Amniotic Tissue for Biliary Outcomes in Living Donor Liver Transplant
MiMedx AmnioFix
Prevention Study
Summary
Study start date: October 29, 2024
Actual date on which the first participant was enrolled.This study focuses on using placental tissue grafts in adult patients who receive a liver transplant from a living donor. The main aim is to see if these grafts, specifically the MiMedx placental tissue grafts, can safely reduce complications related to bile ducts, which are crucial for liver function. Bile duct problems are a common issue after liver transplants, and finding a way to reduce these could significantly improve patient outcomes. This is important because it can enhance the healing process and overall success of liver transplants. Participants in this study undergo a liver transplant at the Cleveland Clinic as per standard procedures. During the surgery, a MiMedx placental tissue graft is placed around the bile duct connection. After the transplant, doctors regularly check the patients for a year to see if any bile duct complications arise. The study involves reviewing the participants’ medical records during follow-up visits to track progress and outcomes. This helps researchers understand the effectiveness of the grafts in preventing complications.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: * Adults \>/= 18 years old * Recipient of LDLT Exclusion Criteria: * Patients who are deemed unsafe for participation for any reason by our multi-disciplinary liver transplant selection committee. * Patients \< 18 years old * Patients who cannot provide informed consent * Patients receiving deceased donor liver transplants, or who are not undergoing Liver transplant (LT) * Patients who do not wish to participate * Children, cognitively-impaired persons, pregnant women, students and house staff under the direct supervision of the investigator are considered vulnerable populations and will, therefore, be excluded from participation.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location