Atrial Fibrillation, Hemorrhage
Conditions
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:
Interventions
DRUGDabigatran 75 mg
PO BID
PO BID
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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%. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 191 |
| Total | 191 |
Baseline characteristics
| Characteristic | Dabigatran Etexilate (Pradaxa®) |
|---|---|
| Age, Continuous | 77.6 years STANDARD_DEVIATION 10.2 |
| Sex: Female, Male Female | 93 Participants |
| Sex: Female, Male Male | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 50 / 191 |
| serious Total, serious adverse events | 11 / 191 |
Outcome results
Primary
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%.
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
Population: Patients who received treatment at the five study sites
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran Etexilate (Pradaxa®) | 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 | 34.0 Percentage of events |
| Dabigatran Etexilate (Pradaxa®) | 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 | 18.8 Percentage of events |
| Dabigatran Etexilate (Pradaxa®) | 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 | 4.2 Percentage of events |
| Dabigatran Etexilate (Pradaxa®) | 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 | 0.5 Percentage of events |
| Dabigatran Etexilate (Pradaxa®) | 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 | 0.5 Percentage of events |
| Dabigatran Etexilate (Pradaxa®) | 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 | 61.8 Percentage of events |
| Dabigatran Etexilate (Pradaxa®) | 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 | 22.5 Percentage of events |
| Dabigatran Etexilate (Pradaxa®) | 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 | 14.7 Percentage of events |
| Dabigatran Etexilate (Pradaxa®) | 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 | 14.1 Percentage of events |
| Dabigatran Etexilate (Pradaxa®) | 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 | 18.8 Percentage of events |
Primary
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.
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
Population: Patients who received treatment at the five study sites
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran Etexilate (Pradaxa®) | 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 | 57.1 Percentage of participants |
| Dabigatran Etexilate (Pradaxa®) | 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 | 1.6 Percentage of participants |
| Dabigatran Etexilate (Pradaxa®) | 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 | 72.8 Percentage of participants |
| Dabigatran Etexilate (Pradaxa®) | 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) | 24.6 Percentage of participants |
| Dabigatran Etexilate (Pradaxa®) | 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 | 1.6 Percentage of participants |
| Dabigatran Etexilate (Pradaxa®) | 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 | 5.8 Percentage of participants |
| Dabigatran Etexilate (Pradaxa®) | 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 | 5.8 Percentage of participants |
| Dabigatran Etexilate (Pradaxa®) | 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 | 39.3 Percentage of participants |
| Dabigatran Etexilate (Pradaxa®) | 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 | 24.1 Percentage of participants |
| Dabigatran Etexilate (Pradaxa®) | 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 | 20.9 Percentage of participants |
| Dabigatran Etexilate (Pradaxa®) | 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 | 19.9 Percentage of participants |
| Dabigatran Etexilate (Pradaxa®) | 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) | 6.3 Percentage of participants |
| Dabigatran Etexilate (Pradaxa®) | 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 | 5.8 Percentage of participants |
| Dabigatran Etexilate (Pradaxa®) | 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 | 5.8 Percentage of participants |
| Dabigatran Etexilate (Pradaxa®) | 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) | 3.7 Percentage of participants |
| Dabigatran Etexilate (Pradaxa®) | 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 | 1.6 Percentage of participants |
| Dabigatran Etexilate (Pradaxa®) | 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 | 26.7 Percentage of participants |
| Dabigatran Etexilate (Pradaxa®) | 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 | 32.5 Percentage of participants |
| Dabigatran Etexilate (Pradaxa®) | 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 | 7.9 Percentage of participants |
| Dabigatran Etexilate (Pradaxa®) | 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 | 3.7 Percentage of participants |
Primary
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.
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
Population: Patients who received treatment at the five study sites
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dabigatran Etexilate (Pradaxa®) | Proportion of Subjects With Index Event Safety Outcomes (Resolved / Recovery Ongoing / Deceased) at the Time of Their Hospital Discharge / Release. | Resolved at discharge | 86.4 Percentage of participants |
| Dabigatran Etexilate (Pradaxa®) | 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) | 7.3 Percentage of participants |
| Dabigatran Etexilate (Pradaxa®) | Proportion of Subjects With Index Event Safety Outcomes (Resolved / Recovery Ongoing / Deceased) at the Time of Their Hospital Discharge / Release. | Died before discharge (Deceased) | 6.3 Percentage of participants |