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

Post-Marketing Requirement Study to Evaluate the Safety of Octaplas™ Versus Plasma in Patients Undergoing Orthotopic Liver Transplantation With Special Emphasis on Hyperfibrinolysis.

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 Overview

• Status: Terminated
• Conditions: Coagulopathy; Endstage Liver Disease
• Intervention / Treatment: Biological: Octaplas™; Biological: Plasma

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Octapharma Research Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Octapharma Research Site
    • Pittsburgh, Pennsylvania, United States, 15232
      • Octapharma Research Site
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Octapharma Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Study population will include patients undergoing orthotopic liver transplantation

Description

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procedure is to be performed that is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudicing future medical care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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Octaplas™; Patients treated with Octaplas™ infusion solution for IV administration as prescribed by their treating physician.	Biological: Octaplas™; Octaplas™ infusion solution for IV administration as prescribed by the treating physician.
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).	Biological: Plasma; Plasma as prescribed by the treating physician.; Other Names: FFP and other approved plasma products

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 days (perioperative period plus post-operative follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 days (perioperative period plus post-operative follow-up)

Collaborators and Investigators

• Sponsor: Octapharma
• Investigators: Study Director: Wolfgang Frenzel, International Medical Monitor

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: January 14, 2014
• First Submitted That Met QC Criteria: January 14, 2014
• First Posted (Estimate): January 15, 2014

Study Record Updates

• Last Update Posted (Actual): March 7, 2018
• Last Update Submitted That Met QC Criteria: March 5, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: intra and post-op coagulopathy in patients undergoing OLT
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Liver Diseases; End Stage Liver Disease; Hemostatic Disorders; Blood Coagulation Disorders
• Other Study ID Numbers: LAS-215