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

Baylor Scott and White Health (BSWH)

Status and phase: Completed; Phase 2

Conditions: Liver Transplant

Treatments: Drug: Placebo Arm (Nitrogen); Drug: Inhaled Nitric Oxide (iNO)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01172691

010-085

Details and patient eligibility

About

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).

Enrollment: 23 patients

Sex: All

Ages: 17 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Liver Transplant

Exclusion criteria

• Living donor transplants

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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23 participants in 2 patient groups

Inhaled Nitric Oxid

Experimental group

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

Treatment:

Drug: Inhaled Nitric Oxide (iNO)

Placebo Arm (nitrogen)

Experimental group

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

Treatment:

Drug: Placebo Arm (Nitrogen)