NCT01053169

Observational Study of Prophylaxis and Treatment of Acute Perioperative Bleeding With Beriplex® P/N (Probe Study)

Non-interventional Observational Study of Beriplex® P/N in Prophylaxis and Treatment of Acute Bleeding Perioperatively (Diagnostic Intervention or Surgery)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 445 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coagulation Protein Disorders
• Blood Loss, Surgical
• Perioperative Care

Interventions

Type	Name	Description
BIOLOGICAL	Beriplex® P/N	Intravenous infusion, the dosage and the frequency of administration is calculated on an individual patient basis.
BIOLOGICAL	Fresh Frozen Plasma (FFP) and Beriplex® P/N	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.
OTHER	Fresh Frozen Plasma	Intravenous infusion, the dosage and the frequency of administration is calculated on an individual patient basis.

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2010-01-21
• Last updated: 2017-10-03

Locations

6 sites across 1 country: United Kingdom