Hypothermic Machine Preservation-Phase 2
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 10/14/2017 |
| Start Date: | December 2009 |
| End Date: | July 2014 |
Hypothermic Machine Preservation of Extended Criteria Liver Allografts for Transplantation
This is a study comparing a technique of continuous circulation to the liver as a means of
preventing liver damage during transportation to the transplant hospital. This new technique
of Machine Perfusion (MP) will be compared to the standard technique where the liver is
maintained in a bag of solution on ice without circulation. The investigators will evaluate
and compare the outcomes of the transplants with the new technique to the standard technique.
There will be 24 MP patient's in the study. The investigators have previously used this
technique with success in 20 human liver transplant patients. The investigators think there
will be a benefit in terms of less damage to and better function of the donor liver which
will result in faster recovery for the patients. This protective effect may allow us to
successfully transplant more patients and prevent people from dying while waiting for a liver
transplant.
preventing liver damage during transportation to the transplant hospital. This new technique
of Machine Perfusion (MP) will be compared to the standard technique where the liver is
maintained in a bag of solution on ice without circulation. The investigators will evaluate
and compare the outcomes of the transplants with the new technique to the standard technique.
There will be 24 MP patient's in the study. The investigators have previously used this
technique with success in 20 human liver transplant patients. The investigators think there
will be a benefit in terms of less damage to and better function of the donor liver which
will result in faster recovery for the patients. This protective effect may allow us to
successfully transplant more patients and prevent people from dying while waiting for a liver
transplant.
It is our hypothesis that liver machine perfusion will increase the safe utilization of the
existing supply of extended criteria donor(ECD) livers by (1) increasing the quality and
duration of preservation thereby reducing the clinical effects reperfusion injury (2)
improving early outcomes in patients receiving ECD liver allografts (3) developing reliable
markers for pretransplant assessment of the potential graft (4) giving surgeons more
confidence when transplanting ECD livers and (5) allowing an avenue for ex vivo manipulation
of the liver to protect or restore a transiently injured liver.
The proposed study is a matched cohort design. Potential subjects will be recruited from the
CLDT active Liver Transplant Waiting List. The Principal Investigator as well as the
CoInvestigators, are all actively involved in the pre transplant evaluation process. Patients
who are on the Waiting List and have provided written consent to receive an ECD graft will be
recruited for this trial. Subjects will be matched with 24 historical control patients who
received similar cold stored ECD grafts. Subjects will be matched on known covariates
including donor age, donation after cardiac death, steatosis, both warm and cold ischemia
times, recipient age, Model End-Stage Liver Disease (MELD) score and disease etiology.
Subjects will be noncritically ill, not in an intensive care unit, and have a MELD < 35 in
order to minimize the variability in outcome in the sickest patients. All subjects must
provide written informed consent and meet the inclusion and exclusion criteria.
Subjects will be followed for one year post transplantation, in conjunction with their
routine liver transplant followup appointments. Retention of subjects for this trial will not
be a challenge, in that the followup visit time points (postoperative days 1 through the
discharge date, 7, 14, 30, 90, 180 and 365) are all consistent with our standard of care.
existing supply of extended criteria donor(ECD) livers by (1) increasing the quality and
duration of preservation thereby reducing the clinical effects reperfusion injury (2)
improving early outcomes in patients receiving ECD liver allografts (3) developing reliable
markers for pretransplant assessment of the potential graft (4) giving surgeons more
confidence when transplanting ECD livers and (5) allowing an avenue for ex vivo manipulation
of the liver to protect or restore a transiently injured liver.
The proposed study is a matched cohort design. Potential subjects will be recruited from the
CLDT active Liver Transplant Waiting List. The Principal Investigator as well as the
CoInvestigators, are all actively involved in the pre transplant evaluation process. Patients
who are on the Waiting List and have provided written consent to receive an ECD graft will be
recruited for this trial. Subjects will be matched with 24 historical control patients who
received similar cold stored ECD grafts. Subjects will be matched on known covariates
including donor age, donation after cardiac death, steatosis, both warm and cold ischemia
times, recipient age, Model End-Stage Liver Disease (MELD) score and disease etiology.
Subjects will be noncritically ill, not in an intensive care unit, and have a MELD < 35 in
order to minimize the variability in outcome in the sickest patients. All subjects must
provide written informed consent and meet the inclusion and exclusion criteria.
Subjects will be followed for one year post transplantation, in conjunction with their
routine liver transplant followup appointments. Retention of subjects for this trial will not
be a challenge, in that the followup visit time points (postoperative days 1 through the
discharge date, 7, 14, 30, 90, 180 and 365) are all consistent with our standard of care.
Inclusion Criteria:
- Signed written informed IRB consent by patient or patient's legally appointed
representative.
- Be at least 18 years of age; male or female.
- Listed with UNOS for liver transplantation.
- Organ declined by at least one transplant center
- Extended criteria donor as defined by:
- Presence of hepatitis C antibody
- Donation after Cardiac Death (DCD)
- Severe Hypernatremia: donor serum sodium >165 meq/L for at least 12 hours prior
to procurement
- Donor age ≥65 years
- Presence of significant steatosis >25% macrovesicular by biopsy
- Evidence of significant donor ischemic injury
- Current donor serum AST or ALT >1000 IU/L
- Ischemic injury evidenced by prolonged hypotension, high pressor requirement
and/or rising serum liver function tests or one test more than five times the
upper limit of normal (AST, ALT, or Total Bilirubin)
Exclusion Criteria:
- Patients in whom the donor liver will be subjected to less than 4 hours of cold
ischemia (surgeon desires immediate implantation)
- Patient hospitalized in ICU at time of transplantation and/or physiologic MELD score
>35
- Dual organ recipient
- ABO incompatibility
- Retransplantation
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