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

N/ACompletedNCT02022020

Boehringer Ingelheim220 enrolled

Overview

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.

Purpose:

Study Type

OBSERVATIONAL

Enrollment

220

Conditions

Atrial Fibrillation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (22)

Boehringer Ingelheim Investigational Site

Aurora, Colorado, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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