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

Study Overview
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Brief Summary
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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
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Purpose:

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

Conditions
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Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients With Index Event Safety Outcomes (Ongoing/Resolved/Deceased) at Time of Hospital Discharge | 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 | 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 | 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. |