Evaluation of the Safety of Octaplas™ Versus Plasma in Patients Undergoing Orthotopic Liver Transplantation

Study Overview
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Brief Summary
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Post-Marketing Requirement study to evaluate the safety of octaplas™ versus plasma in patients undergoing orthotopic liver transplantation (OLT). The primary objective is to assess the incidence of hyperfibrinolysis in patients undergoing (OLT) receiving octaplas™ versus regular plasma (e.g., fresh frozen plasma and other FDA and AABB approved plasma products).

Official Title
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Post-Marketing Requirement Study to Evaluate the Safety of Octaplas™ Versus Plasma in Patients Undergoing Orthotopic Liver Transplantation With Special Emphasis on Hyperfibrinolysis.

Conditions
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Coagulopathy, Endstage Liver Disease

Intervention / Treatment
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* Biological: Octaplas™
* Biological: Plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female age ≥18 years Patient is scheduled to undego orthotopic liver transplantation (OLT) Patient has a natural MAYO End-Stage Liver Disease (MELD) score of 15-40 Patient is willing to give voluntary written informed consent before any study- related procedure is to be performed that is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudicing future medical care Exclusion Criteria: Patient has a history of severe hypersensitivity reaction to plasma-derived products or to any excipient of the investigational product Patient is known to be IgA deficient with documented antibodies against IgA Patient is a planned recipient for a living donor OLT Patient has a severe deficiency of Protein S Patient is currently participating in an interventional clinical study or has participated in one within 30 days of the date of their OLT

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Octaplas™<br>Patients treated with Octaplas™ infusion solution for IV administration as prescribed by their treating physician. | Biological: Octaplas™<br>* Octaplas™ infusion solution for IV administration as prescribed by the treating physician.<br>|
| Plasma<br>Patients treated with regular plasma (e.g., fresh frozen plasma (FFP) and other FDA and American Association of Blood Banks (AABB) approved plasma products). | Biological: Plasma<br>* Plasma as prescribed by the treating physician.<br>* Other names: FFP and other approved plasma products;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the incidence of hyperfibinolysis in patients undergoing OLT receiving octaplas™ versus regular plasma (e.g., fresh frozen plasma (FFP) and other FDA and American Association of Blood Banks (AABB) approved plasma products). | The incidence of 'clinically relevant hyperfibrinolytic events' in patients receiving octaplas™ will be compared with the incidence rate in patients receiving plasma. For this trial a 'clinically relevant hyperfibrinolytic event' is defined as a decrease of at least 7.5% in the maximum amplitude (MA) as measured by the thromboelastography (TEG) or rotational thromboelastography (ROTEM) within 30 minutes after MA is achieved and the event is associated with bleeding requiring intervention. | 3 days (perioperative period plus post-operative follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety of octaplas™ in comparison to plasma will be assessed by monitoring the occurrence of adverse drug reactions (i.e., transfusion reactions). | The incidence of all adverse drug reactions (i.e., transfusion reactions) during the study period among patients receiving octaplas™ in comparison to standard plasma products. | 3 days (perioperative period plus post-operative follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intra and post-op coagulopathy in patients undergoing OLT