Tranexamic Acid's Effects in Patients Undergoing Laparoscopic Radical Prostatectomy

NCT05816668 | Unknown Phase 3

• 1 other identifier: NP2011/2021
• Study Type: interventional
• Target: 122
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Prostate Cancer

Keywords

prostate cancer; radical prostatectomy; video laparoscopic prostatectomy; tranexamic acid

Outcome Measures

Primary Outcomes (1)

• Change in serum Hemoglobin levels from preoperative to post operative levels

  The serum hemoglobin drop will be evaluated

  Baseline (Before) and 12 and 24 hours after surgery

Secondary Outcomes (3)

• Estimated volume of bleeding

  During surgery

• Transfusion rate of red blood cell concentrates

  12 and 24 hours after surgery

• Adverse effects tranexamic acid

  Up to 30 days after surgery

Study Arms (2)

Tranexamic Acid Group

EXPERIMENTAL

Patients will receive an attack solution of 1,0 g of tranexamic acid 20 minutes before the surgery beginning, followed by a maintence dose of 1,0 mg/kg/h in pump surgery infusion

Drug: Tranexamic acid

Placebo Group

PLACEBO COMPARATOR

Patients undergoinf to videolaparoscopic surgery will receive physcological saline as placebo under the same conditions of the tranexamic acid group.

Other: Placebo

Interventions

Tranexamic acid DRUG

Patients with prostate cancer and radical video laparoscopy prostatectomy indication will receive 1,0g of Tranexamic Acid solution IV in bolus 20 minutes before of anesthetic induction, followed by a maintenance hose of 1,0mg/kg/h of surgery.

Also known as: Transamin

Tranexamic Acid Group

Placebo OTHER

Patients randomized to placebo group will receive physiological saline and will undergo to the radical video laparoscopu prostatectomy normally

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients diagnosed with localized prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients over 18 years olds;
• Who accept to participate and sign the consent form;
• Compliance with the study follow-up protocol;
• Diagnosed with localized prostate cancer with surgical indication without or with lymphadenectomy.

You may not qualify if:

• Coronary artery disease treated with drug-using stent;
• Previous coronary procedures or coronary disease using a stent;
• Acute or chronic liver failure;
• Severe chronic renal failure (ClCr \< 30 mL/Kg.h, according to the Modification of Diet in Renal Disease formula);
• Suspected allergy to tranexamic acid;
• Known coagulopathies and refusal to sign consent form.

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead

Related Publications (33)

• 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.

  PMID: 33538338 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.

  PMID: 18027095 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.

  PMID: 28869989 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.

  PMID: 12124827 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.

  PMID: 30183466 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.

  PMID: 33172724 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.

  PMID: 2342176 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.

  PMID: 23127367 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.

  PMID: 29362896 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.

  PMID: 16442210 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.

  PMID: 28895658 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.

  PMID: 31085757 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.

  PMID: 12887468 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.

  PMID: 19185977 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.

  PMID: 20554319 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.

  PMID: 23694890 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.

  PMID: 26942474 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.

  PMID: 17966532 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.

  PMID: 18931201 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.

  PMID: 14167839 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.

  PMID: 14173416 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.

  PMID: 26080092 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.

  PMID: 23332883 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.

  PMID: 19418841 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.

  PMID: 19421755 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.

  PMID: 19281468 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.

  PMID: 15967256 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.

  PMID: 19443379 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.

  PMID: 33630393 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.

  PMID: 22012809 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.

  PMID: 33355078 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.

  PMID: 32753113 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.

  PMID: 19638912 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Rafael Ferreira Coelho, MD, PhD

  Instituto do Câncer do Estado de São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caio Brambilla, MD

CONTACT

+554499167029; caiobram@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Just ICESP's Clinical Research Pharmacy team will be not blinded. The surgical and anesthetic teams will be blinded in relation to the placebo or tranexamic acid intervention during the preoperative period and during the postoperative follow-up and, if any case loses the blinding, it will be excluded from the analysis. The preparation of packaging, dilution and dispensing or the material containing tranexamic acid or placebo will be carried out by the ICESP's Clinical Research Pharmacy division.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: April 18, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share