Liver Transplant Failure
Conditions
Brief summary
Determine the levels of Donor-derived (dd)cell-free DNA(cfDNA )in liver transplant recipients with normal liver function tests (LFTs) indicating stable immunosuppression status (IS). Based on this range use the dd-cfDNA levels to determine over or under IS in liver transplant patients to make changes to their IS medication regimen.
Detailed description
dd-cfDNA is a non-invasive method to measure graft function stability in liver transplant patients. Liver biopsy is the standard to determine liver rejection and graft function, but no tests exist currently to be able to help guide the IS regimen in these patients. LFTs are not as specific to determine graft function hence testing dd-cfDNA levels can help guide the Immunosuppression (IS )medications dosing and help identify rejection early.
Interventions
BEHAVIORALdonor-derived cell free DNA in liver
Determine the difference in age, gender, LFTs, IS regimen (tacrolimus/sirolimus/cyclosporin with mycophenolate mofetil (MMF) and /or prednisone) between patients who underwent liver transplant \<1 year PTX and \>1 year PTX
Sponsors
Methodist Health System
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age: ≥18 years 2. The patient underwent a liver transplant. 3. The patient at least has one level of dd-cfDNA documented
Exclusion criteria
* Patient not meeting the inclusion criteria will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| dd-cfDNA range in liver transplant patients | 1 year | Determine the dd-cfDNA in liver transplant patients with stable IS collected from July 2021 to July 2024 and compare the range between patients with \<1-year post-transplant (PTX) and \>1-year PTX by chart review using Methodist hospital data system. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Demographics: age (years), gender (male/female), race (Caucasian, Black, Hispanic, Asian, Other) | 1 year | Demographics differences in patients who underwent liver transplant less than 1 year of PTX and more than 1 year PTX |
| Days post-transplant at first dd-cfDNA | 1 year | Number of days post transplant at first dd-cfDNA |
| LFTs: Alanine transaminase(ALT), Aspartate transaminase(AST),Alkaline phosphatase( ALP), total bilirubin (Tbili) | 1 year | looking at the liver function tests in patients who underwent liver transplant less than 1 year of PTX and more than 1 year PTX |
| Serum Creatinine | 1 year | Measuring the serum creatinine levels |
Countries
United States
Contacts
Primary ContactKavya Vinod Mankulangara, PharmD
Backup ContactBethany Brauer, MPH
Outcome results
None listed