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

Stopped early

Conditions studied: Coagulopathy, Endstage Liver Disease

In brief

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).

Key facts

Study ID

NCT02037373

Run by

Octapharma

People needed

43

Starts

2015-08-01

Expected to finish

2018-02-01

Last updated by the study team

2018-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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procedure is to be performed that is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudicing future medical care

You may not qualify if…

• 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

Where it is running

• Octapharma Research Site — Loma Linda, California, United States
• Octapharma Research Site — Philadelphia, Pennsylvania, United States
• Octapharma Research Site — Pittsburgh, Pennsylvania, United States
• Octapharma Research Site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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