Trial Outcomes & Findings for Management of Major Bleeding Events in Atrial Fibrillation Patients Using Pradaxa (NCT NCT02149303)
NCT ID: NCT02149303
Last Updated: 2016-04-04
Results Overview
Proportion of subjects with index event safety outcomes (resolved / recovery ongoing / deceased) at the time of their hospital discharge / release.
Recruitment status
COMPLETED
Target enrollment
191 participants
Primary outcome 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
Results posted on
2016-04-04
Participant Flow
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.
Participant milestones
| Measure |
Dabigatran Etexilate (Pradaxa®)
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.
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|---|---|
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Overall Study
STARTED
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191
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Overall Study
COMPLETED
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191
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Management of Major Bleeding Events in Atrial Fibrillation Patients Using Pradaxa
Baseline characteristics by cohort
| Measure |
Dabigatran Etexilate (Pradaxa®)
n=191 Participants
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.
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|---|---|
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Age, Continuous
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77.6 years
STANDARD_DEVIATION 10.20 • n=5 Participants
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Sex: Female, Male
Female
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93 Participants
n=5 Participants
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Sex: Female, Male
Male
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98 Participants
n=5 Participants
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PRIMARY outcome
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 daysPopulation: Patients who received treatment at the five study sites
Proportion of subjects with index event safety outcomes (resolved / recovery ongoing / deceased) at the time of their hospital discharge / release.
Outcome measures
| Measure |
Dabigatran Etexilate (Pradaxa®)
n=191 Participants
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.
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|---|---|
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Proportion of Subjects With Index Event Safety Outcomes (Resolved / Recovery Ongoing / Deceased) at the Time of Their Hospital Discharge / Release.
Resolved at discharge
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86.4 Percentage of participants
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Proportion of Subjects With Index Event Safety Outcomes (Resolved / Recovery Ongoing / Deceased) at the Time of Their Hospital Discharge / Release.
Unresolved at discharge (Recovery ongoing)
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7.3 Percentage of participants
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Proportion of Subjects With Index Event Safety Outcomes (Resolved / Recovery Ongoing / Deceased) at the Time of Their Hospital Discharge / Release.
Died before discharge (Deceased)
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6.3 Percentage of participants
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PRIMARY outcome
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 daysPopulation: Patients who received treatment at the five study sites
Proportion of subjects receiving different types of interventions (i.e., medication / procedure and surgery) to manage the index events until their hospital discharge / release.
Outcome measures
| Measure |
Dabigatran Etexilate (Pradaxa®)
n=191 Participants
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.
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|---|---|
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Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release
Fluid transfusion
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72.8 Percentage of participants
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Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release
Blood transfusion
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57.1 Percentage of participants
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Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release
Fresh frozen plasma (FFP)
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24.6 Percentage of participants
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Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release
Plasma cryoprecipitate
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1.6 Percentage of participants
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Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release
Platelets
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5.8 Percentage of participants
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Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release
Blood coagulation factor concentrates
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5.8 Percentage of participants
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Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release
Computed tomography (CT) scanning
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39.3 Percentage of participants
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Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release
X-ray
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24.1 Percentage of participants
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Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release
Upper endoscopy
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20.9 Percentage of participants
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Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release
Colonoscopy
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19.9 Percentage of participants
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Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release
Endoscopy (unspecified whether lower or upper)
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6.3 Percentage of participants
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Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release
Nuclear imaging
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5.8 Percentage of participants
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Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release
Ultrasound
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5.8 Percentage of participants
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Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release
Magnetic resonance imaging (MRI)
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3.7 Percentage of participants
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Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release
Enteroscopy
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1.6 Percentage of participants
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Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release
Sigmoidoscopy
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1.6 Percentage of participants
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Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release
Surgery or procedure
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26.7 Percentage of participants
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Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release
Drugs for the alimentary tract
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32.5 Percentage of participants
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Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release
Blood/anticoagulant medication
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7.9 Percentage of participants
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Proportion of Subjects Receiving Different Types of Interventions (i.e., Medication / Procedure and Surgery) to Manage the Index Events Until Their Hospital Discharge / Release
Vitamin K
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3.7 Percentage of participants
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PRIMARY outcome
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 daysPopulation: Patients who received treatment at the five study sites
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%.
Outcome measures
| Measure |
Dabigatran Etexilate (Pradaxa®)
n=191 Participants
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.
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|---|---|
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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
Gastrointestinal
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61.8 Percentage of events
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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
Upper tract
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22.5 Percentage of events
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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
Lower tract
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34.0 Percentage of events
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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
Brain / Intracranial
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18.8 Percentage of events
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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
Other
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18.8 Percentage of events
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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
Non-trauma
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4.2 Percentage of events
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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
Trauma
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14.7 Percentage of events
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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
Fall
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14.1 Percentage of events
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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
Motor vehicle accident
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0.5 Percentage of events
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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
Unknown
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0.5 Percentage of events
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Adverse Events
Dabigatran Etexilate (Pradaxa®)
Serious events: 11 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dabigatran Etexilate (Pradaxa®)
n=191 participants at risk
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.
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|---|---|
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Blood and lymphatic system disorders
Anaemia
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0.52%
1/191 • 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
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Cardiac disorders
Cardiac failure congestive
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1.0%
2/191 • 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
|
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
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0.52%
1/191 • 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
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
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0.52%
1/191 • 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
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Nervous system disorders
Haemorrhage intracranial
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0.52%
1/191 • 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
|
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Nervous system disorders
Subarachnoid haemorrhage
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0.52%
1/191 • 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
|
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Psychiatric disorders
Suicide attempt
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0.52%
1/191 • 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
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Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
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0.52%
1/191 • 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
|
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Respiratory, thoracic and mediastinal disorders
Lung disorder
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0.52%
1/191 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
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0.52%
1/191 • 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
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
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0.52%
1/191 • 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
|
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Vascular disorders
Thrombosis
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0.52%
1/191 • 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
|
Other adverse events
| Measure |
Dabigatran Etexilate (Pradaxa®)
n=191 participants at risk
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.
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|---|---|
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Blood and lymphatic system disorders
Anaemia
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17.8%
34/191 • 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
|
|
Gastrointestinal disorders
Diverticulum
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7.3%
14/191 • 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
|
|
Gastrointestinal disorders
Haemorrhoids
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6.8%
13/191 • 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
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER