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

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)