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).
Study Type
OBSERVATIONAL
Enrollment
43
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
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.
Time frame: 3 days (perioperative period plus post-operative follow-up)
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.
Time frame: 3 days (perioperative period plus post-operative follow-up)
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