Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cross-sectional
Other

Non-interventional study design, other

Hemovigilance
Study drug and medical condition

Name of medicine, other

INTERCEPT Blood System
Population studied

Age groups

Preterm newborn infants (0 – 27 days)
Term newborn infants (0 – 27 days)
Infants and toddlers (28 days – 23 months)
Children (2 to < 12 years)
Adolescents (12 to < 18 years)
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

Hepatic impaired
Immunocompromised
Pregnant women
Renal impaired

Estimated number of subjects

500
Study design details

Main study objective

The primary objective of this non-interventional post-market clinical follow-up study is to proactively collect safety data from a wide-variety of patients (male, female, all ages) transfused with INTERCEPT Platelet and INTERCEPT Plasma components in routine therapeutic use.

Outcomes

Proportions of patients and transfusions with TRs and STRs assessed as possibly, probably (likely), or certainly (definitely) related to the transfusion of INTERCEPT Platelet or INTERCEPT Plasma components.

Data analysis plan

Data will be summarized descriptively, by component type (platelet or plasma), by site and across all sites, without formal hypothesis testing. A 95% confidence interval for the binary endpoints (e.g. proportion of patients with any TRs) will be provided for each type of study product. Data analysis will be performed on a per patient and per-transfusion basis. Subgroup analysis by age group and sex will also be presented if subgroups contain sufficient numbers of patients. TRs and STRs may also be summarized based on their temporal relationship with the transfusion of non-INTERCEPT products.