An observational cohort study of the risk of thromboembolic events among adult patients treated with KCENTRA® compared with plasma for urgent reversal of vitamin K antagonist therapy in the setting of acute major bleeding (REVERSAL)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Kcentra
• Medical condition to be studied:
  Haemorrhage

  Haemorrhagic disorder

Population studied

• Short description of the study population:
  Adult patients treated with KCENTRA® and plasma for urgent reversal of vitamin K antagonist therapy in the setting of acute major bleeding.
• 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:
  2875

Study design details

• Main study objective:
  To estimate the risk of confirmed TEE within 45 days after the index date for patients treated with KCENTRA compared to patients treated with plasma among those without a recent history of TEE.
• Outcomes:
  Risk of thromboembolic events (TEE) for patients without a recent history of TEE, Risk of thromboembolic events,Risk of death from any cause
• Data analysis plan:
  Incidence rates with associated 95% confidence intervals will be calculated for each outcome of interest by treatment type. Multivariable analyses will be conducted to examine the independent association between treatment type and each outcome of interest, with adjustment for relevant potential confounders and cluster effects, as well as possible time-dependent confounding.