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

Launched by CSL BEHRING · Jan 20, 2010

Keywords

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Gender

ALL

Eligibility criteria

• 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)