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

NCT02037373 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 43

Last updated 2018-03-07

No results posted yet for this study

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).

Conditions

  • Coagulopathy
  • Endstage Liver Disease

Interventions

BIOLOGICAL

Octaplas™

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

BIOLOGICAL

Plasma

Plasma as prescribed by the treating physician.

Sponsors & Collaborators

  • Octapharma

    lead INDUSTRY

Principal Investigators

  • Wolfgang Frenzel · International Medical Monitor

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02037373 on ClinicalTrials.gov