Health Condition 1: Z482- Encounter for aftercare followingorgan transplant
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Dr Avinash Ramani
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male, Female & Other gender patients aged 18 years and above 2. Patients who have undergone liver transplant surgery for the first time, from either a living or a cadaveric donor. 3.Patients / Legally Acceptable Representative who are willing to provide written informed consent. 4. Patients who are willing and able to comply with study procedures and follow-up assessments.
Exclusion criteria
Exclusion criteria: 1. Patients with history of prior Liver transplantation. 2. Patients with combined transplants of two organs. 3. Patients having transplant from a monozygotic/identical twin. 4. Patients with other clinical conditions and co-morbidities viz., malignancy, previous or active graft failure or active infection etc., which as per the investigator would jeopardize the outcome of the trial. 5. Patients currently participating in another clinical/investigational study. 6. Patients who, in the opinion of the investigator, are unlikely to comply with the study protocol or follow-up requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Diagnostic Test Measures like Sensitivity, specificity, Positive and Negative predictive values of the Trunome assay in detecting graft rejection as confirmed by biochemical assays and conventional tissue biopsy will be provided along with 95 percent confidence interval. ROC curves will be used to compare the diagnostic abilities of Trunome assay and conventional tissue biopsy.Timepoint: Visit 1- Baseline (Day 7), Visit 2- (Day 15), Visit 3- (Around Day 30), Visit 4- (Around Day 90) | — |
Secondary
| Measure | Time frame |
|---|---|
| ROC curves will be used to compare the diagnostic abilities of the cfDNA, ddcfDNA & T-Cell Apoptotic marker levels against Liver function test levels in patients with stable graft function Vs patients experiencing graft rejection. Spearmans correlation with biopsy, exclusively in patients undergoing biopsy, will be provided along with 95percent confidence interval.Timepoint: Visit 1- Baseline (Day 7), Visit 2- (Day 15), Visit 3- (Around Day 30), Visit 4- (Around Day 90) | — |
Countries
India
Contacts
Public ContactMr Bhavesh Trivedi
Acrannolife Genomics Private Limited
Outcome results
None listed