Non-interventional post-authorisation safety study of pattern of use of Nordic Aprotinin (Nordic Aprotinin Patient Registry)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Post Authorisation Safety Study, Active surveillance

Study drug and medical condition

• Medicinal product name, other:
  TRASYLOL 10,000 KIU/ml, injectable solution
• Medical condition to be studied:
  Death

  Thromboembolectomy

  Myocardial infarction

  Cerebrovascular accident

  Renal failure

  Anaphylactic reaction

Population studied

• Short description of the study population:
  All patients exposed to Nordic Aprotinin at all participating cardiac surgical centre fulfilling criteria of the restricted distribution in participating countries in Europe.; ; Inclusion Criteria:; - All patients exposed to Nordic Aprotinin at all participating cardiac surgical centre fulfilling criteria of the restricted distribution in participating countries in Europe.; ; Exclusion Criteria:; - None
• 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)
• Special population of interest:
  Renal impaired

  Hepatic impaired

  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  5268

Study design details

• Main study objective:
  1. Monitor the pattern of use and record utilisation information2. Measure the incidence of the following adverse events3. Measure the effectiveness of risk minimisation measures as described in the RMP and close monitoring of adherence to the SmPC recommendations
• Outcomes:
  - Death- Myocardial infarction (fatal and non-fatal)- Renal failure (fatal and non-fatal)- Renal failure with and without aminoglycoside use- Stroke (fatal and non-fatal)- Other embolic or thrombotic event (fatal and non-fatal)- Blood loss: requiring blood product transfusion, requiring re-operation- Blood product transfusion- Anaphylaxis
• Data analysis plan:
  All data analyses will be performed by Dendrite Clinical Systems together with Nordic after the Key Data are completed. Analysed data will be reviewed by an Independent Data Safety Monitoring Committee, involving at least four national coordinating investigators.The analysis of data from the Registry will be descriptive, and all information will be reported in summary tables. Summary data will be provided for all variables collected and the data will be reported overall, by country, and if required by centre. The intention is to focus on those variables most pertinent to assessing compliance with approved labelling and instructions for appropriate use, including use ofheparin and monitoring of anticoagulation. The data will also be reviewed for any safety signals. The outcomes to be included in each report will include at least the primary outcomes. Overall reports will be synchronised with PSUR scheme and timelines.