Safety clinical outcomes associated with the use of Idarucizumab for severe bleeding/emergency surgery: an observational population based study (Idarucizumab use)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Safety study (incl. comparative)
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (B01AE07) dabigatran etexilate

  (B01AF01) rivaroxaban

  (B01AF02) apixaban

  (B01AF03) edoxaban

  (V03AB37) idarucizumab

Population studied

• Short description of the study population:
  The study population will include adults (≥45 years old) under dabigatran treatment (ATC code: B01AE07) with emergency department access/hospitalization within the period January 1st, 2015 and December 31st, 2020. The date of emergency department access/hospitalization will be considered as index date to define the patient’s clinical characteristics and exposure assessment.; ; Inclusion criteria; • All individuals aged ≥ 45 years;; • Actively registered in the demographic registry at least one year prior to the index date;; • Emergency department access/hospitalization due to life-threatening bleeding or due to surgery or other invasive procedures that could not be delayed and for which normal haemostasis was required; ; Exclusion criteria; • Use of dabigatran less than 90 days before the index date;; • Patients with less than 2 years of lookback prior the index date.
• Age groups:
  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  2000

Study design details

• Main study objective:
  To describe (1) the risk of hospital mortality among idarucizumab treated individuals compared to non-treated individuals, (2) the length of hospitalization among idarucizumab treated individuals compared to non-treated individuals, (3) the risk of 30 days all-cause re-hospitalization among idarucizumab treated individuals compared to non-treated individuals
• Outcomes:
  To describe (1) risk of hospital mortality among idarucizumab treated individuals compared to untreated individuals, (2) length of hospitalization among idarucizumab treated individuals compared to untreated individuals, (3) thirty-day all-cause re-hospitalization risk in idarucizumab treated and untreated individuals
• Data analysis plan:
  • The relationship between idarucizumab status and in-hospital mortality will be estimated by using univariate and multivariate logistic regression model. The results will be expressed as Odds Ratio (OR) with 95% confidence intervals (95%CI) • The relationship between idarucizumab status and re-hospitalization, within 30 days, for any reasons will be estimated by using a Cox proportional hazard model with competing risk with death as the competing risk factor. Results will be expressed as unadjusted and adjusted Hazard Ratio (HR) with 95% confidence intervals (95%CI) • The relationship between idarucizumab status and length of hospital stay will be estimated by using a general linear regression model with negative binomial distribution. The results will be expressed as Incidence Rate Ratio (IRR) with 95%CI