Peri-operative Aspirin Continuation Versus Discontinuation

April 4, 2019 updated by: Marc Lubin, Rabin Medical Center

Must Aspirin be Discontinued Prior to TURBT: a Prospective, Randomized, Non-inferiority Trial Comparing Peri-operative Aspirin Continuation Versus Discontinuation.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petah Tikva, Israel
        • Rabin Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post-operative admission period until 45 days post-discharge.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
up to 45 days
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.
up to 45 days
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.
up to 45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Investigators

  • Principal Investigator: Marc A Lubin, MD, Department of Urology, Rabin Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

January 26, 2015

First Submitted That Met QC Criteria

January 28, 2015

First Posted (Estimate)

January 29, 2015

Study Record Updates

Last Update Posted (Actual)

April 8, 2019

Last Update Submitted That Met QC Criteria

April 4, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RMC-13-0666

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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