This trial is active, not recruiting.

Condition liver transplant
Treatment inhaled nitric oxide (ino)
Phase phase 2
Sponsor Baylor Research Institute
Collaborator Ikaria
Start date July 2010
End date November 2014
Trial size 2 participants
Trial identifier NCT01172691, 010-085


This study is being done to determine if patients receiving (iNO) will have increased liver function and less damage from IR than patients who do not receive (iNO).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
inhaled nitric oxide (ino)
iNO or placebo will be administered at 40 ppm during the procedure starting when the Warm Ischemia Time begins - liver from ice. Stop when patient transported to ICU

Primary Outcomes

Evaluate the role of iNO in early ischemia reperfusion injury in marginal liver grafts during human orthotopic liver or liver/kidney transplantation.
time frame: 24 hours to 1 month

Secondary Outcomes

iNO group will show accelerated restoration of liver allograft function following liver transplantation and this may translate to better clinical outcomes. Marginal grafts may function better in the treated group
time frame: 1 month to 1 year

Eligibility Criteria

Male or female participants from 17 years up to 70 years old.

Inclusion Criteria: - Liver Transplant Exclusion Criteria: - Living donor transplants

Additional Information

Official title Randomized, Blinded, Controlled Trial of Inhaled Nitric Oxide (iNO) on Ischemia / Reperfusion Injury During Orthotopic Liver Transplantation With Marginal Grafts.
Principal investigator Michael A Ramsay, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Baylor Research Institute.