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Trial record 89 of 332 for:    DABIGATRAN

Management of Major Bleeding Events in Atrial Fibrillation Patients Using Pradaxa

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ClinicalTrials.gov Identifier: NCT02149303
Recruitment Status : Completed
First Posted : May 29, 2014
Results First Posted : April 4, 2016
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Conditions Atrial Fibrillation
Hemorrhage
Interventions Drug: Dabigatran 75 mg
Drug: Dabigatran 150 mg
Enrollment 191
Recruitment Details This is a retrospective observational study. 284 subjects were captured in the initial screening. 93 subjects were found not to meet the eligibility criteria and were excluded from the study, leaving 191 subjects eligible for study entry who were enrolled and included in the final study.
Pre-assignment Details  
Arm/Group Title Dabigatran Etexilate (Pradaxa®)
Hide Arm/Group Description Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
Period Title: Overall Study
Started 191
Completed 191
Not Completed 0
Arm/Group Title Dabigatran Etexilate (Pradaxa®)
Hide Arm/Group Description Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
Overall Number of Baseline Participants 191
Hide Baseline Analysis Population Description
Patients who received treatment at the five study sites.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 191 participants
77.6  (10.20)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 191 participants
Female
93
  48.7%
Male
98
  51.3%
1.Primary Outcome
Title Proportion of Subjects With Index Event Safety Outcomes (Resolved / Recovery Ongoing / Deceased) at the Time of Their Hospital Discharge / Release.
Hide Description Proportion of subjects with index event safety outcomes (resolved / recovery ongoing / deceased) at the time of their hospital discharge / release.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who received treatment at the five study sites
Arm/Group Title Dabigatran Etexilate (Pradaxa®)
Hide Arm/Group Description:
Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
Overall Number of Participants Analyzed 191
Measure Type: Number
Unit of Measure: Percentage of participants
Resolved at discharge 86.4
Unresolved at discharge (Recovery ongoing) 7.3
Died before discharge (Deceased) 6.3
2.Primary Outcome
Title Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release
Hide Description Proportion of subjects receiving different types of interventions (i.e., medication / procedure and surgery) to manage the index events until their hospital discharge / release.
Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who received treatment at the five study sites
Arm/Group Title Dabigatran Etexilate (Pradaxa®)
Hide Arm/Group Description:
Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
Overall Number of Participants Analyzed 191
Measure Type: Number
Unit of Measure: Percentage of participants
Fluid transfusion 72.8
Blood transfusion 57.1
Fresh frozen plasma (FFP) 24.6
Plasma cryoprecipitate 1.6
Platelets 5.8
Blood coagulation factor concentrates 5.8
Computed tomography (CT) scanning 39.3
X-ray 24.1
Upper endoscopy 20.9
Colonoscopy 19.9
Endoscopy (unspecified whether lower or upper) 6.3
Nuclear imaging 5.8
Ultrasound 5.8
Magnetic resonance imaging (MRI) 3.7
Enteroscopy 1.6
Sigmoidoscopy 1.6
Surgery or procedure 26.7
Drugs for the alimentary tract 32.5
Blood/anticoagulant medication 7.9
Vitamin K 3.7
3.Primary Outcome
Title 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
Hide Description

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%.

Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who received treatment at the five study sites
Arm/Group Title Dabigatran Etexilate (Pradaxa®)
Hide Arm/Group Description:
Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
Overall Number of Participants Analyzed 191
Measure Type: Number
Unit of Measure: Percentage of events
Gastrointestinal 61.8
Upper tract 22.5
Lower tract 34.0
Brain / Intracranial 18.8
Non-trauma 4.2
Trauma 14.7
Fall 14.1
Motor vehicle accident 0.5
Unknown 0.5
Other 18.8
Time Frame 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
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dabigatran Etexilate (Pradaxa®)
Hide Arm/Group Description Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
All-Cause Mortality
Dabigatran Etexilate (Pradaxa®)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dabigatran Etexilate (Pradaxa®)
Affected / at Risk (%)
Total   11/191 (5.76%) 
Blood and lymphatic system disorders   
Anaemia  1  1/191 (0.52%) 
Cardiac disorders   
Cardiac failure congestive  1  2/191 (1.05%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Hepatic cancer  1  1/191 (0.52%) 
Neoplasm malignant  1  1/191 (0.52%) 
Nervous system disorders   
Haemorrhage intracranial  1  1/191 (0.52%) 
Subarachnoid haemorrhage  1  1/191 (0.52%) 
Psychiatric disorders   
Suicide attempt  1  1/191 (0.52%) 
Respiratory, thoracic and mediastinal disorders   
Acute pulmonary oedema  1  1/191 (0.52%) 
Lung disorder  1  1/191 (0.52%) 
Pulmonary congestion  1  1/191 (0.52%) 
Respiratory failure  1  1/191 (0.52%) 
Vascular disorders   
Thrombosis  1  1/191 (0.52%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dabigatran Etexilate (Pradaxa®)
Affected / at Risk (%)
Total   50/191 (26.18%) 
Blood and lymphatic system disorders   
Anaemia  1  34/191 (17.80%) 
Gastrointestinal disorders   
Diverticulum  1  14/191 (7.33%) 
Haemorrhoids  1  13/191 (6.81%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI’s intellectual property rights
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 800-243-0127 ext +1
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02149303     History of Changes
Other Study ID Numbers: 1160.200
First Submitted: May 19, 2014
First Posted: May 29, 2014
Results First Submitted: March 3, 2016
Results First Posted: April 4, 2016
Last Update Posted: April 4, 2016