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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/45386
• EU PAS number:
  EUPAS45385
• Study ID:
  45386
• Official title and acronym:
  Safety clinical outcomes associated with the use of Idarucizumab for severe bleeding/emergency surgery: an observational population based study (Idarucizumab use)
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  Background and Rationale The European Medicines Agency (EMA) approved a new monoclonal antibody called idarucizumab, a reversal agent for dabigatran. Findings from the pivotal trial (RE-VERSE trial) showed that idarucizumab reversed the anticoagulant effect of dabigatran in 98% of treated individuals. However, some case reports and case series reported potential rebound effect in dabigatran levels after an initial dose of the drug. So far, evidence on effectiveness and safety of idarucizumab in clinical practice is still limited. Therefore, new real-world studies are warranted to assess the relationship between idarucizumab use and safety clinical outcomes (i.e, mortality and re-hospitalization). Objectives • The risk of hospital mortality among idarucizumab treated individuals compared to non-treated individuals. • The length of hospitalization among idarucizumab treated individuals compared to non-treated individuals. • The risk of 30 days all-cause re-hospitalization among idarucizumab treated individuals compared to non-treated individuals. Study Design This will be a retrospective cohort study based on Healthcare administrative database (HAD). Methods • Baseline demographic and clinical characteristics will be reported and compared across exposure cohorts. • The relationship between idarucizumab status and in-hospital mortality will be estimated by using univariate and multivariate logistic regression model. • 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. • The relationship between idarucizumab status and length of hospital stay will be estimated by using a general linear regression model with negative binomial distribution.
• Study status:
  Finalised

Research institution and networks

Institutions

Agenzia regionale di sanità della Toscana (ARS)

Italy

Study timelines

Date when funding contract was signed

Planned: 05/03/2021

Actual: 05/03/2021

Study start date

Planned: 13/05/2021

Actual: 13/05/2021

Date of final study report

Planned: 15/12/2021

Actual: 15/12/2021

Sources of funding

Other

More details on funding

Self-funded by ARS

Study protocol

Initial protocol

Safety clinical outcomes associated with the use of Idarucizumab

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable