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Completed

NCT Number: NCT01172691

Trial of Inhaled Nitric Oxide (iNO) on Ischemia / Reperfusion Injury During Orthotopic Liver Transplantation With Marginal Grafts

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).

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Key information

Conditions

Liver Transplant

Age range

17 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Baylor Univsersity Medical Center

Dallas, Texas, 75246, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Liver Transplant

Exclusion criteria

  • Living donor transplants

Treatment and study plan

Inhaled Nitric Oxide (iNO)

Drug

iNO 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

Placebo Arm (Nitrogen)

Drug

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

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Collaborators

  • Mallinckrodt

Registry information

Official study title

Randomized, Blinded, Controlled Trial of Inhaled Nitric Oxide (iNO) on Ischemia / Reperfusion Injury During Orthotopic Liver Transplantation With Marginal Grafts.

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jul 30, 2010
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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