Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT01053169
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT01053169
Study Brief:
Protocol Section:
NCT01053169