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
|Condition or disease||Intervention/treatment||Phase|
|Hematuria Urinary Bladder Neoplasms||Drug: Aspirin||Phase 4|
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 (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: Aspirin continuation
Continued use of Acetylsalicylic acid at prior dosage (75mg or 100mg tablet one-per-day).
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.
- 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.
- 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).
- 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.
- 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.
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
|Rabin Medical Center|
|Petah Tikva, Israel|
|Principal Investigator:||Marc A Lubin, MD||Department of Urology, Rabin Medical Center|