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Peri-operative Aspirin Continuation Versus Discontinuation

Primary Purpose

Hematuria, Urinary Bladder Neoplasms

Status
Terminated
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Aspirin
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematuria focused on measuring Aspirin usage, Transurethral resection of bladder tumor (TURBT)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rabin Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Aspirin continuation

Aspirin discontinuation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to urinary catheter removal
Measured in post-operative days, from the time of surgery until catheter removal (typically during post-operative admission period).
Withholding or withdrawal of Aspirin
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.
Time to urine clearance
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.

Full Information

First Posted
January 26, 2015
Last Updated
April 4, 2019
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02350543
Brief Title
Peri-operative Aspirin Continuation Versus Discontinuation
Official Title
Must Aspirin be Discontinued Prior to TURBT: a Prospective, Randomized, Non-inferiority Trial Comparing Peri-operative Aspirin Continuation Versus Discontinuation.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment.
Study Start Date
February 2015 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rabin Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematuria, Urinary Bladder Neoplasms
Keywords
Aspirin usage, Transurethral resection of bladder tumor (TURBT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aspirin continuation
Arm Type
Active Comparator
Arm Description
Continued use of Acetylsalicylic acid at prior dosage (75mg or 100mg tablet one-per-day).
Arm Title
Aspirin discontinuation
Arm Type
No Intervention
Arm Description
Discontinuation of Acetylsalicylic acid ten days prior to surgery, and re-initiation two weeks after hospital discharge.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Acetylsalicylic acid
Primary Outcome Measure Information:
Title
Significant hematuria (composite endpoint)
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.
Time Frame
Post-operative admission period until 45 days post-discharge.
Secondary Outcome Measure Information:
Title
Time to urinary catheter removal
Description
Measured in post-operative days, from the time of surgery until catheter removal (typically during post-operative admission period).
Time Frame
up to 45 days
Title
Withholding or withdrawal of Aspirin
Description
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.
Time Frame
up to 45 days
Title
Time to urine clearance
Description
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.
Time Frame
up to 45 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc A Lubin, MD
Organizational Affiliation
Department of Urology, Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center
City
Petah Tikva
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
22315266
Citation
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Results Reference
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Citation
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Citation
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Citation
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Citation
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Links:
URL
http://www.meps.ahrq.gov/mepsweb/data_files/publications/st179/stat179.pdf
Description
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.

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Peri-operative Aspirin Continuation Versus Discontinuation

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