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Effectiveness of N-acetylcysteine on Preservation Solution During Liver Transplantation

NCT01866644 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2018-08-13

No results posted yet for this study

Summary

Evaluate the effectiveness of the administration produced antioxidant N-acetylcysteine (NAC), decreasing the incidence of primary graft dysfunction and primary failure. The degree of dysfunction will be monitored by the method of LIMON, metabonomics techniques and according to the latest published validation Liver Transplantation (16 943-949 2010), total billirrubina greater than 10 mg / dl, INR greater than 1.6 in the seventh postoperative day and alanine or aspartate aminotransferase greater than 2000 IU / L in the first seven days. Liver dysfunction is considered, the presence of a transaminase value\> 2000 IU / L 1-7 postoperative day or BT\> 10 mg / dl or INR\> 1.6, both only in the 7th postoperative day (Olthoff et al Liver Transplantation 16,943 -949 2010).

Conditions

  • Unspecified Complication of Liver Transplant

Interventions

DRUG

N-acetylcysteine

Bath transplanted liver with N-acetylcysteine

DRUG

Saline

Bath saline transplanted liver

Sponsors & Collaborators

  • Instituto de Investigacion Sanitaria La Fe

    lead OTHER

Principal Investigators

  • Rafael Lopez Andujar, PhD · Hospital Universitario La Fe

  • Concepcion Gómez i Gavara, MD · Hospital Universitario La Fe

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01866644 on ClinicalTrials.gov