Prospective randomised multicentre trial investigating liver preservation with Histidine-Tryptophan-Ketoglutarate (HTK) by simple aortic perfusion in comparison to aortic perfusion plus ex situ arterial flushing
| ISRCTN | ISRCTN78500982 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78500982 |
| Secondary identifying numbers | 2007-002 KKS |
- Submission date
- 09/07/2007
- Registration date
- 10/08/2007
- Last edited
- 29/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Gerd Otto
Scientific
Scientific
Director of Transplantation and Hepatobiliopancreatic Surgery
University of Mainz
Langenbeckstr. 1
Mainz
55131
Germany
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Prospective randomised multicentre trial investigating liver preservation with Histidine-Tryptophan-Ketoglutarate (HTK) by simple aortic perfusion in comparison to aortic perfusion plus ex situ arterial flushing |
| Study acronym | Perfusionsstudie |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Histidine-Tryptophan-Ketoglutarate (HTK) |
| Primary outcome measure | 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 study start date | 09/07/2007 |
| Completion date | 31/10/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 126 - 174 depending on the result of the interim |
| Total final enrolment | 242 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 09/07/2007 |
| Date of final enrolment | 31/10/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Director of Transplantation and Hepatobiliopancreatic Surgery
Mainz
55131
Germany
55131
Germany
Sponsor information
Johannes Gutenberg University of Mainz (Germany)
University/education
University/education
University Mainz
Dekan des Fachbereiches Medizin
Obere Zahlbacher Str. 63
Mainz
55131
Germany
| Website | http://www.klinik.uni-mainz.de |
|---|---|
"ROR" |
https://ror.org/023b0x485 |
Funders
Funder type
University/education
Johannes Gutenberg University of Mainz (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 26/06/2017 | 29/10/2021 | Yes | No |
Editorial Notes
29/10/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
