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Pradaxa (Dabigatran Etexilate) 150 mg/q.d. in Patients With Moderate Renal Impairment After Hip or Knee Replacement Surgery

2015年8月25日 更新者：Boehringer Ingelheim

Observational Cohort Study to Evaluate Safety and Efficacy of Pradaxa (Dabigatran Etexilate) in Patients With Moderate Renal Impairment (Creatinine Clearance 30-50 ml/Min) Undergoing Elective Total Hip Replacement Surgery or Total Knee Replacement Surgery

An observational cohort study on safety and efficacy to generate additional data on the benefit/risk profile of the 150 mg dose of Pradaxa in patients with renal impairment

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

472

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 奥地利
      • Wien、奥地利
        • 1160.84.4301 Boehringer Ingelheim Investigational Site
      • Wien、奥地利
        • 1160.84.4310 Boehringer Ingelheim Investigational Site
  • 德国
      • Berlin、德国
        • 1160.84.04903 Boehringer Ingelheim Investigational Site
      • Erlangen、德国
        • 1160.84.04947 Boehringer Ingelheim Investigational Site
      • Gelnhausen、德国
        • 1160.84.4922 Boehringer Ingelheim Investigational Site
      • Hachenburg、德国
        • 1160.84.04927 Boehringer Ingelheim Investigational Site
      • Koblenz、德国
        • 1160.84.04929 Boehringer Ingelheim Investigational Site
      • Marburg、德国
        • 1160.84.04902 Boehringer Ingelheim Investigational Site
      • München、德国
        • 1160.84.04946 Boehringer Ingelheim Investigational Site
      • Olsberg、德国
        • 1160.84.04913 Boehringer Ingelheim Investigational Site
      • Sylt、德国
        • 1160.84.04914 Boehringer Ingelheim Investigational Site
      • Wismar、德国
        • 1160.84.04938 Boehringer Ingelheim Investigational Site
      • Würzburg、德国
        • 1160.84.04948 Boehringer Ingelheim Investigational Site
  • 意大利
      • Latina、意大利
        • 1160.84.03908 Boehringer Ingelheim Investigational Site
      • Milano、意大利
        • 1160.84.03902 Boehringer Ingelheim Investigational Site
      • Monza、意大利
        • 1160.84.03904 Boehringer Ingelheim Investigational Site
      • Udine、意大利
        • 1160.84.03909 Boehringer Ingelheim Investigational Site
  • 法国
      • Angers、法国
        • 1160.84.3311 Boehringer Ingelheim Investigational Site
      • Bordeaux、法国
        • 1160.84.3334 Boehringer Ingelheim Investigational Site
      • Caen Cedex 5、法国
        • 1160.84.3303 Boehringer Ingelheim Investigational Site
      • Clermont-Ferrand cedex 1、法国
        • 1160.84.3314 Boehringer Ingelheim Investigational Site
      • Creteil、法国
        • 1160.84.3320 Boehringer Ingelheim Investigational Site
      • DIJON Cédex、法国
        • 1160.84.3307 Boehringer Ingelheim Investigational Site
      • Illkirch、法国
        • 1160.84.3310 Boehringer Ingelheim Investigational Site
      • Le Havre、法国
        • 1160.84.3335 Boehringer Ingelheim Investigational Site
      • Les Lilas、法国
        • 1160.84.3326 Boehringer Ingelheim Investigational Site
      • Lyon、法国
        • 1160.84.3312 Boehringer Ingelheim Investigational Site
      • Marseille、法国
        • 1160.84.3305 Boehringer Ingelheim Investigational Site
      • Nantes Cédex 2、法国
        • 1160.84.3323 Boehringer Ingelheim Investigational Site
      • Paris、法国
        • 1160.84.3302 Boehringer Ingelheim Investigational Site
      • Paris、法国
        • 1160.84.3306 Boehringer Ingelheim Investigational Site
      • Pierre Bénite cedex、法国
        • 1160.84.3313 Boehringer Ingelheim Investigational Site
      • Poitiers Cédex、法国
        • 1160.84.3324 Boehringer Ingelheim Investigational Site
      • Saint Etienne Cédex 2、法国
        • 1160.84.3322 Boehringer Ingelheim Investigational Site
      • Saint Saulve、法国
        • 1160.84.3319 Boehringer Ingelheim Investigational Site
      • Toulouse Cédex 9、法国
        • 1160.84.3316 Boehringer Ingelheim Investigational Site
      • Vannes Cédex、法国
        • 1160.84.3332 Boehringer Ingelheim Investigational Site
  • 瑞典
      • Kungälv、瑞典
        • 1160.84.4603 Boehringer Ingelheim Investigational Site
      • Motala、瑞典
        • 1160.84.4601 Boehringer Ingelheim Investigational Site
      • Sollefteå、瑞典
        • 1160.84.4604 Boehringer Ingelheim Investigational Site
  • 英国
      • Basildon、英国
        • 1160.84.04405 Boehringer Ingelheim Investigational Site
      • Bedford、英国
        • 1160.84.04408 Boehringer Ingelheim Investigational Site
      • Luton、英国
        • 1160.84.04403 Boehringer Ingelheim Investigational Site
      • Wigan、英国
        • 1160.84.04401 Boehringer Ingelheim Investigational Site
      • Yeovil、英国
        • 1160.84.04407 Boehringer Ingelheim Investigational Site
  • 西班牙
      • Badalona (Barcelona)、西班牙
        • 1160.84.3409 Boehringer Ingelheim Investigational Site
      • Barcelona、西班牙
        • 1160.84.3410 Boehringer Ingelheim Investigational Site
      • Madrid、西班牙
        • 1160.84.3403 Boehringer Ingelheim Investigational Site
      • Malaga、西班牙
        • 1160.84.3405 Boehringer Ingelheim Investigational Site
      • Pamplona、西班牙
        • 1160.84.3404 Boehringer Ingelheim Investigational Site
      • Pozuelo de Alarcón - Madrid、西班牙
        • 1160.84.3412 Boehringer Ingelheim Investigational Site
      • Valencia、西班牙
        • 1160.84.3401 Boehringer Ingelheim Investigational Site
      • Zaragoza、西班牙
        • 1160.84.3402 Boehringer Ingelheim Investigational Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Moderate renal insufficiency

描述

Inclusion criteria:

Patients of 18 years of age or above with moderate renal impairment (creatinine clearance 30-50 ml/min) undergoing elective total hip replacement surgery who consent in writing to their participation in this observational study

Exclusion criteria:

All patients who should not be treated with Pradaxa 150 mg according to the European Summary of Product Characteristics (SPC):

severe renal impairment (creatinine clearance < 30 ml/min); elevated liver enzymes > 2 upper limit of normal (ULN); Hepatic impairment or liver disease expected to have any impact on survival, anaesthesia with post-operative indwelling epidural catheters, hypersensitivity to dabigatran etexilate or to any of the excipients, active clinically significant bleeding, organic lesion at risk of bleeding, spontaneous or pharmacological impairment of haemostasis, concomitant treatment with quinidine, protehetic heart valve requiring anticoagulant treatment

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
Renal Impairment

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percentage of Patients With Major Bleeding Events (MBE)
大体时间：From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
Major bleeding events were defined according to the modified McMaster criteria, and were classified by the investigator as Major bleeding event or Any bleeding event. The criteria for MBE's were: fatal; clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected; clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected; symptomatic retroperitoneal, intracranial, intraocular or intraspinal; requiring treatment cessation; leading to re-operation
From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
Percentage of Patients With Symptomatic Venous Thromboembolic Events (sVTE) and All Cause Mortality
大体时间：From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
The co-primary efficacy variable sVTE was defined as the composite of documented symptomatic proximal and distal deep vein thrombosis (DVT) and documented symptomatic non-fatal pulmonary embolism (PE) and All Cause Mortality.
From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa

次要结果测量

结果测量
措施说明
大体时间
Documented Symptomatic Proximal DVT, Documented Symptomatic Distal DVT, Documented Symptomatic Nonfatal Pulmonary Embolism and All-cause Mortality
大体时间：From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
Percentage of participant with documented symptomatic proximal DVT (deep vein thrombosis), documented symptomatic distal DVT, documented symptomatic nonfatal pulmonary embolism and all-cause mortality
From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
Percentage of Patients With Major Extra-surgical Site Bleedings
大体时间：From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
Percentage of Patients With Major Extra-surgical Site Bleedings
From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
Volume of Wound Drainage (Post-operative)
大体时间：From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
Volume of Wound Drainage after surgery
From first intake (day of surgery) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Boehringer Ingelheim

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年4月1日

初级完成 (实际的)

2014年7月1日

研究完成 (实际的)

2014年7月1日

研究注册日期

首次提交

2009年2月18日

首先提交符合 QC 标准的

2009年2月18日

首次发布 (估计)

2009年2月19日

研究记录更新

最后更新发布 (估计)

2015年9月25日

上次提交的符合 QC 标准的更新

2015年8月25日

最后验证

2015年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 1160.84

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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