Clinical Trial: Observational Study of Prophylaxis and Treatment of Acute Perioperative Bleeding With Beriplex® P/N (Probe Study)
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Non-interventional Observational Study of Beriplex® P/N in Prophylaxis and Treatment of Acute Bleeding Perioperatively (Diagnostic Intervention or Surgery)
Brief Summary: Beriplex® P/N is made from human plasma (the liquid part of the blood) and contains the coagulation factors II, VII, IX and X which are important for blood clotting (coagulation). Lack of any of these factors means that blood does not clot as quickly as it should and so there is an increased tendency to bleed. This observational study was designed to evaluate the effectiveness of Beriplex® P/N in the prevention (prophylaxis) and treatment of bleeding during surgery (perioperative bleeding) in a routine clinical setting.
Detailed Summary:
Sponsor: CSL Behring
Current Primary Outcome: Adequacy of stopping or preventing bleeding [ Time Frame: Up to 24 hours after treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Transfusions required [ Time Frame: Up to 24 hours after treatment ]
- Clinical trigger for administration of the intervention [ Time Frame: Up to 24 hours after treatment ]
- Mortality [ Time Frame: Up to 24 hours after treatment ]
- International normalized ratio (INR) [ Time Frame: From 3 hours before and up to 24 hours after treatment ]
- Prothrombin time (PT) [ Time Frame: From 3 hours before and up to 24 hours after treatment ]
- Receipt of other blood products and /or hemostatic agents [ Time Frame: Up to 24 hours after treatment ]
- Vital signs [ Time Frame: From 3 hours before and up to 24 hours after treatment ]
Original Secondary Outcome: Same as current
Information By: CSL Behring
Dates:
Date Received: January 20, 2010
Date Started: May 2010
Date Completion:
Last Updated: June 13, 2012
Last Verified: June 2012
