Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2007-002 KKS
Study information
Scientific title
Acronym
Perfusionsstudie
Study hypothesis
Main question of the trial:
Does Ischaemic Type Biliary Lesions (ITBL) occur less frequently in a liver preserved by aortic perfusion plus ex situ arterial flushing than in a liver preserved by simple aortic perfusion?
Ethics approval
Received from the local ethics committee (Landesarztekammer Rheinland-Pfalz) on the 27th April 2007 (ref: 837.364.05 [5462]). The ethics committees of all other trial centres have to approve the study before the centres could start with their trial participation.
NOTE: In this study dealing with liver transplantation, only the Central Region of the German Foundation for Organ Transplantion (Region Mitte der Deutschen Stiftung Organtransplantation) is recruting. All other centres are "only" implanting the organs and making the follow-up.
Study design
Randomised, controlled, multicentre, parallel group, two-armed trial. The grafts will be delivered to the transplant centre in a blinded way.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Liver transplantation after preservation in brain-death organ donors
Intervention
Aortic in situ perfusion versus aortic in situ perfusion plus arterial back-table ex situ flushing.
At the beginning of the process of abdominal dissection, a tube is placed into the abdominal aorta (or into a common iliac artery). The perfusate (HTK [Histidine-Tryptophan-Ketoglutarate] solution) is connected to this tube. Usually a perfusion pressure of 100 to 150 cm water column is applied which is realised by elevation of the plastic bag containing the fluid. When the liver is dissected free in order to be retrieved the perfusion is started. At least 8000 ml of solution have to be used.
In the control group the approach of preservation is stopped at this point, the liver is retrieved, put into plastic bags containing preservation solution and is forwarded to the transplant centre of the respective patients to whom the graft was allocated by Eurotransplant.
In the case of additional ex-situ arterial perfusion, the liver is retrieved and placed into an ice water dish. There all branches of the hepatic artery are tied, a cannula is placed into the artery at is origin and the ex-situ perfusion is performed. For ex-situ perfusion, 300 ml of the perfusate at a pressure of 100 cm water column is used. After that procedure, the graft is forwarded in the identical way as for non-ex-situ perfused grafts.
The transplantation itself is going to be performed at the discretion of the respective centre. Follow-up will be six months.
Intervention type
Drug
Phase
Not Specified
Drug names
Histidine-Tryptophan-Ketoglutarate (HTK)
Primary outcome measures
Rate of ITBL six months after transplantation.
Secondary outcome measures
1. Rate of ITBL or death within six months after transplantation
2. Parenchymal function following transplantation
3. Documentation and analysis of adverse events
All secondary outcomes are measured within six months after transplantation.
Overall trial start date
09/07/2007
Overall trial end date
31/10/2009
Reason abandoned
Eligibility
Participant inclusion criteria
For the graft:
1. Liver graft retrieved in the Central Region of the German Foundation for Organ Transplantion (Region Mitte der Deutschen Stiftung Organtransplantation [DSO])
2. Donor 18 - 80 years
3. Graft allocation to a participating centre
For the recipient
1. Informed consent
2. Age 18 - 80 years
3. Standard criteria for liver transplantation (e.g. liver dysfunction because of cirrhosis, carcinoma)
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
126 - 174 depending on the result of the interim
Participant exclusion criteria
For the graft:
1. Liver cirrhosis
2. Liver intoxication
3. Liver dysfunction
4. Liver trauma
5. Graft not transplantable (decision according to Standard Operating Procedures [SOP])
6. Liver split
For the recipient:
1. Standard criteria for liver transplantation
Recruitment start date
09/07/2007
Recruitment end date
31/10/2009
Locations
Countries of recruitment
Germany
Trial participating centre
Director of Transplantation and Hepatobiliopancreatic Surgery
Mainz
55131
Germany
Sponsor information
Organisation
Johannes Gutenberg University of Mainz (Germany)
Sponsor details
University Mainz
Dekan des Fachbereiches Medizin
Obere Zahlbacher Str. 63
Mainz
55131
Germany
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Johannes Gutenberg University of Mainz (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary