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

Octapharma

Status: Terminated

Conditions: Endstage Liver Disease; Coagulopathy

Treatments: Biological: Plasma; Biological: Octaplas™

Study type: Observational

Funder types: Industry

Identifiers

NCT02037373

LAS-215

Details and patient eligibility

About

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).

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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procedure is to be performed that is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudicing future medical care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

Trial design

43 participants in 2 patient groups

Octaplas™

Description:

Patients treated with Octaplas™ infusion solution for IV administration as prescribed by their treating physician.

Treatment:

Biological: Octaplas™

Plasma

Description:

Patients treated with regular plasma (e.g., fresh frozen plasma (FFP) and other FDA and American Association of Blood Banks (AABB) approved plasma products).

Treatment:

Biological: Plasma