Clinical trial NCT02149303: Management of Major Bleeding Events in Atrial Fibrillation Patients Using Pradaxa
Official title: A Retrospective Cohort Study With Chart Review to Assess the Management of Major Bleeding Events in NVAF Patients Treated With Dabigatran Etexilate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Hemorrhage
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-05-29
Enrollment: 191
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 major bleeding events occurring in patients with atrial fibrillation taking dabigatran etexilate.

Detailed description: Purpose:

Eligibility criteria: Inclusion criteria:

* Greater than or equal to 18 years of age;
* Confirmed diagnosis of non valvular atrial fibrillation (NVAF) (Diagnosis of AF is considered confirmed if there is medical chart documentation that the patient has atrial fibrillation or AF or the ICD-9 or ICD-10 code for AF is documented);
* NVAF is defined as follows: nonvalvular atrial fibrillation is restricted to cases in which the rhythm disturbance occurs in the absence of rheumatic mitral stenosis or a prosthetic heart valve.
* Documentation that the patient presented to an emergency department/emergency room (ED/ER) for a major bleeding event (index event);
* Major bleeding is defined by International Society on Thrombosis and Haemostasis (ISTH) as:
* fatal bleeding and/or
* symptomatic bleeding in a critical area/organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or
* bleeding causing a fall in hemoglobin of 20g per liter or more, or leading to transfusion of 2 or more units of whole blood or red blood cells
* Documentation that the index event occurred in a patient who reported having taken at least one dose of dabigatran within the 5 days prior to the index event.

Exclusion criteria:

* Confirmed diagnosis of valvular AF (Diagnosis of valvular AF is considered confirmed if there is medical chart documentation that the patient has valvular AF or VAF. In the absence of documentation to indicate whether the patient has non-valvular or valvular AF,);
* Documentation that the patient was taking dabigatran with a concomitant anticoagulant (contemporaneous parenteral anticoagulant or another oral anticoagulant) within 72 hours of the index event;
* The concomitant administration of antiplatelet medications prior to the onset of the index event is not exclusionary;
* Documentation of the patient receiving thrombolytic therapy within 48 hours of the onset of the index event;
* Documentation that the patient was enrolled in an interventional investigational or other BI observational clinical trial at the time of the onset of the index event;
* Medical record was not retrievable, was missing or empty.

Primary outcomes:
measure: Proportion of Subjects With Index Event Safety Outcomes (Resolved / Recovery Ongoing / Deceased) at the Time of Their Hospital Discharge / Release.
timeFrame: From the time of presentation / admission to an ED / ER or hospitalization through all in-hospital referrals until discharge (between 20 August 2014 (the date of the first data entry) and 4 March 2015 (the date of data entry closure)); Up to 196 days
measure: Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release
timeFrame: From the time of presentation / admission to an ED / ER or hospitalization through all in-hospital referrals until discharge (between 20 August 2014 (the date of the first data entry) and 4 March 2015 (the date of data entry closure)); Up to 196 days
measure: Index Event Characteristics (i.e. Type of Bleeding and Anatomic Locations of the Index Event) at the Time of the ED / ER Presentation or Hospitalization
timeFrame: From the time of presentation / admission to an ED / ER or hospitalization through all in-hospital referrals until discharge (between 20 August 2014 (the date of the first data entry) and 4 March 2015 (the date of data entry closure)); Up to 196 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: 1160.200.02 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: 1160.200.06 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Brooklyn
country: United States
facility: 1160.200.01 Boehringer Ingelheim Investigational Site
state: New York
city: Stony Brook
country: United States
facility: 1160.200.05 Boehringer Ingelheim Investigational Site
state: New York
city: Austin
country: United States
facility: 1160.200.03 Boehringer Ingelheim Investigational Site
state: Texas
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: