Peri-operative Aspirin Continuation Versus Discontinuation
NCT ID: NCT02350543
Last Updated: 2019-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
50 participants
INTERVENTIONAL
2015-02-28
2017-06-30
Brief Summary
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Detailed Description
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The risk associated with Aspirin withdrawal prior to surgery, including increased thrombogenicity, has been extensively studied. Following cessation of Aspirin, full platelet recovery is expected within 12-14 days, however, hemostasis may be regained with as little as 20% of normal platelet activity. Further, evidence supports a platelet rebound phenomenon in the setting of acute Aspirin withdrawal and a resultant clinical prothrombotic state, with thrombotic events peaking ten days following drug cessation. Finally, the acute stress response postoperatively is well known; one component being hypercoagulability which lasts at least seven days after major and uneventful abdominal surgery, predominantly caused by increased platelet activity.
Whereas TURBT generally carries a low overall risk of cardiac morbidity, the general requirement to discontinue Aspirin pre-operatively potentially increases certain patients' cerebrovascular or cardiac risk (eg. post-coronary stent placement). As shown above, the risk of significant post-operative hematuria is minimal, and as such, Aspirin withdrawal may be unnecessary. We will perform a prospective, randomized controlled trial to address the safety and tolerability of continued Aspirin use during TURBT.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Aspirin continuation
Continued use of Acetylsalicylic acid at prior dosage (75mg or 100mg tablet one-per-day).
Aspirin
Aspirin discontinuation
Discontinuation of Acetylsalicylic acid ten days prior to surgery, and re-initiation two weeks after hospital discharge.
No interventions assigned to this group
Interventions
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Aspirin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* referred for elective TURBT,
* receiving low-dose daily Aspirin prophylaxis.
Exclusion Criteria
* receiving other anti-thrombotic, anti-coagulant, or non-steroidal anti-inflammatory medication (NSAIDs),
* pregnancy.
18 Years
ALL
No
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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Marc Lubin
Dr.
Principal Investigators
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Marc A Lubin, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Urology, Rabin Medical Center
Locations
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Rabin Medical Center
Petah Tikva, , Israel
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Soni, A. Aspirin use among the adult U.S. non-institutionalized population, with and without indicators of heart disease, 2005. Statistical Brief #179. July 2007. Agency for Healthcare Research and Quality, Rockville, Md.
Other Identifiers
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RMC-13-0666
Identifier Type: -
Identifier Source: org_study_id
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