Liver TransplantPhase 2NCT01172691
Trial of Inhaled Nitric Oxide (iNO) on Ischemia / Reperfusion Injury During Orthotopic Liver Transplantation With Marginal Grafts
A Phase 2 study testing Inhaled Nitric Oxide (iNO) in people with Liver Transplant, run by Baylor Research Institute at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 17 to 70 years
- Conditions the study is for
- Liver Transplant
- What is being tested?
- Inhaled Nitric Oxide (iNO)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to 22 Jan 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Liver Transplant
Who cannot join
- Living donor transplants
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Univsersity Medical Center
Dallas, Texas, 75246
About this study
Official title: Randomized, Blinded, Controlled 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).
- Conditions
- Liver Transplant
- Being tested
- Inhaled Nitric Oxide (iNO), Placebo Arm (Nitrogen)
- Keywords
- Liver transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo Arm (Nitrogen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the role of iNO in early ischemia reperfusion injury in marginal liver grafts during human orthotopic liver or liver/kidney transplantation.
Measured: 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
Measured: 1 month to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startJul 2010
- Primary completion22 Jan 2014
- Study completion22 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Sponsor
- Investigators
- Michael A Ramsay, MD, Principal investigator, Baylor Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172691
- Sponsor's protocol ID
- 010-085
- Status last verified
- Jan 2026
- First submitted
- 28 Jul 2010
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Blinded, Controlled Trial of Inhaled Nitric Oxide (iNO) on Ischemia / Reperfusion Injury During Orthotopic Liver Transplantation With Marginal Grafts.
- ClinicalTrials.gov ID
- NCT01172691
- Acronym / sponsor ID
- 010-085
- Conditions
- Liver Transplant
- Keywords
- Liver transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- Jul 2010 (actual)
- Primary completion
- 22 Jan 2014 (actual)
- Study completion
- 22 Jan 2014 (actual)
- First posted
- 30 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled Nitric Oxid | Experimental | Drug: 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 |
| Placebo Arm (nitrogen) | Experimental | Drug: Placebo Arm (Nitrogen)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 |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Liver Transplant
Key exclusion criteria (1 listed)
- Living donor transplants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled 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 | Drug | Inhaled Nitric Oxid |
| Placebo 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 | Drug | Placebo Arm (nitrogen) |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A Ramsay, MD principal investigator
Baylor Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inhaled Nitric Oxide (iNO) in people with Liver Transplant, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.