A retrospective cohort study with chart review to assess the management of major bleeding events in NVAF patients treated with dabigatran etexilate

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Assessment of management of major bleeding

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Atrial fibrillation

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  The objective of this non interventional study is to assess the clinical characteristics of major bleeding events in patients with NVAF taking dabigatran who present to emergency departments/emergency rooms or who are hospitalized in-patients for management of such events.
• Outcomes:
  1) Number of patients with index event (ongoing/resolved/deceased) at time of hospital discharge/release, 2) Frequencies of patients receiving different types of interventions to stop index event until hospital discharge and 3) Frequencies of bleeding types and anatomic locations of the index events at time of ED/ER presentation.
• Data analysis plan:
  Descriptive analyses frequencies, means, standard deviations, medians, ranges, minimum and maximum values, 95% confidence intervals and proportions, as appropriate) of patient characteristics, bleeding sources, diagnostic approaches, type of interventions for treatment of bleeding and outcome of the interventions overall and by relevant demographic and intervention subgroups supplemented with a compilation of narratives describing the bleeding. Narratives will be generated from a standard template into which data will be entered from the database.Subgroup analyses of interest will be based upon pertinent clinical criteria such as age, sex, body-mass index, dabigatran etexilate dose (and retrospective determination of appropriateness of dose), treatment duration, concomitant medications (specifically antiplatelet agents and P-glycoprotein (P-gp) inhibitors), past medical history (e.g. prior history of bleeding events), and renal function.