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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intra-Operative Data: | Intra-Operative Data: Operative time, donor type, transfusions, intraoperative adverse events, mechanical ventilation, portal vein thrombosis, etc. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational Transplant Analysis | Other | Identify more accurate predictive models of transplant risk |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Colette N Ndjom, MS | Contact | 214-947-1280 | 74681 | MHSIRB@mhd.com |
| Loretta W Bedell, MPH | Contact | 214-947-4681 | 74681 | mhsirb@mhd.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Methodist Dallas Medical Center | Recruiting | Dallas | Texas | 75203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27182155 | Background | 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. | |
| 18283144 | Background | 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. |
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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.
2 years
Data can be access via the Methodist Health system Clinical Research Institute (Regulatory Department)
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| 2 yrs |