drugset / Trial / NCT02350543
Peri-operative Aspirin Continuation Versus Discontinuation
RandomizedParallel-groupOpen-labelTreatment
Summary
This study evaluates the continuation (non-discontinuation) of Aspirin during TURBT. Half of participants will continue their usual low-dose Aspirin regimen during TURBT and throughout the perioperative period, while the other half will discontinue Aspirin use ten days prior to surgery (standard recommendation) and restart therapy two weeks post-discharge.
Timeline
- Start
- 2015-02
- Primary completion
- 2017-06
- Completion
- 2017-06
Outcome
Outcome not reported
Stopped (Enrollment): “Insufficient recruitment.”
Publications
- Background Douketis JD, Spyropoulos AC, Spencer FA, Mayr M, Jaffer AK, Eckman MH, Dunn AS, Kunz R. Perioperative management of antithrombotic therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e326S-e350S. doi: 10.1378/chest.11-2298.
- Background Nieder AM, Meinbach DS, Kim SS, Soloway MS. Transurethral bladder tumor resection: intraoperative and postoperative complications in a residency setting. J Urol. 2005 Dec;174(6):2307-9. doi: 10.1097/01.ju.0000181797.19395.03.
- Background Collado A, Chechile GE, Salvador J, Vicente J. Early complications of endoscopic treatment for superficial bladder tumors. J Urol. 2000 Nov;164(5):1529-32.
- Background De Nunzio C, Franco G, Cindolo L, Autorino R, Cicione A, Perdona S, Falsaperla M, Gacci M, Leonardo C, Damiano R, De Sio M, Tubaro A. Transuretral resection of the bladder (TURB): analysis of complications using a modified Clavien system in an Italian real life cohort. Eur J Surg Oncol. 2014 Jan;40(1):90-5. doi: 10.1016/j.ejso.2013.11.003. Epub 2013 Nov 12.
- Background Ehrlich Y, Yossepowitch O, Margel D, Lask D, Livne PM, Baniel J. Early initiation of aspirin after prostate and transurethral bladder surgeries is not associated with increased incidence of postoperative bleeding: a prospective, randomized trial. J Urol. 2007 Aug;178(2):524-8; discussion 528. doi: 10.1016/j.juro.2007.03.134. Epub 2007 Jun 14.
- Background Picozzi S, Marenghi C, Ricci C, Bozzini G, Casellato S, Carmignani L. Risks and complications of transurethral resection of bladder tumor among patients taking antiplatelet agents for cardiovascular disease. Surg Endosc. 2014 Jan;28(1):116-21. doi: 10.1007/s00464-013-3136-8. Epub 2013 Sep 4.
- Background Patrignani P, Filabozzi P, Patrono C. Selective cumulative inhibition of platelet thromboxane production by low-dose aspirin in healthy subjects. J Clin Invest. 1982 Jun;69(6):1366-72. doi: 10.1172/jci110576.
- Background Bradlow BA, Chetty N. Dosage frequency for suppression of platelet function by low dose aspirin therapy. Thromb Res. 1982 Jul 1;27(1):99-110. doi: 10.1016/0049-3848(82)90283-3.
- Background Gerstein NS, Schulman PM, Gerstein WH, Petersen TR, Tawil I. Should more patients continue aspirin therapy perioperatively?: clinical impact of aspirin withdrawal syndrome. Ann Surg. 2012 May;255(5):811-9. doi: 10.1097/SLA.0b013e318250504e.
- Background Biondi-Zoccai GG, Lotrionte M, Agostoni P, Abbate A, Fusaro M, Burzotta F, Testa L, Sheiban I, Sangiorgi G. A systematic review and meta-analysis on the hazards of discontinuing or not adhering to aspirin among 50,279 patients at risk for coronary artery disease. Eur Heart J. 2006 Nov;27(22):2667-74. doi: 10.1093/eurheartj/ehl334. Epub 2006 Oct 19.
- Background Mahla E, Lang T, Vicenzi MN, Werkgartner G, Maier R, Probst C, Metzler H. Thromboelastography for monitoring prolonged hypercoagulability after major abdominal surgery. Anesth Analg. 2001 Mar;92(3):572-7. doi: 10.1097/00000539-200103000-00004.
- Background Eagle KA, Berger PB, Calkins H, Chaitman BR, Ewy GA, Fleischmann KE, Fleisher LA, Froehlich JB, Gusberg RJ, Leppo JA, Ryan T, Schlant RC, Winters WL Jr, Gibbons RJ, Antman EM, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Jacobs AK, Hiratzka LF, Russell RO, Smith SC Jr; American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1996 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery). ACC/AHA guideline update for perioperative cardiovascular evaluation for noncardiac surgery---executive summary a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Update the 1996 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery). Circulation. 2002 Mar 12;105(10):1257-67. No abstract available.
- Background Lee JY, Chang JS, Koo KC, Lee SW, Choi YD, Cho KS. Hematuria grading scale: a new tool for gross hematuria. Urology. 2013 Aug;82(2):284-9. doi: 10.1016/j.urology.2013.04.048.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aspirin | Small molecule | 75 mg | — |
| Comparator | Aspirin | Small molecule | 100 mg | — |