Clinical trial · Interventional
Peri-operative Aspirin Continuation Versus Discontinuation
Must Aspirin be Discontinued Prior to TURBT: a Prospective, Randomized, Non-inferiority Trial Comparing Peri-operative Aspirin Continuation Versus Discontinuation.
NCT02350543CI-TRIAL-00038000terminatedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Insufficient recruitment.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematuria | — | UNRESOLVED | — |
| Urinary Bladder Neoplasms | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aspirin | Drug | Aspirin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Aspirin continuation
- description
- Continued use of Acetylsalicylic acid at prior dosage (75mg or 100mg tablet one-per-day).
- interventionNames
- Drug: Aspirin
- type
- NO_INTERVENTION
- label
- Aspirin discontinuation
- description
- Discontinuation of Acetylsalicylic acid ten days prior to surgery, and re-initiation two weeks after hospital discharge.
Primary outcomes (1)
- measure
- Significant hematuria (composite endpoint)
- timeFrame
- Post-operative admission period until 45 days post-discharge.
- description
- (Composite endpoint): 1. Requiring bladder catheter drainage (after catheter removal), 2. requiring re-hospitalization, 3. requiring operative intervention (ie. cystoscopy +/- transurethral fulguration). Each sub-element within the composite endpoint will receive a binary score \[0,1\] to denote occurrence. Similarly, the primary endpoint is a binary measure indicating occurrence of any sub-element. Sub-elements 1-3 (re-cath, re-hospitalization, or cystoscopic intervention) may occur at any point throughout the followup period.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * adults aged 18 years and older with the ability for self-consent, * referred for elective TURBT, * receiving low-dose daily Aspirin prophylaxis. Exclusion Criteria: * known coagulopathy or abnormal coagulation profile (prothrombin time, partial thromboplastin time, or platelet count), * receiving other anti-thrombotic, anti-coagulant, or non-steroidal anti-inflammatory medication (NSAIDs), * pregnancy.
References
Publications (13)
- BACKGROUNDDouketis 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. PMID 22315266
- BACKGROUNDNieder 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. PMID 16280830
- BACKGROUNDCollado A, Chechile GE, Salvador J, Vicente J. Early complications of endoscopic treatment for superficial bladder tumors. J Urol. 2000 Nov;164(5):1529-32. PMID 11025697
- BACKGROUNDDe 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. PMID 24284200
- BACKGROUNDEhrlich 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. PMID 17570430
- BACKGROUNDPicozzi 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. PMID 24002913