Management of Major Bleeding Events in Atrial Fibrillation Patients Using Pradaxa

A Retrospective Cohort Study With Chart Review to Assess the Management of Major Bleeding Events in NVAF Patients Treated With Dabigatran Etexilate

This study is being conducted to collect data on the management of major bleeding events occurring in patients with atrial fibrillation taking dabigatran etexilate.

Study Overview

• Status: Completed
• Conditions: Hemorrhage; Atrial Fibrillation
• Intervention / Treatment: Drug: Dabigatran 75 mg; Drug: Dabigatran 150 mg

Detailed Description

Purpose:

• Study Type: Observational
• Enrollment (Actual): 191

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States
      • 1160.200.02 Boehringer Ingelheim Investigational Site
    • Boston, Massachusetts, United States
      • 1160.200.06 Boehringer Ingelheim Investigational Site
  • New York
    • Brooklyn, New York, United States
      • 1160.200.01 Boehringer Ingelheim Investigational Site
    • Stony Brook, New York, United States
      • 1160.200.05 Boehringer Ingelheim Investigational Site
  • Texas
    • Austin, Texas, United States
      • 1160.200.03 Boehringer Ingelheim Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

AF patients with bleeding event using Dabigatran etexilate

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Dabigatran	Drug: Dabigatran 75 mg; PO BID; Drug: Dabigatran 150 mg; PO BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Subjects With Index Event Safety Outcomes (Resolved / Recovery Ongoing / Deceased) at the Time of Their Hospital Discharge / Release.	Proportion of subjects with index event safety outcomes (resolved / recovery ongoing / deceased) at the time of their hospital discharge / release.	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
Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release	Proportion of subjects receiving different types of interventions (i.e., medication / procedure and surgery) to manage the index events until their hospital discharge / release.	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
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	Proportion of Index events by anatomic location and type are presented. The categories of Unknown and Other presented below correspond to, Unknown: Unknown location of bleeding met the criteria for major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH). Other: Other types of bleeding represent a combined category of all other locations of bleeding whose incidence was <1.7%.	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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: May 19, 2014
• First Submitted That Met QC Criteria: May 26, 2014
• First Posted (Estimate): May 29, 2014

Study Record Updates

• Last Update Posted (Estimate): April 4, 2016
• Last Update Submitted That Met QC Criteria: March 3, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Dabigatran
• Other Study ID Numbers: 1160.200