Liver Machine Perfusion (MP) device for Transplantation, Liver

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cleveland Clinic, Cleveland, OH
Transplantation, Liver
Liver Machine Perfusion (MP) device - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of hypothermic and normothermic machine perfusion may help preserve livers for transplantation.

See full description

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Liver Machine Perfusion (MP) device will improve 2 primary outcomes and 10 secondary outcomes in patients with Transplantation, Liver. Measurement will happen over the course of up to 36 weeks.

1 month post-transplant
graft survival at 1 month post-transplant
patient survival at 1 month post-transplant
6 month post-transplant
graft survival at 6 month post-transplant
patient survival at 6 month post-transplant
during surgery
Estimated blood loss at transplant surgery
Day 7
peak alanine aminotransferases in the first 7 days after transplantation
peak aspartate aminotransferases in the first 7 days after transplantation
rate of post-transplant early allograft dysfunction (EAD)
on post-operative day 7
international normalized ratio on post-operative day 7
total bilirubin on post-operative day 7
up to 36 weeks
Hospital length of stay
up to 36weeks
ICU length of stay

Trial Safety

Trial Design

1 Treatment Group

Liver perfusion
1 of 1
Experimental Treatment

This trial requires 15 total participants across 1 different treatment group

This trial involves a single treatment. Liver Machine Perfusion (MP) Device is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Liver perfusion
Device
Device: Liver Machine Perfusion (MP) Device The liver grafts will be preserved at hypothermic and normothermic temperature on the institutional-developed Liver MP Device, and have continuous perfusion with oxygen supply in the ex vivo organ preservation phase.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 month post-transplant
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 month post-transplant for reporting.

Who is running the study

Principal Investigator
C. Q.
Cristiano Quintini, Director of Liver transplantation
The Cleveland Clinic

Closest Location

Cleveland Clinic - Cleveland, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients undergoing liver transplantation
Age 18 or older at the time of transplantation
Willingness and ability to comply with the study procedures
Signed Informed Consent Form

Patient Q&A Section

What are common treatments for transplantation, liver?

"Transplants, transplants of liver are the most common treatments for liver diseases. And also, it's an important issue that the immunosuppressives are often administated for transplants." - Anonymous Online Contributor

Unverified Answer

Can transplantation, liver be cured?

"Patients with end-stage liver disease with or without significant extrahepatic B cell disease could receive successful immunosuppressive treatment and potentially receive a potential cure by liver transplantation." - Anonymous Online Contributor

Unverified Answer

What are the signs of transplantation, liver?

"Patients who develop liver disease have an identifiable change in their health status in the weeks before presentation to the transplant unit. They have jaundice, vomiting or weakness. They have either increased fatigue or malaise and have a higher degree of jaundice with a bilirubin level of >50 µl/l. Patients who have developed graft-versus-host disease can be identified by symptoms including chills, chest pain, shortness of breath and an unfavourable chest X-ray. Patients may have had leukopenia when they are admitted to hospital. They also have a leukocytosis when they are presenting to the transplant unit. These are all signs of liver disease." - Anonymous Online Contributor

Unverified Answer

What is transplantation, liver?

"Liver transplants were first performed in Boston during the late 1940s. The liver is the largest and most complex organ in the human body and is transplanted in approximately 100,000 cases every year in the United States and Europe. Liver transplantation is a procedure that is usually carried out to help patients who lack a functioning organ or who have an organ that no longer performs its normal function. In most cases the recipient of a liver transplant will live an essentially normal life and go on to have happy, productive lives." - Anonymous Online Contributor

Unverified Answer

How many people get transplantation, liver a year in the United States?

"[More than one-third (34%), or about 600,000 people in the United States are transplanted each year for acute-on-chronic liver disease or cirrhosis, respectively.] It is estimated that the number of patients receiving donor liver transplants will reach an all-time high of approximately 2 million by 2050. About 90% of these are patients who previously were categorized as being on the continuum between the U.S. population and the population in countries where the world's liver transplant population is concentrated. In addition, the number of patients who might be eligible for living donor transplantation is far less than the number transplanted. Only a fraction of these chronically ill patients may be eligible for either transplantation or other alternative therapies." - Anonymous Online Contributor

Unverified Answer

What causes transplantation, liver?

"Liver cirrhosis has a complex multifactorial cause. Primary liver disease is a risk factor which is further affected by alcoholism and cirrhosis of other regions (i.e. portal hypertension, hyperactive liver disease and/or hepatic encephalopathy). Hepatitis viral or non-host viral infection can cause cirrhosis as well. Alcoholics and patients of HIV are at a higher risk. Non-specific and more specific factors include a family history of liver disease, viral load and HCV. Transplantation related factors include age of recipient, transplant type (i.e. deceased donor vs living donor, HLA mismatch." - Anonymous Online Contributor

Unverified Answer

What is the latest research for transplantation, liver?

"Recent advances in transplantation treatment may change these current guidelines. With the recent developments in transplants, we are approaching transplantation as a key component of a new multidisciplinary approach to transplant medicine. Continued clinical and translational research for transplant patients, with a focus on the prevention and treatment of acute rejection, as well as on improving kidney and liver function, will continue to evolve and lead to improvements in survival and quality of life, not only for the transplanted population but also for transplanted patients and their families." - Anonymous Online Contributor

Unverified Answer

Does transplantation, liver run in families?

"The fact that the families for whom LTx were considered are those who have a positive score indicates that this is a familial pattern of liver disease. The clinical presentation is also very similar to the familial presentation. The clinical and serological features in the first degree relatives have no significative different to the main patients and therefore are not sufficient to justify the exclusion of family screening. Findings from a recent study suggests that the prevalence of autoimmune liver disease in familial pattern in the general population is significant and must be studied before introducing LTx in this group." - Anonymous Online Contributor

Unverified Answer

What does liver machine perfusion (mp) device usually treat?

"Liver machine perfusion may provide safe, effective, and durable treatment for some liver diseases, such as, liver injuries, liver transplantation, and acute liver failure. As to hepatic tumor, liver machine perfusion treatment may be a helpful technique for patients with hepatic tumors." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in liver machine perfusion (mp) device for therapeutic use?

"Liver machine perfusion (mp) device, including the newest designs, has proven safety and efficacy in the treatment of many cirrhotic patients. Our machine perfusion device, which is made by a French device, has shown to increase the blood recovery of the liver to nearly normal levels in the group of transplanted patients. The treatment is simple, and requires minimal equipment. The machine perfusion technique in our hepatic machines was patented by Dr. M. Chatterjea; and the machines were registered in the Netherlands under a Belgian Law. We have now developed a new modular system for MP, which should increase the reliability of the blood and blood products recovery of the patient through a liver machine perfusion technique." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets transplantation, liver?

"By using Power-SEM site, we can find clinical trials that can help you find your optimal liver transplant. After doing some simple filtering criteria, you will find a great deal of good clinical trial to start with. It may be a good place for [inhibition therapy] for your patient." - Anonymous Online Contributor

Unverified Answer

How does liver machine perfusion (mp) device work?

"Our modified Liver Machine Perfusion (LMP) system had a good capacity for resuscitation and extended graft survival during warm ischemia. We hope that this may translate to good clinical results in patients undergoing elective orthotopic liver transplantation." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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