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Study to Evaluate if Inhaled Nitric Oxide Improves Liver Function After Transplantation

NCT00582010 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-11-06

Study results available
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Summary

This blinded, placebo-controlled study will administer inhaled nitric oxide to patients undergoing liver transplantation. The purpose of the study is to test if inhaled nitric oxide prevents liver injury associated with the restoration of blood flow. The premise of the current study is provided by previous studies which document a protective effect of inhaled nitric oxide in this clinical setting.

Conditions

  • Reperfusion Injury
  • Liver Injury

Interventions

DRUG

inhaled nitric oxide

inhaled 80ppm for duration of surgery.

DRUG

nitrogen gas

inhaled

Sponsors & Collaborators

  • Mallinckrodt

    collaborator INDUSTRY

  • University of Washington

    collaborator OTHER

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Rakesh P Patel, PhD · University of Alabama at Birmingham

  • Keith A Jones, MD · University of Alabama at Birmingham

  • Devin E Eckhoff, MD · University of Alabama at Birmingham

  • John S Bynon, MD · University of Alabama at Birmingham

  • Blair Smith, MD · University of Alabama at Birmingham

  • Clark Cross, MD · University of Alabama at Birmingham

  • Luc Frenette, MD · University of Alabama at Birmingham

  • John D Lang, MD · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-03-31
Completion
2012-10-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00582010 on ClinicalTrials.gov