Study type

Study topic

Disease /health condition

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cross-sectional
Study drug and medical condition

Medical condition to be studied

Haemorrhagic disorder
Population studied

Short description of the study population

Adult patients(≥18 years).Cases were identified in 2 EDs of the Hospital ofVerona (population of about 300,000 inhabitants).All patients accessing from 1 February 2015 to 31 July 2015 and from 1 February 2016 to 31 July 2016,having an International Classification of Diseases, Clinical Modification code of discharge related to haemorrhage without concomitant diagnosis of trauma,were included

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

118000
Study design details

Main study objective

Our aims were to describe the incidence of haemorrhages and adversedrug events (ADEs) related to different classes of drugs as cause of ED admission, the characteristics of patients, the kind of bleeding and thedescription of hospitalizations and intra-hospital deaths.

Outcomes

To estimate the incidence of hemorrhagic patients entering theemergency department during the study period

Data analysis plan

To estimate the incidence of hemorrhagic patients entering theemergency department during the study period we calculated the ratiobetween the patients with an ICD-9 DM diagnosis that code for ahaemorrhage respect to all patients who entered in the same period.Descriptive baseline characteristics were expressed in percentages andmeans ± standard deviation of the mean. Data about hemorrhage anddrugs are presented as percentage since they are categorical variables.