Continuing Low Dose Aspirin Before Prostate Biopsy
To Investigate Post-procedure Hemorrhage and Cardiovascular Events in Taiwanese Patients Who Continue or Discontinue Low-Dose Aspirin Before Transrectal Prostate Biopsy: a Prospective Randomized Trial
Objectives: To determine whether TRUS-guided prostate biopsy performed in patients continuing low-dose aspirin (LDA) is associated with a greater incidence, duration, and severity of bleeding complications.
Eligibility: Men over 40-year-old with an elevated serum prostate-specific antigen level and/or abnormal digital rectal examination findings are candidates for PB.
Design of trial Prospective Randomized Trial Study treatment: Continuing low-Dose aspirin before transrectal prostate biopsy Primary endpoint: The incidence, duration, and severity of bleeding complications Statistical analysis and sample size estimation: Fisher's exact test or chi-square test will be used to explore the differences between two groups for categorical variables, and Student t-test will be used for continuous variables. Under the assumption of a difference of 25% of bleeding complications in each group, with α=0.05 and power=0.80, 60 subject are needed in each arm. Assuming the drop-out rate to be 20%, the targeted recruit number is 150 in total.
調査の概要
詳細な説明
Transrectal ultrasound (TRUS)-guided prostate biopsy (PB) is currently the standard for diagnosing prostate cancer and is one of the most commonly performed urologic procedures.
The complications that can occur after this procedure have been extensively described previously. Bleeding complications, namely hematuria, rectal bleeding, and hematospermia, are the most frequent, with a reported incidence of 20% to 70%, but they are almost exclusively self-limiting and of mild to moderate severity.
There is an increasing number of patients who require PB and antiplatelet medication simultaneously. This is because more middle-age and elderly patients are receiving long-term antithrombotic therapy mainly for prevention of cardiovascular events, and these patients form the majority of those at risk of prostate cancer. As with other surgical interventions, aspirin is typically discontinued 7 to 10 days before PB. However, discontinuing aspirin might increase the risk of cardiovascular events, while continuing aspirin before PB might not necessarily increase severe bleeding complications. Several studies have found no increase in bleeding complications in patients continuing low-dose aspirin. However, most of the studies were retrospective, and only one was randomized. Moreover, there has been no prospective randomized trial in East Asian patients, who have a lower risk of thrombosis and increased risk of bleeding during antithrombotic treatment for acute coronary syndrome than do white patients.
The aim of the present randomized study was to determine whether TRUS-guided PB performed in patients continuing low-dose aspirin (LDA) is associated with a greater incidence, duration, and severity of bleeding complications.
研究の種類
入学 (予想される)
段階
- フェーズ 4
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
The inclusion criteria are use of LDA (100 mg once daily) for primary prevention of cardiovascular disease and not at a high risk of cardiovascular event. The definition of high risk includes #1-7 of the following exclusion criteria or unsuitable conditions by clinical judgement.
Exclusion Criteria:
- Angina in the past 3 months
- Exertional dyspnea on walking or climbing stairs for one floor
- Stroke in the past 6 months
- Coronary catheterization in the past 6 months
- Left main disease or 3-vessel disease
- Prior coronary arterial bypass graft surgery
- Use of dual (or more) antiplatelet agents
- Coagulopathy or diseases with bleeding tendency
- Hemorrhoid, anal or rectal diseases
- History of urinary stone or tumor
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：A
continuing LDA
|
aspirin is continued by its regular dosing
|
|
介入なし：B
discontinuing LDA
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Compications
時間枠：3 weeks
|
To determine whether the incidence, duration, and severity of bleeding complications after transrectal prostate biopsy (PB) in patients not discontinuing low-dose aspirin (LDA) are greater than in those discontinuing it.
|
3 weeks
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Maan Z, Cutting CW, Patel U, Kerry S, Pietrzak P, Perry MJ, Kirby RS. Morbidity of transrectal ultrasonography-guided prostate biopsies in patients after the continued use of low-dose aspirin. BJU Int. 2003 Jun;91(9):798-800. doi: 10.1046/j.1464-410x.2003.04238.x.
- Berger AP, Gozzi C, Steiner H, Frauscher F, Varkarakis J, Rogatsch H, Bartsch G, Horninger W. Complication rate of transrectal ultrasound guided prostate biopsy: a comparison among 3 protocols with 6, 10 and 15 cores. J Urol. 2004 Apr;171(4):1478-80; discussion 1480-1. doi: 10.1097/01.ju.0000116449.01186.f7.
- Ihezue CU, Smart J, Dewbury KC, Mehta R, Burgess L. Biopsy of the prostate guided by transrectal ultrasound: relation between warfarin use and incidence of bleeding complications. Clin Radiol. 2005 Apr;60(4):459-63; discussion 457-8. doi: 10.1016/j.crad.2004.10.014.
- Chiang IN, Chang SJ, Pu YS, Huang KH, Yu HJ, Huang CY. Major complications and associated risk factors of transrectal ultrasound guided prostate needle biopsy: a retrospective study of 1875 cases in taiwan. J Formos Med Assoc. 2007 Nov;106(11):929-34. doi: 10.1016/S0929-6646(08)60063-7.
- Ehrlich Y, Yossepowitch O, Margel D, Lask D, Livne PM, Baniel J. Early initiation of aspirin after prostate and transurethral bladder surgeries is not associated with increased incidence of postoperative bleeding: a prospective, randomized trial. J Urol. 2007 Aug;178(2):524-8; discussion 528. doi: 10.1016/j.juro.2007.03.134. Epub 2007 Jun 14.
- Giannarini G, Mogorovich A, Valent F, Morelli G, De Maria M, Manassero F, Barbone F, Selli C. Continuing or discontinuing low-dose aspirin before transrectal prostate biopsy: results of a prospective randomized trial. Urology. 2007 Sep;70(3):501-5. doi: 10.1016/j.urology.2007.04.016. Epub 2007 Aug 3.
- Ecke TH, Gunia S, Bartel P, Hallmann S, Koch S, Ruttloff J. Complications and risk factors of transrectal ultrasound guided needle biopsies of the prostate evaluated by questionnaire. Urol Oncol. 2008 Sep-Oct;26(5):474-8. doi: 10.1016/j.urolonc.2007.12.003. Epub 2008 Mar 4.
- Halliwell OT, Yadegafar G, Lane C, Dewbury KC. Transrectal ultrasound-guided biopsy of the prostate: aspirin increases the incidence of minor bleeding complications. Clin Radiol. 2008 May;63(5):557-61. doi: 10.1016/j.crad.2007.09.014. Epub 2008 Jan 11.
- Carmignani L, Picozzi S, Bozzini G, Negri E, Ricci C, Gaeta M, Pavesi M. Transrectal ultrasound-guided prostate biopsies in patients taking aspirin for cardiovascular disease: A meta-analysis. Transfus Apher Sci. 2011 Dec;45(3):275-80. doi: 10.1016/j.transci.2011.10.008. Epub 2011 Oct 24.
- Chowdhury R, Abbas A, Idriz S, Hoy A, Rutherford EE, Smart JM. Should warfarin or aspirin be stopped prior to prostate biopsy? An analysis of bleeding complications related to increasing sample number regimes. Clin Radiol. 2012 Dec;67(12):e64-70. doi: 10.1016/j.crad.2012.08.005. Epub 2012 Sep 7.
- Raheem OA, Casey RG, Galvin DJ, Manecksha RP, Varadaraj H, McDermott T, Grainger R, Lynch TH. Discontinuation of anticoagulant or antiplatelet therapy for transrectal ultrasound-guided prostate biopsies: a single-center experience. Korean J Urol. 2012 Apr;53(4):234-9. doi: 10.4111/kju.2012.53.4.234. Epub 2012 Apr 18.
- Wang J, Zhang C, Tan G, Chen W, Yang B, Tan D. Risk of bleeding complications after preoperative antiplatelet withdrawal versus continuing antiplatelet drugs during transurethral resection of the prostate and prostate puncture biopsy: a systematic review and meta-analysis. Urol Int. 2012;89(4):433-8. doi: 10.1159/000343733. Epub 2012 Nov 13.
- Culkin DJ, Exaire EJ, Green D, Soloway MS, Gross AJ, Desai MR, White JR, Lightner DJ. Anticoagulation and antiplatelet therapy in urological practice: ICUD/AUA review paper. J Urol. 2014 Oct;192(4):1026-34. doi: 10.1016/j.juro.2014.04.103. Epub 2014 May 21.
研究記録日
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研究開始
一次修了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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最終確認日
詳しくは
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