Assessing Declined Liver Grafts With Normothermic Machine Perfusion to Reduce Transplant Waiting Time
NCT06874296
Digestive System Diseases, Liver Diseases
Hamburg, Free and Hanseatic City of Hamburg, Germany
View Trial DetailsNCT Number: NCT04551742
The social determinants of health have a large impact on health. For example, neighborhood socioeconomic deprivation is associated with increased risk of medication non-adherence, graft failure, and death in children after liver transplant. In order to address these socioeconomic inequities in outcomes, a more granular understanding of how the social determinants of health impact outcomes is needed. In this observational prospective cohort, caregivers of children undergoing liver transplantation will complete surveys and undergo in-depth, qualitative interviews. The survey will assess comprehensively for the social determinants of health (e.g. material economic hardship, health literacy, social connectedness, primary care quality, etc). The qualitative interviews will identify barriers and facilitators that socioeconomically deprived children/families have to obtaining the ideal outcome and identify health system opportunities to integrate social needs and medical care. Data will be linked to an existing prospective cohort study (The Society for Pediatric Liver Transplant registry) to assess the impact of social risk on outcomes after transplant.
Healthcare providers who take care of children undergoing liver transplant will also be included in the qualitative interviews. The goal of including this group in the study is to determine the health systems barriers and facilitators to social needs screening and intervention.
This study is active but is not currently recruiting participants.
Notify MeUp to 70 year
All sexes
Observational
Children's Hospital Los Angeles, Los Angeles, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Caregivers/parents of children with the following criteria will be approached for inclusion in this study:
Exclusion criteria
Caregivers/parents of children undergoing liver transplantation will be excluded it:
Inclusion criteria
for Interview Portion of the Study:
Time frame: 90 Days
Time frame: 1 Year
Time frame: 3 Years
The ideal outcome measure is a composite measure of morbidity after transplant defined as alive, ALT and GGT <50, normal GFR, no non-liver transplants, no cytopenias, and no PTLD.
Time frame: 90 Days
Time frame: 90 Days
Time frame: 3 Years
University of California, San Francisco
Other
Acronym: SOCIAL-TX
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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