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Vasodilator
Inhaled Nitric Oxide (iNO) for Liver Transplant
Phase 2
Waitlist Available
Led By Michael A Ramsay, MD
Research Sponsored by Baylor Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Liver Transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours to 1 month
Awards & highlights
Study 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).
Eligible Conditions
- Liver Transplant
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours to 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours to 1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Evaluate the role of iNO in early ischemia reperfusion injury in marginal liver grafts during human orthotopic liver or liver/kidney transplantation.
Secondary outcome measures
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
Side effects data
From 2014 Phase 2 trial • 124 Patients • NCT0095548722%
Sepsis
8%
Necrotizing enterocolitis
5%
Threshold ROP
5%
Symptomatic PDA
3%
Severe ICH
100%
80%
60%
40%
20%
0%
Study treatment Arm
Inhaled Nitric Oxide (iNO)
Placebo (Nitrogen)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Placebo and StudyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Inhaled Nitric Oxide (iNO)
2007
Completed Phase 2
~130
Find a Location
Who is running the clinical trial?
Baylor Research InstituteLead Sponsor
200 Previous Clinical Trials
203,224 Total Patients Enrolled
MallinckrodtIndustry Sponsor
201 Previous Clinical Trials
16,226 Total Patients Enrolled
Michael A Ramsay, MDPrincipal InvestigatorBaylor Health Care System
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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