Clinical trial NCT02037373: Evaluation of the Safety of Octaplas™ Versus Plasma in Patients Undergoing Orthotopic Liver Transplantation
Official title: Post-Marketing Requirement Study to Evaluate the Safety of Octaplas™ Versus Plasma in Patients Undergoing Orthotopic Liver Transplantation With Special Emphasis on Hyperfibrinolysis.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coagulopathy
Endstage Liver Disease
Keywords: intra and post-op coagulopathy in patients undergoing OLT
Lead sponsor: Octapharma
Sponsor class: INDUSTRY
First posted: 2014-01-15
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will include patients undergoing orthotopic liver transplantation

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).


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procedure is to be performed that is not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudicing future medical care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

Primary outcomes:
measure: 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).
timeFrame: 3 days (perioperative period plus post-operative follow-up)
Secondary outcomes:
measure: The safety of octaplas™ in comparison to plasma will be assessed by monitoring the occurrence of adverse drug reactions (i.e., transfusion reactions).
timeFrame: 3 days (perioperative period plus post-operative follow-up)
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Octapharma Research Site
state: California
city: Philadelphia
country: United States
facility: Octapharma Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Octapharma Research Site
state: Pennsylvania
city: Nashville
country: United States
facility: Octapharma Research Site
state: Tennessee
Study officials:
affiliation: International Medical Monitor
name: Wolfgang Frenzel
role: STUDY_DIRECTOR
References: