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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2015 by Baylor Research Institute.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01172691
First Posted: July 30, 2010
Last Update Posted: March 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Baylor Research Institute
July 28, 2010
July 30, 2010
March 17, 2015
July 2010
November 2015   (Final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT01172691 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Trial of Inhaled Nitric Oxide (iNO) on Ischemia / Reperfusion Injury During Orthotopic Liver Transplantation With Marginal Grafts
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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Liver Transplant
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
Experimental: Placebo and Study
Intervention: Procedure: Inhaled Nitric Oxide (iNO)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
2
November 2015
November 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Liver Transplant

Exclusion Criteria:

  • Living donor transplants
Sexes Eligible for Study: All
17 Years to 70 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01172691
010-085
No
Not Provided
Not Provided
Baylor Research Institute
Baylor Research Institute
Mallinckrodt
Principal Investigator: Michael A Ramsay, MD Baylor Health Care System
Baylor Research Institute
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP