|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT01922323 |
|
Date of registration:
|
12/08/2013 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Metabolomics of Liver Regeneration Following Partial Hepatectomy in Healthy Living Liver Donors
|
|
Scientific title:
|
Metabolomics of Liver Regeneration Following Partial Hepatectomy in Healthy Living Liver Donors |
|
Date of first enrolment:
|
August 2013 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01922323 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Giuliano Testa, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Sammons Cancer Center, Baylor University Medical Center |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
1. Potential donor must be in excellent medical and psychological health.
2. Potential donor must be between the ages of 18 and 60.
3. Must have a compatible blood type to the recipient.
4. Must have health care coverage for non-donor related health issues that arise post
donation
5. Recipient and donor must have compatible body size.
6. Donors Body Mass Index (BMI) must be less than 30.
7. All previous donor abdominal surgeries will be reviewed on a case by case basis by the
surgeon.
Exclusion Criteria:
1. Positive blood test for Human Immunodeficiency Virus, Hepatitis C virus, Hepatitis B
virus
2. The size of the donor liver is not large enough to safely resection and still retain
enough volume to function normally after the surgery.
3. Liver biopsy show liver cirrhosis or early stages of HCC.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Liver Insufficiency
|
|
Primary Outcome(s)
|
|
Characterized Metabolic Changes during liver regeneration
[Time Frame: one year after donation]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|