Global Utilization And Registry Database for Improved preservAtion of doNor Livers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-15

Study Completion Date

2028-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this registry is to collect and evaluate various clinical effectiveness parameters in patients with transplanted donor liver that were preserved and transported within the LIVERguard system, as well as retrospective standard of care patients

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Global Utilization And Registry Database for Improved preservAtion of doNor LUNGs

NCT04930289

Interstitial Lung Disease COPD Cystic Fibrosis +3 more

ENROLLING_BY_INVITATION

Hepatic Transplantation Registry

NCT05944042

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

RECRUITING

Molecular Assessment and Profiling of Liver Transplant Recipients

NCT04793360

Liver Transplantation Biomarkers

ACTIVE_NOT_RECRUITING

Liver Graft Viability Assessment During Normothermic Regional Perfusion

NCT05361044

Liver Transplant Failure

COMPLETED NA

Transplant Patient Registry of Liver, Kidney and/or Pancreas

NCT00238693

End Stage Renal Disease End Stage Liver Disease

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

GUARDIAN-Liver is a post-market, observational registry of adult and pediatric liver transplant recipient patients whose donor liver was preserved and transported within the LIVERguard. The data is being collected retrospectively from medical records of patients already transplanted before the initiation of the registry and any new patients who meet the eligibility criteria.

About 1000 male and female subjects meeting the study inclusion and exclusion criteria will be enrolled into the study at about 20 clinical sites.

Candidates that fit the eligibility criteria and have had their donor liver transported with a Paragonix product or a standard of care method can be enrolled. The baseline characteristics and outcomes of the two groups will be compared.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Diseases Liver Dysfunction Liver Transplant Disorder Liver Transplant Rejection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LIVERguard patient

Patients whose donor liver was transported with the LiverGuard device.

LIVERguard

Intervention Type DEVICE

The LIVERguard is an FDA cleared and is a CE-marked medical device intended to be used for the static hypothermic preservation of livers during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the liver. The intended organ storage time for the LIVERguard is up to 16 hours.

Standard Transport Patients

Patients whose donor liver was transported with a method other than the LiverGuard

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LIVERguard

The LIVERguard is an FDA cleared and is a CE-marked medical device intended to be used for the static hypothermic preservation of livers during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the liver. The intended organ storage time for the LIVERguard is up to 16 hours.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Donor and donor liver matched to the recipient based upon institutional medical practice
* Registered male or female primary liver transplant candidates