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Management of Gastrointestinal and Urogenital (GI/GU) Bleedings in Atrial Fibrillation Patients Using Pradaxa

2016年12月8日 更新者：Boehringer Ingelheim

An Observational Study Assessing the Management of Gastrointestinal and Urogenital Bleeding Events in Patients With Atrial Fibrillation Treated With Dabigatran Etexilate

This study is being conducted to collect data on the management of gastrointestinal and urogenital bleeding events occurring in patients with atrial fibrillation taking dabigatran etexilate.

研究概览

地位

完全的

条件

详细说明

Purpose:

研究类型

观察性的

注册 (实际的)

220

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

  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大
        • Boehringer Ingelheim Investigational Site
    • British Columbia
      • Vancouver、British Columbia、加拿大
        • Boehringer Ingelheim Investigational Site
    • New Brunswick
      • Saint John、New Brunswick、加拿大
        • Boehringer Ingelheim Investigational Site
    • Nova Scotia
      • Halifax、Nova Scotia、加拿大
        • Boehringer Ingelheim Investigational Site
    • Ontario
      • Hamilton、Ontario、加拿大
        • Boehringer Ingelheim Investigational Site
    • Quebec
      • Montreal、Quebec、加拿大
        • Boehringer Ingelheim Investigational Site
  • 美国
    • Colorado
      • Aurora、Colorado、美国
        • Boehringer Ingelheim Investigational Site
    • Connecticut
      • New Britain、Connecticut、美国
        • Boehringer Ingelheim Investigational Site
    • Florida
      • Orlando、Florida、美国
        • Boehringer Ingelheim Investigational Site
      • Tampa、Florida、美国
        • Boehringer Ingelheim Investigational Site
    • Louisiana
      • New Orleans、Louisiana、美国
        • Boehringer Ingelheim Investigational Site
    • Massachusetts
      • Springfield、Massachusetts、美国
        • Boehringer Ingelheim Investigational Site
    • Missouri
      • Chesterfield、Missouri、美国
        • Boehringer Ingelheim Investigational Site
      • St. Louis、Missouri、美国
        • Boehringer Ingelheim Investigational Site
    • New Jersey
      • Hackensack、New Jersey、美国
        • Boehringer Ingelheim Investigational Site
    • New York
      • New York、New York、美国
        • Boehringer Ingelheim Investigational Site
      • Staten Island、New York、美国
        • Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Philedelphia、Pennsylvania、美国
        • Boehringer Ingelheim Investigational Site
    • Tennessee
      • Nashville、Tennessee、美国
        • Boehringer Ingelheim Investigational Site
    • Virginia
      • Charlottesville、Virginia、美国
        • Boehringer Ingelheim Investigational Site
      • Norfolk、Virginia、美国
        • Boehringer Ingelheim Investigational Site
      • Roanoke、Virginia、美国
        • 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

AF patients with bleeding event using Dabigatran etexilate

描述

Inclusion criteria:

  • >=18 years of age;
  • Confirmed diagnosis of Atrial Fibrillation (AF);
  • Documentation that the patient had an acute GI and/or GU bleeding event and having taken at least one dose of dabigatran prior to the event.

Exclusion criteria:

  • Confirmed diagnosis of valvular AF (VAF);
  • Documentation that the patient was taking dabigatran with other oral anticoagulant;
  • Documentation of the patient receiving thrombolytic therapy prior to the event;
  • Documentation that the patient was enrolled in an investigational clinical trial at the time of the event;
  • Medical record was not available.

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

  • 观测模型：队列
  • 时间观点：追溯

队列和干预

团体/队列
第 1 组

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 Index Event Safety Outcomes (Ongoing/Resolved/Deceased) at Time of Hospital Discharge
大体时间：From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28October2010 (the date of the first data entry)) and 01August2013 (the date of data entry closure); Up to 1008 days.

Percentages of patients with index event safety outcomes (ongoing/resolved/deceased) at the time of their hospital discharge/release.

Emergency Department/Room (ED/ER).

Bleeding status at the time of discharge were classified by the principal investigator, using medical record information and medical opinion, as:

  • Ongoing, if symptoms of bleeding not completely resolved at time of discharge;
  • Deceased in case of death;
  • Resolved otherwise.
From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28October2010 (the date of the first data entry)) and 01August2013 (the date of data entry closure); Up to 1008 days.
Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge
大体时间：From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28OCT2010 (the date of the first data entry)) and 01AUG2013 (the date of data entry closure); Up to 1008 days.
Percentages of patients receiving general intervention and general intervention combinations (i.e., medications, surgery, therapeutic procedures, transfusion/infusion, discontinuation of dabigatran) to manage the index events until their hospital discharge/release. Multiple interventions are possible.
From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28OCT2010 (the date of the first data entry)) and 01AUG2013 (the date of data entry closure); Up to 1008 days.
Percentage of Bleeding Types and Anatomic Locations of the Index Event at Time of ED/ER Presentation
大体时间：From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28OCT2010 (the date of the first data entry)) and 01AUG2013 (the date of data entry closure); Up to 1008 days.
Percentages of patients with index events by type (i.e. GI and/or GU) and anatomic location are presented. Multiple bleed locations are possible.
From the time of presentation/admission to an ED/ER or hospitalization through all in-hospital referrals until discharge (between 28OCT2010 (the date of the first data entry)) and 01AUG2013 (the date of data entry closure); Up to 1008 days.

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。

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

2014年1月1日

初级完成 (实际的)

2015年10月1日

研究完成 (实际的)

2015年10月1日

研究注册日期

首次提交

2013年11月25日

首先提交符合 QC 标准的

2013年12月20日

首次发布 (估计)

2013年12月27日

研究记录更新

最后更新发布 (估计)

2017年1月31日

上次提交的符合 QC 标准的更新

2016年12月8日

最后验证

2016年12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

  • 1160.162

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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