HEGPOL: Randomised, placebo controlled, multicenter, double-blind clinical trial to investigate hepatoprotective effects of glycine in the postoperative phase of liver transplantation
ISRCTN | ISRCTN69350312 |
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DOI | https://doi.org/10.1186/ISRCTN69350312 |
Secondary identifying numbers | 22 00 16 |
- Submission date
- 29/06/2004
- Registration date
- 01/10/2004
- Last edited
- 24/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Steffen P. Luntz
Scientific
Scientific
Coordination Centre for Clinical Trials (KKS)
University of Heidelberg
Im Neuenheimer Feld 221
Heidelberg
69120
Germany
Phone | +49 (0)6221 56 4507 |
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steffen.luntz@med.uni-heidelberg.de |
Study information
Study design | Multicentre randomised double blind placebo controlled parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study acronym | HEGPOL |
Study objectives | Added 24/08/09: Kupffer cell-dependent ischemia / reperfusion (I/R) injury after liver transplantation is still of high clinical relevance, as it is strongly associated with primary dysfunction and primary nonfunction of the graft. Glycine, a non-toxic, non-essential amino acid has been conclusively shown in various experiments to prevent both activation of Kupffer cells and reperfusion injury. Based on both experimental and preliminary clinical data this study protocol was designed to further evaluate the early effect of glycine after liver transplantation. As of 24/08/09 this record has been extensively updated. All updates can be found in the relavent field with the above update date. |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Liver transplantation (LTX) |
Intervention | Verum group receives intravenous 250 ml glycine-solution (4.4%), starting prior to reperfusion of liver transplant during surgery and once daily during the first week after LTX. Placebo group receives intravenously 250 ml Aqua ad injection. |
Intervention type | Procedure/Surgery |
Primary outcome measure | Added 24/08/09: 1. Peak levels of both aspartat-amino-transaminase (AST) and alanine-amino-transaminase (ALT) as surrogates for the progression of liver related injury 2. Graft and patient survival up to 2 years after transplantation |
Secondary outcome measures | Added 24/08/09: 1. Effect of glycine on liver injury based on liver biopsy immediately after re-arterialisation (according to pathological report) 2. Total blood flow in portal vein and common hepatic artery 1 hour after reperfusion 3. Graft injury based on both AST and ALT serum levels (area under the curve [AUC]) 4. Incidence of early graft failure based on peak of transaminases or clotting factor support 5. Early onset of graft dysfunction based on Quick's value 5. Serum bilirubin (AUC) 7. CyA-induced nephrotoxicity based on retention parameters during the first eight days after transplantation (AUC) |
Overall study start date | 01/04/2006 |
Completion date | 30/04/2011 |
Eligibility
Participant type(s) | Patient |
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Age group | Not Specified |
Sex | Not Specified |
Target number of participants | Added 24/08/09: 130 |
Key inclusion criteria | Liver transplant recipients |
Key exclusion criteria | Does not match inclusion criteria |
Date of first enrolment | 01/04/2006 |
Date of final enrolment | 30/04/2011 |
Locations
Countries of recruitment
- Germany
Study participating centre
Coordination Centre for Clinical Trials (KKS)
Heidelberg
69120
Germany
69120
Germany
Sponsor information
University of Heidelberg (Germany)
University/education
University/education
Peter Schemmer, MD
Department of Surgery
University of Heidelberg
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
Phone | +49 (0)6221 56 6110 |
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Peter.Schemmer@med.uni-heidelberg.de | |
https://ror.org/038t36y30 |
Funders
Funder type
University/education
University of Heidelberg (Germany) - Medical faculty
No information available
Novartis Pharma (Germany) - unrestricted grant
No information available
Results and Publications
Intention to publish date | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Protocol article | protocol | 17/08/2005 | Yes | No |