Observational Study of Prophylaxis and Treatment of Acute Perioperative Bleeding With Beriplex® P/N (Probe Study)
Sponsored by CSL Behring
About this trial
Last updated 8 years ago
Study ID
Status
Type
Placebo
Accepting
Not accepting
Trial Timing
Ended 14 years ago
What is this trial about?
What are the Participation Requirements?
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)