Hepatic Transplantation Registry

Methodist Health System

Status: Enrolling

Conditions: Identify More Accurate Predictive Models of Transplant Risk to Monitor and Evaluate New and Existing Patient Factors

Treatments: Other: Observational Transplant Analysis

Study type: Observational

Funder types: Other

Identifiers

NCT05944042

002.HPB.2023.D

Details and patient eligibility

About

The objective is to provide a mechanism to store information regarding the demographic characteristics; pre-, intra-, and post-transplant laboratories; treatment strategies; complications; and outcomes in patients undergoing hepatic transplantation.

Full description

This study will be conducted at Methodist Dallas Medical Center and include data from hepatic transplant patients beginning in January 2019 and continuing until statistical significance is achieved. Patients will be identified based on ICD-10 procedure codes which are only available post-discharge in the EMR. Data will be collected once patient is discharged and no additional procedures are necessary. All cases meeting the inclusion criteria are expected to be included in this study

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥18 years Submitted to hepatic transplantation (Current Procedural Terminology® code 47135

Exclusion criteria

• Does not meet inclusion criteria specified in 3.1

Trial design

300 participants in 2 patient groups

Intra-Operative Data:

Description:

Intra-Operative Data: Operative time, donor type, transfusions, intraoperative adverse events, mechanical ventilation, portal vein thrombosis, etc.

Treatment:

Other: Observational Transplant Analysis

Post-Operative Data and Follow-Up:

Description:

Post-Operative Data and Follow-Up: Post-operative laboratories (MELD score, ctDNA, etc.), adverse events, discharge status, hospital length of stay, readmissions, recurrence of primary disease, graft survival, renal disease, post-transplant metabolic syndrome and major cardiovascular events, etc.

Treatment:

Other: Observational Transplant Analysis