Protein C Deficiency
Conditions
Brief summary
The overall objective is to collect and assess data on the treatment, safety, and treatment outcomes of subjects prescribed, receiving and participating in the Ceprotin treatment registry.
Interventions
BIOLOGICALProtein C Concentrate (Human)
Commercially available Ceprotin will be prescribed, obtained and administered by the investigator according to local standard of care.
Sponsors
UDC Rare Bleeding and Clotting Disorders Working Group (RBDWG)
American Thrombosis and Hemostasis Network
Baxalta now part of Shire
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Participants for whom CEPROTIN therapy has been indicated and meeting the following criteria may be enrolled in this study: * Signed and dated informed consent from either the participant or the participant's legally authorized representative prior to enrollment, as applicable * Males and females of any age, including neonates, children, adolescents and adults * Participant who received CEPROTIN or is initiating/receiving CEPROTIN treatment
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Medical diagnoses associated with Ceprotin treatment | 2 to 5 years, or until the Registry is terminated |
| Ceprotin treatment regimens | 2 to 5 years, or until the Registry is terminated |
| Safety information based on all serious adverse events (SAEs), related SAEs and related non-serious adverse events (AEs) | 2 to 5 years, or until the Registry is terminated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment outcomes categorized by medical diagnosis | 2 to 5 years, or until the Registry is terminated | Evidence of halting or reversal of coagulopathy or thrombosis, end-organ damage, limb sparing, Length of Hospital Stay (LOS), and mortality |
| CEPROTIN use and treatment outcomes in pregnancy, labor and delivery, surgery and invasive procedures, different age groups, and, in the presence of pre-existing renal and/or hepatic dysfunction | 2 to 5 years, or until the Registry is terminated | — |
Countries
Austria, Germany, Italy, Netherlands, United Kingdom, United States
Outcome results
None listed