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

Launched by OCTAPHARMA · Jan 14, 2014

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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procedure is to be performed that is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudicing future medical care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