Management of Major Bleeding Events in Atrial Fibrillation Patients Using Pradaxa

Completed

• Conditions: Hemorrhage; Atrial Fibrillation
• Interventions: Drug: Dabigatran 75 mg; Drug: Dabigatran 150 mg

• Registration Number: NCT02149303
• Lead Sponsor: Boehringer Ingelheim

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:

Study Timeline

• Study First Submitted: 2014-05-19
• Study First Submitted QC: 2014-05-26
• Study First Posted: 2014-05-29
• Study Start: 2014-06
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2016-03
• Results First Submitted: 2016-03-03
• Results First Submitted QC: 2016-03-03
• Last Update Submitted: 2016-03-03
• Results First Posted: 2016-04-04
• Last Update Posted: 2016-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dabigatran	Dabigatran 75 mg	-
Dabigatran	Dabigatran 150 mg	-

Primary Outcome Measures

Name	Time	Method
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	Proportion of subjects receiving different types of interventions (i.e., medication / procedure and surgery) to manage the index events until their hospital discharge / release.
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	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 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%.
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 with index event safety outcomes (resolved / recovery ongoing / deceased) at the time of their hospital discharge / release.

Trial Locations

Locations (5)

1160.200.01 Boehringer Ingelheim Investigational Site; 🇺🇸 Brooklyn, New York, United States

1160.200.05 Boehringer Ingelheim Investigational Site; 🇺🇸 Stony Brook, New York, United States

1160.200.06 Boehringer Ingelheim Investigational Site; 🇺🇸 Boston, Massachusetts, United States

1160.200.02 Boehringer Ingelheim Investigational Site; 🇺🇸 Boston, Massachusetts, United States

1160.200.03 Boehringer Ingelheim Investigational Site; 🇺🇸 Austin, Texas, United States