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

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the understanding that consent may be withdrawn by the subject at any time without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