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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-02-28

Brief Summary

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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).

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Detailed Description

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Conditions

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Coagulopathy Endstage Liver Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Octaplas™

Patients treated with Octaplas™ infusion solution for IV administration as prescribed by their treating physician.

Octaplas™

Intervention Type BIOLOGICAL

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).

Plasma

Intervention Type BIOLOGICAL

Plasma as prescribed by the treating physician.

Interventions

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Octaplas™

Octaplas™ infusion solution for IV administration as prescribed by the treating physician.

Intervention Type BIOLOGICAL

Plasma

Plasma as prescribed by the treating physician.

Intervention Type BIOLOGICAL

Other Intervention Names

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FFP and other approved plasma products

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No