Identify More Accurate Predictive Models of Transplant Risk to Monitor and Evaluate New and Existing Patient FactorsNCT05944042
Hepatic Transplantation Registry
An observational study of Identify More Accurate Predictive Models of Transplant Risk to Monitor and Evaluate New and Existing Patient Factors, run by Methodist Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Identify More Accurate Predictive Models of Transplant Risk to Monitor and Evaluate New and Existing Patient Factors
- What is being tested?
- Observational Transplant Analysis
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 2 Feb 2025
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age ≥18 years Submitted to hepatic transplantation (Current Procedural Terminology® code 47135
Who cannot join
- Does not meet inclusion criteria specified in 3.1
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Methodist Dallas Medical Center
Dallas, Texas, 75203
Colette N Ndjom, MS, 214-947-4680 ext. 71280, mhsirb@mhd.com
Loretta W Bedell, MPH, 217-947-4681 ext. 74681, mhsirb@mhd.com
About this study
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.
Read the 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
- Being tested
- Observational Transplant Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Transplant AnalysisOther
Also called Predictive models of transplant usage
Identify more accurate predictive models of transplant risk
| Study group | Role | What they receive |
|---|---|---|
| Intra-Operative Data: | Intra-Operative Data: Operative time, donor type, transfusions, intraoperative adverse events, mechanical ventilation, portal vein thrombosis, etc. Receives: Other: Observational Transplant Analysis | |
| 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. Receives: Other: Observational Transplant Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 yrs
Secondary outcomes (1)
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.
Measured: 2 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 Feb 2023
- Primary completion2 Feb 2025 (estimated)
- Study completion2 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Identify More Accurate Predictive Models of Transplant Risk to Monitor and Evaluate New and Existing Patient FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944042
- Sponsor's protocol ID
- 002.HPB.2023.D
- Status last verified
- Jan 2024
- First submitted
- 6 Jul 2023
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 27182155Zimmerman 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.
PubMed 18283144
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Transplantation Registry
- ClinicalTrials.gov ID
- NCT05944042
- Acronym / sponsor ID
- 002.HPB.2023.D
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 2 Feb 2025 (estimated)
- Study completion
- 2 Feb 2025 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-Operative Data: | – | Other: Observational Transplant AnalysisIntra-Operative Data: Operative time, donor type, transfusions, intraoperative adverse events, mechanical ventilation, portal vein thrombosis, etc. |
| Post-Operative Data and Follow-Up: | – | Other: Observational Transplant AnalysisPost-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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Age ≥18 years Submitted to hepatic transplantation (Current Procedural Terminology® code 47135
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria specified in 3.1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational Transplant AnalysisAlso: Predictive models of transplant usageIdentify more accurate predictive models of transplant risk | Other | Intra-Operative Data:, Post-Operative Data and Follow-Up: |
Primary outcome
Need for prospective registry studies to determine patient factors to measure long-term survivial
Time frame: 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
Time frame: 2 yrs
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.
1 secondary outcome
Total Number and Description of Study Sites/Total Number of Subjects Projected
Time frame: 2 yrs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Background: PubMed 27182155Jadlowiec 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.
- Background: PubMed 18283144Zimmerman 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.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Identify More Accurate Predictive Models of Transplant Risk to Monitor and Evaluate New and Existing Patient Factors, run by Methodist Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Colette N Ndjom, MS (214-947-1280 ext. 74681, MHSIRB@mhd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for prospective registry studies to determine patient factors to measure long-term survivial (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05944042, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2024.