Clinical Trial: Ceprotin Treatment Registry
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Ceprotin Treatment Registry
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.
Detailed Summary:
Sponsor: Baxalta US Inc.
Current Primary Outcome:
- Medical diagnoses associated with Ceprotin treatment [ Time Frame: 2 to 5 years, or until the Registry is terminated ]
- Ceprotin treatment regimens [ Time Frame: 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) [ Time Frame: 2 to 5 years, or until the Registry is terminated ]
Original Primary Outcome:
- Medical diagnoses associated with Ceprotin treatment [ Time Frame: June 2015 ]
- Ceprotin treatment regimens [ Time Frame: June 2015 ]
- Safety information based on serious adverse events and all related adverse events [ Time Frame: June 2015 ]
Current Secondary Outcome:
- Treatment outcomes categorized by medical diagnosis [ Time Frame: 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 [ Time Frame: 2 to 5 years, or until the Registry is terminated ]
Original Secondary Outcome:
Information By: Baxalta US Inc.
Dates:
Date Received: April 16, 2010
Date Started: June 2010
Date Completion:
Last Updated: July 10, 2015
Last Verified: July 2015
