Hepatic Transplantation Registry

Study Overview
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Brief Summary
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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
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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

Official Title
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Hepatic Transplantation Registry

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

Intervention / Treatment
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* Other: Observational Transplant Analysis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| demand for liver transplantation | 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-, intra-, 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 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 |