Hepatic Transplantation Registry

Recruiting

• Conditions: Identify More Accurate Predictive Models of Transplant Risk to Monitor and Evaluate New and Existing Patient Factors
• Interventions: Other: Observational Transplant Analysis

• Registration Number: NCT05944042
• Lead Sponsor: Methodist Health System

Brief Summary

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.

Detailed 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

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-07-06
• Study First Submitted QC: 2023-07-06
• Study First Posted: 2023-07-13
• Status Verified: 2024-01
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27
• Primary Completion: 2025-02-02
• Study Completion: 2025-02-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intra-Operative Data:	Observational Transplant Analysis	Intra-Operative Data: Operative time, donor type, transfusions, intraoperative adverse events, mechanical ventilation, portal vein thrombosis, etc.
Post-Operative Data and Follow-Up:	Observational Transplant Analysis	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.

Primary Outcome Measures

Name	Time	Method
Need for prospective registry studies to determine patient factors to measure long-term survivial	2 years	As the demand for liver transplantation continues to grow, there is a need to identify more accurate predictive models of transplant risk. Therefore, prospective registry studies are needed to monitor and evaluate new and existing patient factors associated with long-term survival.
Methods of storing information on demographics of transplant patients	2 yrs	The objective is to provide a mechanism to store information regarding the demographic characteristics; pre-transplant, intra-transplant, and post-transplant laboratories; treatment strategies; complications; and outcomes in patients undergoing hepatic transplantation.

Secondary Outcome Measures

Name	Time	Method
Total Number and Description of Study Sites/Total Number of Subjects Projected	2 yrs	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 International classification of Disease (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.

Trial Locations

Locations (1)

Methodist Dallas Medical Center; 🇺🇸 Dallas, Texas, United States