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

Primary Purpose

Liver Transplant

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Inhaled Nitric Oxide (iNO)
Sponsored by
Baylor Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Transplant focused on measuring Liver transplant

Eligibility Criteria

17 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Liver Transplant

Exclusion Criteria:

  • Living donor transplants

Sites / Locations

  • Baylor Univsersity Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Placebo and Study

Arm Description

Outcomes

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

Full Information

First Posted
July 28, 2010
Last Updated
March 13, 2015
Sponsor
Baylor Research Institute
Collaborators
Mallinckrodt
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1. Study Identification

Unique Protocol Identification Number
NCT01172691
Brief Title
Trial of Inhaled Nitric Oxide (iNO) on Ischemia / Reperfusion Injury During Orthotopic Liver Transplantation With Marginal Grafts
Official Title
Randomized, Blinded, Controlled Trial of Inhaled Nitric Oxide (iNO) on Ischemia / Reperfusion Injury During Orthotopic Liver Transplantation With Marginal Grafts.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
November 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute
Collaborators
Mallinckrodt

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplant
Keywords
Liver transplant

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo and Study
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Inhaled Nitric Oxide (iNO)
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Liver Transplant Exclusion Criteria: Living donor transplants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A Ramsay, MD
Organizational Affiliation
Baylor Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor Univsersity Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States

12. IPD Sharing Statement

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

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