HEGPOL: Randomised, placebo controlled, multicenter, double-blind clinical trial to investigate hepatoprotective effects of glycine in the postoperative phase of liver transplantation

ISRCTN ISRCTN69350312
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

Coordination Centre for Clinical Trials (KKS)
University of Heidelberg
Im Neuenheimer Feld 221
Heidelberg
69120
Germany

Phone +49 (0)6221 56 4507
Email steffen.luntz@med.uni-heidelberg.de

Study information

Study designMulticentre randomised double blind placebo controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymHEGPOL
Study objectivesAdded 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) studiedLiver transplantation (LTX)
InterventionVerum 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 typeProcedure/Surgery
Primary outcome measureAdded 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 measuresAdded 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 date01/04/2006
Completion date30/04/2011

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsAdded 24/08/09: 130
Key inclusion criteriaLiver transplant recipients
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment01/04/2006
Date of final enrolment30/04/2011

Locations

Countries of recruitment

  • Germany

Study participating centre

Coordination Centre for Clinical Trials (KKS)
Heidelberg
69120
Germany

Sponsor information

University of Heidelberg (Germany)
University/education

Peter Schemmer, MD
Department of Surgery
University of Heidelberg
Im Neuenheimer Feld 110
Heidelberg
69120
Germany

Phone +49 (0)6221 56 6110
Email Peter.Schemmer@med.uni-heidelberg.de
ROR logo "ROR" 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
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 17/08/2005 Yes No