Hepatic Transplantation Registry

Sponsor

Methodist Health System (Other)

Overall Status

Recruiting

CT.gov ID

NCT05944042

Collaborator

(none)

300

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Identify More Accurate Predictive Models of Transplant Risk to Monitor and Evaluate New and Existing Patient Factors	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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Hepatic Transplantation Registry

Actual Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

demand for liver transplantation [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-, intra-, and post-transplant laboratories; treatment strategies; complications; and outcomes in patients undergoing hepatic transplantation.

Secondary Outcome Measures

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 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Methodist Dallas Medical Center	Dallas	Texas	United States	75203

Sponsors and Collaborators

Methodist Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Methodist Health System

ClinicalTrials.gov Identifier:

NCT05944042

Other Study ID Numbers:

002.HPB.2023.D

First Posted:

Jul 13, 2023

Last Update Posted:

Jul 13, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 13, 2023