Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2026-01-01 @ 4:51 PM
Study NCT ID:
NCT05816668
Status:
UNKNOWN
Last Update Posted:
2023-04-18
First Post:
2022-12-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tranexamic Acid's Effects in Patients Undergoing Laparoscopic Radical Prostatectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': "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."}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 122}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-17', 'studyFirstSubmitDate': '2022-12-22', 'studyFirstSubmitQcDate': '2023-04-17', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in serum Hemoglobin levels from preoperative to post operative levels', 'timeFrame': 'Baseline (Before) and 12 and 24 hours after surgery', 'description': 'The serum hemoglobin drop will be evaluated'}], 'secondaryOutcomes': [{'measure': 'Estimated volume of bleeding', 'timeFrame': 'During surgery', 'description': 'Total blood loss will be assessed by the volume aspirated during surgery.'}, {'measure': 'Transfusion rate of red blood cell concentrates', 'timeFrame': '12 and 24 hours after surgery', 'description': 'The amount of red blood cells concentrate transfused will be evaluated.'}, {'measure': 'Adverse effects tranexamic acid', 'timeFrame': 'Up to 30 days after surgery', 'description': 'The adverse effects tranexamic acid administration will be evaluated.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prostate cancer', 'radical prostatectomy', 'video laparoscopic prostatectomy', 'tranexamic acid'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '33538338', 'type': 'BACKGROUND', 'citation': 'Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. 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Ann Intern Med. 2017 Oct 3;167(7):449-455. doi: 10.7326/M16-2586. Epub 2017 Sep 5.'}, {'pmid': '12124827', 'type': 'BACKGROUND', 'citation': "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': '30183466', 'type': 'BACKGROUND', 'citation': '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. 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Epub 2018 Jan 23.'}, {'pmid': '16442210', 'type': 'BACKGROUND', 'citation': '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': '28895658', 'type': 'BACKGROUND', 'citation': '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. 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[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': '19421755', 'type': 'BACKGROUND', 'citation': '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': '19281468', 'type': 'BACKGROUND', 'citation': "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': '15967256', 'type': 'BACKGROUND', 'citation': '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': '19443379', 'type': 'BACKGROUND', 'citation': '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': '33630393', 'type': 'BACKGROUND', 'citation': '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': '22012809', 'type': 'BACKGROUND', 'citation': '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': '33355078', 'type': 'BACKGROUND', 'citation': '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': '32753113', 'type': 'BACKGROUND', 'citation': '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': '19638912', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "The study 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.\n\nTherefore it will be a randomized, placebo-controlled, double-blind clinical trial that intends to recruit 122 patients with radical prostatectomy indication who agreed to consent study inclusion.\n\nPatients randomized to intervention group will receive 1,0g of tranexamic acid IV during anesthetic induction, followed by a maintenance dose of 1,0 mg/kg/hour of surgery. Control group will be operated normally.\n\nData as hemoglobin drop, estimated bleeding volume, need to transfusion, side effects, and presence of lymphocele will be compared between the two groups."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Patients diagnosed with localized prostate cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years olds;\n* Who accept to participate and sign the consent form;\n* Compliance with the study follow-up protocol;\n* Diagnosed with localized prostate cancer with surgical indication without or with lymphadenectomy.\n\nExclusion Criteria:\n\n* Coronary artery disease treated with drug-using stent;\n* Previous coronary procedures or coronary disease using a stent;\n* Acute or chronic liver failure;\n* Severe chronic renal failure (ClCr \\< 30 mL/Kg.h, according to the Modification of Diet in Renal Disease formula);\n* Suspected allergy to tranexamic acid;\n* Known coagulopathies and refusal to sign consent form.'}, 'identificationModule': {'nctId': 'NCT05816668', 'acronym': 'Transamin', 'briefTitle': "Tranexamic Acid's Effects in Patients Undergoing Laparoscopic Radical Prostatectomy", 'organization': {'class': 'OTHER', 'fullName': 'Instituto do Cancer do Estado de São Paulo'}, 'officialTitle': "Tranexamic Acid's Effects in Patients Undergoing Laparoscopic Radical Prostatectomy: a Randomized, Double-blind, Placebo-controlled Trial", 'orgStudyIdInfo': {'id': 'NP2011/2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tranexamic Acid Group', 'description': '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', 'interventionNames': ['Drug: Tranexamic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Patients undergoinf to videolaparoscopic surgery will receive physcological saline as placebo under the same conditions of the tranexamic acid group.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Tranexamic acid', 'type': 'DRUG', 'otherNames': ['Transamin'], 'description': '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.', 'armGroupLabels': ['Tranexamic Acid Group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Patients randomized to placebo group will receive physiological saline and will undergo to the radical video laparoscopu prostatectomy normally', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Caio Brambilla, MD', 'role': 'CONTACT', 'email': 'caiobram@gmail.com', 'phone': '+554499167029'}], 'overallOfficials': [{'name': 'Rafael Ferreira Coelho, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto do Câncer do Estado de São Paulo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto do Cancer do Estado de São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'CAIO BRAMBILLA', 'investigatorAffiliation': 'Instituto do Cancer do Estado de São Paulo'}}}}