayagam N, Hurley K, Gillatt D, Persad R, Fawcett D. A three-centre experience of orthotopic neobladder reconstruction after radical cystectomy: revisiting the initial experience, and results in 104 patients. BJU Int. 2009 Mar;103(5):680-3. doi: 10.1111/j.1464-410X.2008.08204.x. Epub 2008 Dec 2.
• Background Cookson MS, Chang SS, Wells N, Parekh DJ, Smith JA Jr. Complications of radical cystectomy for nonmuscle invasive disease: comparison with muscle invasive disease. J Urol. 2003 Jan;169(1):101-4. doi: 10.1016/S0022-5347(05)64045-1.
• Background Lawrentschuk N, Colombo R, Hakenberg OW, Lerner SP, Mansson W, Sagalowsky A, Wirth MP. Prevention and management of complications following radical cystectomy for bladder cancer. Eur Urol. 2010 Jun;57(6):983-1001. doi: 10.1016/j.eururo.2010.02.024. Epub 2010 Feb 26.
• Background Lowrance WT, Rumohr JA, Chang SS, Clark PE, Smith JA Jr, Cookson MS. Contemporary open radical cystectomy: analysis of perioperative outcomes. J Urol. 2008 Apr;179(4):1313-8; discussion 1318. doi: 10.1016/j.juro.2007.11.084. Epub 2008 Mar 4.
• Background Chang SS, Smith JA Jr, Wells N, Peterson M, Kovach B, Cookson MS. Estimated blood loss and transfusion requirements of radical cystectomy. J Urol. 2001 Dec;166(6):2151-4.
• Background Shabsigh A, Korets R, Vora KC, Brooks CM, Cronin AM, Savage C, Raj G, Bochner BH, Dalbagni G, Herr HW, Donat SM. Defining early morbidity of radical cystectomy for patients with bladder cancer using a standardized reporting methodology. Eur Urol. 2009 Jan;55(1):164-74. doi: 10.1016/j.eururo.2008.07.031. Epub 2008 Jul 18.
• Background Novara G, De Marco V, Aragona M, Boscolo-Berto R, Cavalleri S, Artibani W, Ficarra V. Complications and mortality after radical cystectomy for bladder transitional cell cancer. J Urol. 2009 Sep;182(3):914-21. doi: 10.1016/j.juro.2009.05.032. Epub 2009 Jul 17.
• Background Hautmann RE, de Petriconi RC, Volkmer BG. Lessons learned from 1,000 neobladders: the 90-day complication rate. J Urol. 2010 Sep;184(3):990-4; quiz 1235. doi: 10.1016/j.juro.2010.05.037.
• Background Quek ML, Stein JP, Daneshmand S, Miranda G, Thangathurai D, Roffey P, Skinner EC, Lieskovsky G, Skinner DG. A critical analysis of perioperative mortality from radical cystectomy. J Urol. 2006 Mar;175(3 Pt 1):886-9; discussion 889-90. doi: 10.1016/S0022-5347(05)00421-0.
• Background Clement C, Rossi P, Aissi K, Barthelemy P, Guibert N, Auquier P, Ragni E, Rossi D, Frances Y, Bastide C. Incidence, risk profile and morphological pattern of lower extremity venous thromboembolism after urological cancer surgery. J Urol. 2011 Dec;186(6):2293-7. doi: 10.1016/j.juro.2011.07.074. Epub 2011 Oct 20.
• Background Nilsson IM. Clinical pharmacology of aminocaproic and tranexamic acids. J Clin Pathol Suppl (R Coll Pathol). 1980;14:41-7. No abstract available.

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Indications