NCT02350543

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

2.3 years

First QC Date

January 26, 2015

Last Update Submit

April 4, 2019

Conditions

HematuriaUrinary Bladder Neoplasms

Keywords

Aspirin usageTransurethral resection of bladder tumor (TURBT)

Outcome Measures

Primary Outcomes (1)

  • Significant hematuria (composite endpoint)

    (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.

    Post-operative admission period until 45 days post-discharge.

Secondary Outcomes (3)

  • Time to urinary catheter removal

    up to 45 days

  • Withholding or withdrawal of Aspirin

    up to 45 days

  • Time to urine clearance

    up to 45 days

Study Arms (2)

Aspirin continuation

ACTIVE COMPARATOR

Continued use of Acetylsalicylic acid at prior dosage (75mg or 100mg tablet one-per-day).

Drug: Aspirin

Aspirin discontinuation

NO INTERVENTION

Discontinuation of Acetylsalicylic acid ten days prior to surgery, and re-initiation two weeks after hospital discharge.

Interventions

AspirinDRUG
Also known as: Acetylsalicylic acid
Aspirin continuation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults aged 18 years and older with the ability for self-consent,
  • referred for elective TURBT,
  • receiving low-dose daily Aspirin prophylaxis.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel

Location

Related Publications (13)

  • 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.

    PMID: 22315266BACKGROUND

  • 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.

    PMID: 16280830BACKGROUND

  • 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.

    PMID: 11025697BACKGROUND

  • 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.

    PMID: 24284200BACKGROUND

  • 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.

    PMID: 17570430BACKGROUND

  • 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.

    PMID: 24002913BACKGROUND

  • 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.

    PMID: 7045161BACKGROUND

  • 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.

    PMID: 7123514BACKGROUND

  • 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.

    PMID: 22470078BACKGROUND

  • 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.

    PMID: 17053008BACKGROUND

  • 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.

    PMID: 11226080BACKGROUND

  • 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.

    PMID: 11889023BACKGROUND

  • 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.

    PMID: 23896092BACKGROUND

Related Links

MeSH Terms

Conditions

HematuriaUrinary Bladder Neoplasms

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUrinary Bladder Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Marc A Lubin, MD

    Department of Urology, Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

January 26, 2015

First Posted

January 29, 2015

Study Start

February 1, 2015

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

April 8, 2019

Record last verified: 2019-04

Locations

IL(1)