The goal of this observational study is to learn about cytomegalovirus disease epidemiology in pediatric and adult liver transplant recipients in China. The main questions it aims to answer are: * The incidence of Cytomegalovirus (CMV) Infections (including clinical significant CMV reactivations and CMV Diseases) among children and adults Liver transplantation patients in China * All-cause Mortality (Survival probability at 1 year) * Incidence of Allograft Rejection. Number of subjects with allograft rejection * Graft Loss. Incidence of graft loss (re-transplantation) * Late-onset CMV Disease. Incidence of late-onset CMV disease (occurring after 100 days post-randomization) as adjudicated by end point committee * Bacterial Infections. Incidence of bacterial opportunistic infections * Major Fungal Infections. Opportunistic fungal infections * Major Non-CMV Viral Infections. Incidence of non-CMV viral infections We will collect demographic data of participants. All recipients and donors underwent preoperative testing for CMV pp65 antigenemia, plasma CMV DNA, and serum CMV antibody. All the recipients were followed up in a liver transplant follow-up clinic twice weekly for a month after discharge from hospital. After that, patients were followed up weekly for 3 months, fortnightly for 6 months, and monthly for 12 months.
Study Type
OBSERVATIONAL
Enrollment
800
Shanghai General Hospital
Shanghai, China
Number of Participants With Clinically Significant CMV Reactivation or CMV Disease
Clinically significant CMV reactivation was defined as a positive CMV-DNA PCR or pp65 antigenemia test in the context of clinical symptoms attributable to CMV. CMV disease was defined as evidence of CMV infection with documented end-organ disease (e.g., CMV hepatitis, colitis, pneumonitis) according to established international guidelines.
Time frame: Within 12 months after liver transplantation
Number of Participants Who Completed the 12-Month Follow-up
Participants were considered to have completed the study if they were alive and did not experience CMV reactivation requiring study closure, and provided data through the 12-month post-transplant visit.
Time frame: Within 12 months after liver transplantation
All-Cause Mortality
The occurrence of death from any cause within 12 months post-transplantation. As this was an observational study, mortality was assessed as an efficacy outcome (to calculate survival probability) rather than a solicited adverse event. Deaths were identified through scheduled study follow-ups, review of medical records, and when necessary, verification with civil registries.
Time frame: Within 12 months after liver transplantation
Number of Participants Lost to Follow-up
Participants were considered lost to follow-up if they could not be contacted for scheduled study visits or assessments despite multiple attempts, and no outcome data could be obtained after their last contact.
Time frame: Within 12 months after liver transplantation
Participants Asked to Withdraw
During follow-up, participants refuse to keep this study within 12 months after liver transplantation
Time frame: Within 12 months after liver transplantation
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