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

Study Overview
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Brief Summary
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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.

Official Title
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Non-interventional Observational Study of Beriplex® P/N in Prophylaxis and Treatment of Acute Bleeding Perioperatively (Diagnostic Intervention or Surgery)

Conditions
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Coagulation Protein Disorders, Blood Loss, Surgical, Perioperative Care

Intervention / Treatment
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* Biological: Beriplex® P/N
* Biological: Fresh Frozen Plasma (FFP) and Beriplex® P/N
* Other: Fresh Frozen Plasma


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prophylaxis Cohort<br>Patients with coagulopathy due to liver disease or other condition requiring correction of coagulopathy who require surgical or diagnostic intervention | Biological: Beriplex® P/N<br>* Intravenous infusion, the dosage and the frequency of administration is calculated on an individual patient basis.<br>* Other names: Prothrombin complex concentrate;Biological: Fresh Frozen Plasma (FFP) and Beriplex® P/N<br>* 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.<br>* Other names: Prothrombin Complex Concentrate;Other: Fresh Frozen Plasma<br>* Intravenous infusion, the dosage and the frequency of administration is calculated on an individual patient basis.<br>|
| Treatment Cohort<br>Patients experiencing acute bleeding perioperatively | Biological: Beriplex® P/N<br>* Intravenous infusion, the dosage and the frequency of administration is calculated on an individual patient basis.<br>* Other names: Prothrombin complex concentrate;Biological: Fresh Frozen Plasma (FFP) and Beriplex® P/N<br>* 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.<br>* Other names: Prothrombin Complex Concentrate;Other: Fresh Frozen Plasma<br>* Intravenous infusion, the dosage and the frequency of administration is calculated on an individual patient basis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequacy of stopping or preventing bleeding |  | Up to 24 hours after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusions required |  | Up to 24 hours after treatment | 
| 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 | 
| Prothrombin time (PT) |  | From 3 hours before and 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coagulopathy, Perioperative bleeding, Prothrombin complex, Liver disease