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Peri-operative Aspirin Continuation Versus Discontinuation

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ClinicalTrials.gov Identifier: NCT02350543
Recruitment Status : Terminated (Insufficient recruitment.)
First Posted : January 29, 2015
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Marc Lubin, Rabin Medical Center

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.

Condition or disease Intervention/treatment Phase
Hematuria Urinary Bladder Neoplasms Drug: Aspirin Phase 4

Detailed Description:

Recently, the American College of Chest Physicians in their 2012 clinical guidelines on perioperative anti-thrombotic therapy associated TUR of bladder tumour (TURBT) with an increased risk of bleeding associated with anti-thrombotic therapy. Despite this, contemporary series of TURBT identify the rate of significant in-hospital postoperative bleeding at only 2-3.4%. Previous prospective work by our group demonstrated no increase in postoperative hemorrhagic complications with early initiation of Aspirin following TURBT. These findings are supported by a recent retrospective work on TURBT showing a similar complication profile between continued perioperative antiplatelet therapy and antiplatelet naive patients.

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Must Aspirin be Discontinued Prior to TURBT: a Prospective, Randomized, Non-inferiority Trial Comparing Peri-operative Aspirin Continuation Versus Discontinuation.
Actual Study Start Date : February 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Active Comparator: Aspirin continuation
Continued use of Acetylsalicylic acid at prior dosage (75mg or 100mg tablet one-per-day).
Drug: Aspirin
Other Name: Acetylsalicylic acid

No Intervention: Aspirin discontinuation
Discontinuation of Acetylsalicylic acid ten days prior to surgery, and re-initiation two weeks after hospital discharge.



Primary Outcome Measures :
  1. Significant hematuria (composite endpoint) [ Time Frame: Post-operative admission period until 45 days post-discharge. ]
    (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.


Secondary Outcome Measures :
  1. Time to urinary catheter removal [ Time Frame: up to 45 days ]
    Measured in post-operative days, from the time of surgery until catheter removal (typically during post-operative admission period).

  2. Withholding or withdrawal of Aspirin [ Time Frame: up to 45 days ]
    A binary measure [0,1]. In the control group (Aspirin restarted two weeks post-discharge), if Aspirin is withheld due to continued hematuria, this will constitute an event. Similarly, in either group, if Aspirin is withdrawn at any point post-operatively due to hematuria, this will constitute an event.

  3. Time to urine clearance [ Time Frame: up to 45 days ]
    Measured in postoperative days until any lingering, sporadic macrohematuria has resolved. Patients will be discharged with a Hematuria Grading Scale based on that developed by Lee et al, a VAS-like scale of hematuria intensity (redness), and will note their most intense hematuria level on a daily basis until urine clearance. It is assumed that postoperative macrohematuria will resolve by 45 days postoperatively, the duration of followup.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02350543


Locations
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Israel
Rabin Medical Center
Petah Tikva, Israel
Sponsors and Collaborators
Rabin Medical Center
Investigators
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Principal Investigator: Marc A Lubin, MD Department of Urology, Rabin Medical Center

Additional Information:
Publications:
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. Erratum in: Circulation. 2006 Jun 6;113(22):e846.

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Responsible Party: Marc Lubin, Dr., Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02350543     History of Changes
Other Study ID Numbers: RMC-13-0666
First Posted: January 29, 2015    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019

Keywords provided by Marc Lubin, Rabin Medical Center:
Aspirin usage
Transurethral resection of bladder tumor (TURBT)

Additional relevant MeSH terms:
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Aspirin
Urinary Bladder Neoplasms
Hematuria
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Urination Disorders
Hemorrhage
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics