Uses of Immunosuppression Therapy in Patients With Liver Transplantation
Conventionally, the outcome of liver transplantation is usually reported in terms of graft and patient survival, medical and surgical complications, but lack of health-related quality of life (HRQOL) that might be associated with immunosuppression complications (e.g., diabetes, hypertension, dyslipidemia, obesity, metabolic syndrome, cardiovascular disease, renal dysfunction, osteoporosis, and de novo malignancy), disease recurrence, and rejections after transplantation.
Evidence of Liver Transplantation
|Study Design:||Observational Model: Cohort|
|Official Title:||Trends of Immunosuppression Therapy and Their Effectiveness in Patients With Liver Transplantation|
- incidence of graft and patient mortality, treatment-related complications [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]Patient will be followed from the date of liver transplantation to the occurence of outcome event for 5 years
- health-related quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]health-related quality of life will be measured by EQ-5D-5L and 15D
- quality-adjusted life expectancy (QALE), loss-of-QALE [ Time Frame: 5 years ] [ Designated as safety issue: No ]
QALE:quality-adjusted weight for each health status (measured by EQ-5D)will be multiplied by the survival time and then summed to calculate the number of QALE.
Loss-of QALE: the life time expectancy (survival function) for thes study cohort will be compared with Taiwan general population of subjects who are age- and gender-matched with study subjects.
Biospecimen Retention: None Retained
no biospecimens are to be retained
|Study Start Date:||April 2013|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
liver transplantation recipients
adult liver transplantation recipients (>=20 years at the date of surgery)
Specific aims are proposed to achieve in this study:
- To compare graft and patient survival rate, incidence of treatment-related adverse effects between different patterns of immunosuppression combination among patients received post-liver transplant care in Kaohsiung Chang Gung Memorial Hospital (KCGMH), Taiwan.
- To quantify the long-term health impacts of immunosuppressive regimens on quality-adjusted life expectancy (QALE), the loss-of-QALE relating to immunosuppression therapy, and types of transplantation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01834690
|Contact: Chien-Ning Hsu, PhD||(07)7317123 ext 6134|
|Kaohsiung Chang Gung Memorial Hospital||Recruiting|
|Kaohsiung, Taiwan, 833|
|Contact: Chien-Ning Hsu, PhD|
|Principal Investigator: Chien-Ning Hsu, PhD|
|Principal Investigator:||Chien-Ning Hsu, PhD||Kaohsiung Chang Gung Memorial Hospital|