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

Phase 2

• Conditions: Liver Transplant
• Interventions: Procedure: Inhaled Nitric Oxide (iNO)

• Registration Number: NCT01172691
• Lead Sponsor: Baylor Research Institute

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-28
• Study First Submitted QC: 2010-07-29
• Study First Posted: 2010-07-30
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-13
• Last Update Posted: 2015-03-17
• Primary Completion: 2015-11
• Study Completion: 2015-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Liver Transplant

Exclusion Criteria

• Living donor transplants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo and Study	Inhaled Nitric Oxide (iNO)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Baylor Univsersity Medical Center; 🇺🇸 Dallas, Texas, United States