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

Liver Transplant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01172691
• Other study ID #: 010-085
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 28, 2010
• Last updated: March 13, 2015
• Start date: July 2010
• Est. completion date: November 2015

Study information

• Verified date: March 2015
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 70 Years

Eligibility

Inclusion Criteria:

• Liver Transplant

Exclusion Criteria:

• Living donor transplants

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Liver Transplant
• Reperfusion Injury

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
United States	Baylor Univsersity Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor Research Institute	Ikaria

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No