Hemorrhage
Conditions
Brief summary
Idarucizumab is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran with very high affinity. Idarucizumab potently and specifically binds to dabigatran and its metabolites and neutralises its anticoagulant effect. A clinical development program is ongoing to support marketing authorisation submissions for idarucizumab indicated in patients treated with dabigatran who require emergency surgery/urgent procedures or who have a life-threatening or uncontrolledbleeding when rapid reversal of the anticoagulant effects of dabigatran is required.
Detailed description
Purpose: Study Design:
Interventions
DRUGidarucizumab
drug
Sponsors
Boehringer Ingelheim
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, \<18 years of age * Were administered idarucizumab at sites and usage identified by various methods (eg.through the Idarucizumab drug administration surveillance program, spontaneous reporting)
Exclusion criteria
Participation in a dabigatran or idarucizumab clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety outcomes until hospital discharge * Cause of death and in-hospital mortality rate | Up to 33 months |
| Safety outcomes until hospital discharge * Incidence of thromboembolic events (ie. obstruction of a blood vessel by the formation of a thrombus - e.g. ischemic stroke, MI, DVT, PE) after administration | Up to 33 months |
| Safety outcomes until hospital discharge * Incidence of hypersensitivity/anaphylactic reactions | Up to 33 months |
| Safety outcomes until hospital discharge * Incidence of AE, SAE, ADR, SADR reporting | Up to 33 months |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of patient characteristics of paediatric patients with & without outcome events * Incidence of thromboembolic events (ie. obstruction of a blood vessel by the formation of a thrombus - e.g. ischemic stroke, MI, DVT, PE) after administration | Up to 33 months |
| Comparison of patient characteristics of paediatric patients with & without outcome events * Incidence of hypersensitivity/anaphylactic reactions | Up to 33 months |
| Comparison of patient characteristics of paediatric patients with & without outcome events * Incidence of AE, SAE, ADR, SADR reporting | Up to 33 months |
| Comparison of patient characteristics of paediatric patients with & without outcome events * Cause of death and in-hospital mortality rate | Up to 33 months |
Outcome results
None listed