Hepatic Transplantation Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Identify More Accurate Predictive Models of Transplant Risk to Monitor and Evaluate New and Existing Patient Factors
• Intervention / Treatment: Other: Observational Transplant Analysis

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Colette N Ndjom, MS; Phone Number: 74681 214-947-1280; Email: MHSIRB@mhd.com
• Study Contact Backup: Name: Loretta W Bedell, MPH; Phone Number: 74681 214-947-4681; Email: mhsirb@mhd.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Recruiting
      • Methodist Dallas Medical Center
      • Contact: Colette N Ndjom, MS; Phone Number: 71280 214-947-4680; Email: mhsirb@mhd.com
      • Contact: Loretta W Bedell, MPH; Phone Number: 74681 217-947-4681; Email: mhsirb@mhd.com
      • Principal Investigator: Alejandro Mejia, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Age ≥18 years Submitted to hepatic transplantation (Current Procedural Terminology® code 47135 Patients will be identified based on ICD-10 procedure codes which are only available post-discharge in the EMR.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intra-Operative Data: Intra-Operative Data: Operative time, donor type, transfusions, intraoperative adverse events, mechanical ventilation, portal vein thrombosis, etc.	Other: Observational Transplant Analysis; Identify more accurate predictive models of transplant risk; Other Names: Predictive models of transplant usage
Post-Operative Data and Follow-Up: 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.	Other: Observational Transplant Analysis; Identify more accurate predictive models of transplant risk; Other Names: Predictive models of transplant usage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for prospective registry studies to determine patient factors to measure long-term survivial	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.	2 years
Methods of storing information on demographics of transplant patients	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.	2 yrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number and Description of Study Sites/Total Number of Subjects Projected	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.	2 yrs

Collaborators and Investigators

• Sponsor: Methodist Health System

Publications and helpful links

General Publications

• Jadlowiec CC, Taner T. Liver transplantation: Current status and challenges. World J Gastroenterol. 2016 May 14;22(18):4438-45. doi: 10.3748/wjg.v22.i18.4438.
• Zimmerman MA, Ghobrial RM, Tong MJ, Hiatt JR, Cameron AM, Hong J, Busuttil RW. Recurrence of hepatocellular carcinoma following liver transplantation: a review of preoperative and postoperative prognostic indicators. Arch Surg. 2008 Feb;143(2):182-8; discussion 188. doi: 10.1001/archsurg.2007.39.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): February 2, 2025
• Study Completion (Estimated): February 2, 2025

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 002.HPB.2023.D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Sharing of results generated by the data analysis during the course of the project will be through presentation at national scientific meetings and/or publication in open access journals. All information obtained will be source de-identified and presented on a large scale and not traceable to any one particular individual.
• IPD Sharing Time Frame: 2 years
• IPD Sharing Access Criteria: Data can be access via the Methodist Health system Clinical Research Institute (Regulatory Department)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No