Blood Loss, Surgical, Coagulation Protein Disorders, Perioperative Care
Conditions
Keywords
Coagulopathy, Perioperative bleeding, Prothrombin complex, Liver disease
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.
Interventions
BIOLOGICALBeriplex® P/N
Intravenous infusion, the dosage and the frequency of administration is calculated on an individual patient basis.
BIOLOGICALFresh 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.
OTHERFresh Frozen Plasma
Intravenous infusion, the dosage and the frequency of administration is calculated on an individual patient basis.
Sponsors
CSL Behring
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(All): For all cohorts: •≥ 16 years of age * Received treatment with: * Beriplex® P/N * or FFP and Beriplex® P/N (in subsequent order) * or FFP only * INR and/or PT results available in connection with administration of Beriplex® P/N or FFP: * within 3 hours directly before and after administration of Beriplex® P/N or FFP In case of Beriplex® P/N use subsequent to FFP, additional results of INR and PT between the administration of the two products Cohort P (Prophylaxis Group): * Chronic liver disease, acute liver failure, or other conditions requiring correction of coagulopathy * Coagulopathy (INR \> 1.4 and/or PT ≥ 3 sec of upper limit of normal \[ULN\]) * Any planned major or minimally invasive procedure, except liver transplantation Cohort T (Treatment Group): * Acute perioperative bleeding (as assessed by the investigator)
Exclusion criteria
* Treatment with prothrombin complex concentrates (PCCs) other than Beriplex® P/N * Acquired deficiency of the vitamin K-dependent coagulation factors (e.g., as induced by treatment with oral vitamin K antagonists)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adequacy of stopping or preventing bleeding | Up to 24 hours after treatment |
Secondary
| Measure | Time frame |
|---|---|
| Clinical trigger for administration of the intervention | Up to 24 hours after treatment |
| Mortality | Up to 24 hours after treatment |
| International normalized ratio (INR) | From 3 hours before and up to 24 hours after treatment |
| Transfusions required | Up to 24 hours after treatment |
| Receipt of other blood products and /or hemostatic agents | Up to 24 hours after treatment |
| Vital signs | From 3 hours before and up to 24 hours after treatment |
| Prothrombin time (PT) | From 3 hours before and up to 24 hours after treatment |
Countries
United Kingdom
Outcome results
None listed