Liver Failure Clinical Trial
Official title:
Mobilization of Mesenchymal Stem Cells During Liver Transplantation
NCT number | NCT02557724 |
Other study ID # | 20140000266 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | July 2017 |
Verified date | October 2018 |
Source | Rutgers, The State University of New Jersey |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To study if the administration of corticoid hinder or enhance the mobilization of Mesenchymal Stem Cells (MSCs) in the peripheral blood during liver transplantation and whether this affects the outcome with respect to graft versus host response.
Status | Completed |
Enrollment | 35 |
Est. completion date | July 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - • Patients 21-80 capable of providing informed consent - ASA rating between 1-4 - Patients undergoing liver transplant or liver surgery for the first time. Exclusion Criteria: - • Patient less than 21 years of age - Patients unwilling to consent - If donor liver was obtained after cardiac death |
Country | Name | City | State |
---|---|---|---|
United States | University Hospital | Newark | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Rutgers, The State University of New Jersey |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | post operative liver injury | . Primary endpoint is defined by postoperative liver injury assessed by peak serum value of aspartate aminotransferase (AST) or alanine aminotransferase (ALT). | 0-7 post operative days | |
Secondary | Total Bilirubin level | bilirubin greater than or equal to 10mg/dl on day 7 | post operative day 7 | |
Secondary | (INR) International Normalized Ratio | INR> or = to 1.6 | post operative day 7 | |
Secondary | (ALT) Alanine Aminotransferase | ALT> 2000 IU/L | post operative day 7 | |
Secondary | (AST) Aspartate Aminotransferase | AST> 2000 IU/L | post operative day 7 |
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