Clinical trial NCT02022020: Management of Gastrointestinal and Urogenital (GI/GU) Bleedings in Atrial Fibrillation Patients Using Pradaxa
Official title: An Observational Study Assessing the Management of Gastrointestinal and Urogenital Bleeding Events in Patients With Atrial Fibrillation Treated With Dabigatran Etexilate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2013-12-27
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: AF patients with bleeding event using Dabigatran etexilate

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:

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Patients With Index Event Safety Outcomes (Ongoing/Resolved/Deceased) at Time of Hospital Discharge
timeFrame: 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.
measure: Percentage of Patients Receiving Different Types of Interventions to Stop Index Events Until Hospital Discharge
timeFrame: 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.
measure: Percentage of Bleeding Types and Anatomic Locations of the Index Event at Time of ED/ER Presentation
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Colorado
city: New Britain
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Connecticut
city: Orlando
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Florida
city: New Orleans
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Louisiana
city: Springfield
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Chesterfield
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Missouri
city: Hackensack
country: United States
facility: Boehringer Ingelheim Investigational Site
state: New Jersey
city: New York
country: United States
facility: Boehringer Ingelheim Investigational Site
state: New York
city: Staten Island
country: United States
facility: Boehringer Ingelheim Investigational Site
state: New York
city: Philedelphia
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Nashville
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Tennessee
city: Charlottesville
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Virginia
city: Norfolk
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Virginia
city: Roanoke
country: United States
facility: Boehringer Ingelheim Investigational Site
state: Virginia
city: Calgary
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: British Columbia
city: Saint John
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: New Brunswick
city: Halifax
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Quebec
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: