NCT01172691

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

July 28, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2010

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2014

Completed
Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

3.6 years

First QC Date

July 28, 2010

Last Update Submit

January 27, 2026

Conditions

Liver Transplant

Keywords

Liver transplant

Outcome Measures

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.

    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

    1 month to 1 year

Study Arms (2)

Inhaled Nitric Oxid

EXPERIMENTAL

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

Drug: Inhaled Nitric Oxide (iNO)

Placebo Arm (nitrogen)

EXPERIMENTAL

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

Drug: Placebo Arm (Nitrogen)

Interventions

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

Placebo Arm (nitrogen)
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

Inhaled Nitric Oxid

Eligibility Criteria

Age17 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Liver Transplant

You may not qualify if:

  • Living donor transplants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor Univsersity Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Interventions

Nitrogen

Intervention Hierarchy (Ancestors)

ElementsInorganic ChemicalsGases

Study Officials

  • Michael A Ramsay, MD

    Baylor Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2010

First Posted

July 30, 2010

Study Start

July 1, 2010

Primary Completion

January 22, 2014

Study Completion

January 22, 2014

Last Updated

January 28, 2026

Record last verified: 2026-01

Locations

US(1)