FindTrial
Sign In

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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01172691
Enrollment
23
Registered
2010-07-30
Start date
2010-07-01
Completion date
2014-01-22
Last updated
2026-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplant

Keywords

Liver transplant

Brief summary

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).

Interventions

DRUGInhaled Nitric Oxide (iNO)

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

DRUGPlacebo Arm (Nitrogen)

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

Sponsors

Baylor Research Institute
Lead SponsorOTHER
Mallinckrodt
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
17 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Liver Transplant

Exclusion criteria

* Living donor transplants

Design outcomes

Primary

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

Secondary

MeasureTime frame
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 group1 month to 1 year

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMichael A Ramsay, MD

Baylor Health Care System

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026