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.
Study Type
OBSERVATIONAL
Enrollment
445
Intravenous infusion, the dosage and the frequency of administration is calculated on an individual patient basis.
FFP is administered before Beriplex® P/N. Each treatment is given as an intravenous infusion, with the dosage of each calculated on an individual patient basis.
Intravenous infusion, the dosage and the frequency of administration is calculated on an individual patient basis.
Royal Blackburn Hospital
Blackburn, United Kingdom
Blackpool
Blackpool, United Kingdom
Addenbrokes
Cambridge, United Kingdom
Royal Free Hospital
London, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Southhampton General Hospital
Southhampton, United Kingdom
Adequacy of stopping or preventing bleeding
Time frame: Up to 24 hours after treatment
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
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