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

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT02022020
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Purpose:

Study Timeline

• Study First Submitted: 2013-11-25
• Study First Submitted QC: 2013-12-20
• Study First Posted: 2013-12-27
• Study Start: 2014-01
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Results First Submitted: 2016-10-05
• Status Verified: 2016-12
• Results First Submitted QC: 2016-12-08
• Last Update Submitted: 2016-12-08
• Results First Posted: 2017-01-31
• Last Update Posted: 2017-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With Index Event Safety Outcomes (Ongoing/Resolved/Deceased) at Time of Hospital Discharge	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.
Percentage of Bleeding Types and Anatomic Locations of the Index Event at Time of ED/ER Presentation	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.
Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge	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.

Trial Locations

Locations (1)

Boehringer Ingelheim Investigational Site; 🇨🇦 Montreal, Quebec, Canada