跳至主要内容
临床试验/NCT02350543
NCT02350543终止4 期

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

Rabin Medical Center1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
50
试验地点
1
主要终点
Significant hematuria (composite endpoint)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Aspirin continuation

Active Comparator

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

干预措施: Aspirin (Drug)

结局指标

主要结局

Significant hematuria (composite endpoint)

时间窗: 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.

次要结局

  • Time to urine clearance(up to 45 days)
  • Time to urinary catheter removal(up to 45 days)
  • Withholding or withdrawal of Aspirin(up to 45 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marc Lubin

Dr.

Rabin Medical Center

研究点 (1)

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