Recruiting

Observational Study

Sponsor:

Methodist Health System

Code:

NCT05944042

Conditions

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

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Observational Transplant Analysis

Study Details

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.

Conditions

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

Study ID

NCT05944042

Start date

Feb 1, 2023

Status verified date

Jan, 2024

Completion date

Feb 2, 2025

Anticipated

Primary completion date

Feb 2, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Observational Transplant Analysis

Identify more accurate predictive models of transplant risk

Primary outcome measure

  • Need for prospective registry studies to determine patient factors to measure long-term survivial [ Time Frame: 2 years ]
  • Methods of storing information on demographics of transplant patients [ Time Frame: 2 yrs ]

Central Contacts and Locations

Central contacts

Colette N Ndjom, MS

214-947-1280MHSIRB@mhd.com

Loretta W Bedell, MPH

214-947-4681mhsirb@mhd.com

Locations

Methodist Dallas Medical Center

Recruiting

Dallas, Texas, United States, 75203

Contacts

Colette N Ndjom, MS

214-947-4680mhsirb@mhd.com

Loretta W Bedell, MPH

217-947-4681mhsirb@mhd.com

Principal Investigator:

Alejandro Mejia, MD

More Information

Sponsor

Methodist Health System

Last update posted

Mar 27, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Methodist Health System on 2024-03-27.