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

Terminated

• Conditions: Coagulopathy; Endstage Liver Disease
• Interventions: Biological: Octaplas™; Biological: Plasma

• Registration Number: NCT02037373
• Lead Sponsor: Octapharma

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-14
• Study First Posted: 2014-01-15
• Study Start: 2015-08
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-05
• Last Update Posted: 2018-03-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 43

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procedure is to be performed that is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudicing future medical care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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Octaplas™	Octaplas™	Patients treated with Octaplas™ infusion solution for IV administration as prescribed by their treating physician.
Plasma	Plasma	Patients treated with regular plasma (e.g., fresh frozen plasma (FFP) and other FDA and American Association of Blood Banks (AABB) approved plasma products).

Primary Outcome Measures

Name	Time	Method
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).	3 days (perioperative period plus post-operative follow-up)	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.

Secondary Outcome Measures

Name	Time	Method
The safety of octaplas™ in comparison to plasma will be assessed by monitoring the occurrence of adverse drug reactions (i.e., transfusion reactions).	3 days (perioperative period plus post-operative follow-up)	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.

Trial Locations

Locations (1)

Octapharma Research Site; 🇺🇸 Nashville, Tennessee, United States