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Pradaxa (Dabigatran Etexilate 220 mg/q.d. in the General Population After Hip or Knee Replacement Surgery

2012年9月13日 更新者：Boehringer Ingelheim

Observational Cohort Study to Evaluate the Safety and Efficacy of Pradaxa (Dabigatran Etexilate) for the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement Surgery or Total Knee Replacement Surgery in a Routine Clinical Setting.

An observational cohort study on safety and efficacy of the 220 mg dose Pradaxa to generate additional data in predefined sub populations of patients at increased risk of bleeding or VTE

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

5476

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
      • Graz、奥地利
        • 1160.85.4308 Boehringer Ingelheim Investigational Site
      • Klagenfurt、奥地利
        • 1160.85.4309 Boehringer Ingelheim Investigational Site
      • Linz、奥地利
        • 1160.85.4303 Boehringer Ingelheim Investigational Site
      • Linz、奥地利
        • 1160.85.4304 Boehringer Ingelheim Investigational Site
      • St. Johann/Tirol、奥地利
        • 1160.85.4305 Boehringer Ingelheim Investigational Site
      • Stolzalpe、奥地利
        • 1160.85.4312 Boehringer Ingelheim Investigational Site
      • Wels、奥地利
        • 1160.85.4307 Boehringer Ingelheim Investigational Site
      • Wien、奥地利
        • 1160.85.4301 Boehringer Ingelheim Investigational Site
      • Wien、奥地利
        • 1160.85.4302 Boehringer Ingelheim Investigational Site
      • Wien、奥地利
        • 1160.85.4310 Boehringer Ingelheim Investigational Site
      • Wien、奥地利
        • 1160.85.4311 Boehringer Ingelheim Investigational Site
  • 德国
      • Bad Homburg、德国
        • 1160.85.04924 Boehringer Ingelheim Investigational Site
      • Bayreuth、德国
        • 1160.85.04926 Boehringer Ingelheim Investigational Site
      • Berlin、德国
        • 1160.85.04903 Boehringer Ingelheim Investigational Site
      • Bochum、德国
        • 1160.85.04931 Boehringer Ingelheim Investigational Site
      • Breitenbrunn、德国
        • 1160.85.04930 Boehringer Ingelheim Investigational Site
      • Chemnitz、德国
        • 1160.85.04923 Boehringer Ingelheim Investigational Site
      • Erlangen、德国
        • 1160.85.04947 Boehringer Ingelheim Investigational Site
      • Fürth、德国
        • 1160.85.04945 Boehringer Ingelheim Investigational Site
      • Garmische-Partenkirchen、德国
        • 1160.85.04912 Boehringer Ingelheim Investigational Site
      • Gelnhausen、德国
        • 1160.85.04922 Boehringer Ingelheim Investigational Site
      • Gelsenkirchen、德国
        • 1160.85.04917 Boehringer Ingelheim Investigational Site
      • Günzburg、德国
        • 1160.85.04949 Boehringer Ingelheim Investigational Site
      • Hachenburg、德国
        • 1160.85.04927 Boehringer Ingelheim Investigational Site
      • Hamburg、德国
        • 1160.85.04910 Boehringer Ingelheim Investigational Site
      • Hannover、德国
        • 1160.85.04906 Boehringer Ingelheim Investigational Site
      • Hof、德国
        • 1160.85.04920 Boehringer Ingelheim Investigational Site
      • Kamp-Linfort、德国
        • 1160.85.04916 Boehringer Ingelheim Investigational Site
      • Kassel、德国
        • 1160.85.04939 Boehringer Ingelheim Investigational Site
      • Koblenz、德国
        • 1160.85.04929 Boehringer Ingelheim Investigational Site
      • Landstuhl、德国
        • 1160.85.04909 Boehringer Ingelheim Investigational Site
      • Lübben、德国
        • 1160.85.04944 Boehringer Ingelheim Investigational Site
      • Mainz、德国
        • 1160.85.04935 Boehringer Ingelheim Investigational Site
      • Marburg、德国
        • 1160.85.04902 Boehringer Ingelheim Investigational Site
      • Markgröningen、德国
        • 1160.85.04934 Boehringer Ingelheim Investigational Site
      • Marktheidenfeld、德国
        • 1160.85.04918 Boehringer Ingelheim Investigational Site
      • Merseburg、德国
        • 1160.85.04941 Boehringer Ingelheim Investigational Site
      • Minden、德国
        • 1160.85.04952 Boehringer Ingelheim Investigational Site
      • München、德国
        • 1160.85.04943 Boehringer Ingelheim Investigational Site
      • München、德国
        • 1160.85.04946 Boehringer Ingelheim Investigational Site
      • Nürnberg、德国
        • 1160.85.04904 Boehringer Ingelheim Investigational Site
      • Olsberg、德国
        • 1160.85.04913 Boehringer Ingelheim Investigational Site
      • Pfortzheim、德国
        • 1160.85.04932 Boehringer Ingelheim Investigational Site
      • Rosenheim、德国
        • 1160.85.04901 Boehringer Ingelheim Investigational Site
      • Rostock、德国
        • 1160.85.04915 Boehringer Ingelheim Investigational Site
      • Rostock、德国
        • 1160.85.04928 Boehringer Ingelheim Investigational Site
      • Rotenburg/Fulda、德国
        • 1160.85.04936 Boehringer Ingelheim Investigational Site
      • Schwarzenbruck、德国
        • 1160.85.04905 Boehringer Ingelheim Investigational Site
      • Sylt、德国
        • 1160.85.04914 Boehringer Ingelheim Investigational Site
      • Wertheim、德国
        • 1160.85.04933 Boehringer Ingelheim Investigational Site
      • Wiesbaden、德国
        • 1160.85.04921 Boehringer Ingelheim Investigational Site
      • Wismar、德国
        • 1160.85.04938 Boehringer Ingelheim Investigational Site
      • Worms、德国
        • 1160.85.04907 Boehringer Ingelheim Investigational Site
      • Würzburg、德国
        • 1160.85.04940 Boehringer Ingelheim Investigational Site
      • Würzburg、德国
        • 1160.85.04948 Boehringer Ingelheim Investigational Site
  • 意大利
      • Bari、意大利
        • 1160.85.03911 Boehringer Ingelheim Investigational Site
      • Firenze、意大利
        • 1160.85.03905 Boehringer Ingelheim Investigational Site
      • Genova、意大利
        • 1160.85.03904 Boehringer Ingelheim Investigational Site
      • Jesi (an)、意大利
        • 1160.85.03906 Boehringer Ingelheim Investigational Site
      • Latina、意大利
        • 1160.85.03914 Boehringer Ingelheim Investigational Site
      • Mantova、意大利
        • 1160.85.03901 Boehringer Ingelheim Investigational Site
      • Ome (bs)、意大利
        • 1160.85.03913 Boehringer Ingelheim Investigational Site
      • Roma、意大利
        • 1160.85.03907 Boehringer Ingelheim Investigational Site
      • Torino、意大利
        • 1160.85.03909 Boehringer Ingelheim Investigational Site
      • Vimercate (mi)、意大利
        • 1160.85.03910 Boehringer Ingelheim Investigational Site
  • 法国
      • Angers、法国
        • 1160.85.3306A Boehringer Ingelheim Investigational Site
      • Bois Guillaume Cédex、法国
        • 1160.85.3318A Boehringer Ingelheim Investigational Site
      • Bordeaux、法国
        • 1160.85.3333A Boehringer Ingelheim Investigational Site
      • Caen Cedex 9、法国
        • 1160.85.3310A Boehringer Ingelheim Investigational Site
      • Clermont-Ferrand cedex 1、法国
        • 1160.85.3311A Boehringer Ingelheim Investigational Site
      • Creteil、法国
        • 1160.85.3315A Boehringer Ingelheim Investigational Site
      • DIJON Cédex、法国
        • 1160.85.3305A Boehringer Ingelheim Investigational Site
      • Illkirch、法国
        • 1160.85.3304A Boehringer Ingelheim Investigational Site
      • Le Havre、法国
        • 1160.85.3334A Boehringer Ingelheim Investigational Site
      • Les Lilas、法国
        • 1160.85.3324A Boehringer Ingelheim Investigational Site
      • Lille cedex、法国
        • 1160.85.3309A Boehringer Ingelheim Investigational Site
      • Lyon、法国
        • 1160.85.3307A Boehringer Ingelheim Investigational Site
      • Marseille、法国
        • 1160.85.3325A Boehringer Ingelheim Investigational Site
      • Metz、法国
        • 1160.85.3323A Boehringer Ingelheim Investigational Site
      • Nantes Cédex 2、法国
        • 1160.85.3321A Boehringer Ingelheim Investigational Site
      • Paris、法国
        • 1160.85.3303A Boehringer Ingelheim Investigational Site
      • Paris、法国
        • 1160.85.3320A Boehringer Ingelheim Investigational Site
      • Paris cedex 10、法国
        • 1160.85.3301A Boehringer Ingelheim Investigational Site
      • Paris cedex 14、法国
        • 1160.85.3302A Boehringer Ingelheim Investigational Site
      • Pierre Bénite cedex、法国
        • 1160.85.3308A Boehringer Ingelheim Investigational Site
      • Poitiers Cédex、法国
        • 1160.85.3322A Boehringer Ingelheim Investigational Site
      • Saint Etienne Cédex 2、法国
        • 1160.85.3319A Boehringer Ingelheim Investigational Site
      • Saint Saulve、法国
        • 1160.85.3317A Boehringer Ingelheim Investigational Site
      • Toulouse Cedex 9、法国
        • 1160.85.3314A Boehringer Ingelheim Investigational Site
      • Toulouse Cédex 9、法国
        • 1160.85.3313A Boehringer Ingelheim Investigational Site
      • Vannes Cédex、法国
        • 1160.85.3331A Boehringer Ingelheim Investigational Site
  • 波兰
      • Koscierzyna、波兰
        • 1160.85.4805 Boehringer Ingelheim Investigational Site
      • Lodz、波兰
        • 1160.85.4804 Boehringer Ingelheim Investigational Site
      • Otwock、波兰
        • 1160.85.4803 Boehringer Ingelheim Investigational Site
      • Piekary Slaskie、波兰
        • 1160.85.4802 Boehringer Ingelheim Investigational Site
      • Swiebodzin、波兰
        • 1160.85.4806 Boehringer Ingelheim Investigational Site
  • 爱尔兰
      • Croom、爱尔兰
        • 1160.85.35301 Boehringer Ingelheim Investigational Site
  • 瑞典
      • Kungälv、瑞典
        • 1160.85.4603 Boehringer Ingelheim Investigational Site
      • Motala、瑞典
        • 1160.85.4601 Boehringer Ingelheim Investigational Site
      • Solleftea、瑞典
        • 1160.85.4604 Boehringer Ingelheim Investigational Site
  • 英国
      • Basildon、英国
        • 1160.85.04405 Boehringer Ingelheim Investigational Site
      • Gateshead、英国
        • 1160.85.04406 Boehringer Ingelheim Investigational Site
      • Halifax、英国
        • 1160.85.04402 Boehringer Ingelheim Investigational Site
      • London、英国
        • 1160.85.04404 Boehringer Ingelheim Investigational Site
      • Luton、英国
        • 1160.85.04403 Boehringer Ingelheim Investigational Site
      • Wigan、英国
        • 1160.85.04401 Boehringer Ingelheim Investigational Site
  • 西班牙
      • Madrid、西班牙
        • 1160.85.3404 Boehringer Ingelheim Investigational Site
      • Madrid、西班牙
        • 1160.85.3406 Boehringer Ingelheim Investigational Site
      • Malaga、西班牙
        • 1160.85.3405 Boehringer Ingelheim Investigational Site
      • Pamplona、西班牙
        • 1160.85.3407 Boehringer Ingelheim Investigational Site
      • Valencia、西班牙
        • 1160.85.3401 Boehringer Ingelheim Investigational Site
      • Zaragoza、西班牙
        • 1160.85.3402 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 至 75年 (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

Subgroups of the general population

描述

Inclusion criteria:

Patients of 18 years of age or above undergoing elective total hip or knee replacement surgery who consent in writing to their participation in this observational study

Exclusion criteria:

All patients who should not be treated with Pradaxa 220 mg according to the European Summary of Product Characteristics (SPC): age of > 75 years, renal impairment (creatinine clearance <50 ml/min), patients with concomitant therapy of amiodarone, elevated liver enzymes > 2 upper limit of normal (ULN) and/or 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 except for the above included patients groups, concomitant treatment with quinidine

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
Patients 75 years or younger

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) During Treatment Period
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).
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
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
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 end of surgery (before first dosing) until 24 hours after last intake (planned: knee replacement: Day 10 after surgery, hip replacement: Day 28-35 after surgery) of Pradaxa
Total volume of wound drainage is calculated as sum of volume drainage from end of surgery until first dose of Pradaxa plus volume drainage from first dose of Pradaxa and onwards.
From end of surgery (before first dosing) 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 Single Components of Composite of 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
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

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

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2月1日

初级完成 (实际的)

2011年7月1日

研究注册日期

首次提交

2009年2月13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)

2012年9月18日

上次提交的符合 QC 标准的更新

2012年9月13日

最后验证

2012年9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

  • 1160.85

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.

搜索类似试验

赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Malta

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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