Condition category
Surgery
Date applied
29/06/2004
Date assigned
01/10/2004
Last edited
24/08/2009
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Steffen P. Luntz

ORCID ID

Contact details

Coordination Centre for Clinical Trials (KKS)
University of Heidelberg
Im Neuenheimer Feld 221
Heidelberg
69120
Germany
+49 (0)6221 56 4507
steffen.luntz@med.uni-heidelberg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

22 00 16

Study information

Scientific title

Acronym

HEGPOL

Study hypothesis

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

Not provided at time of registration

Study design

Multicentre randomised double blind placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/04/2006

Overall trial end date

30/04/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Liver transplant recipients

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Added 24/08/09: 130

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/04/2006

Recruitment end date

30/04/2011

Locations

Countries of recruitment

Germany

Trial participating centre

Coordination Centre for Clinical Trials (KKS)
Heidelberg
69120
Germany

Sponsor information

Organisation

University of Heidelberg (Germany)

Sponsor details

Peter Schemmer
MD
Department of Surgery
University of Heidelberg
Im Neuenheimer Feld 110
Heidelberg
69120
Germany
+49 (0)6221 56 6110
Peter.Schemmer@med.uni-heidelberg.de

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Heidelberg (Germany) - Medical faculty

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Novartis Pharma (Germany) - unrestricted grant

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

2005 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16105183

Publication citations

  1. Protocol

    Luntz SP, Unnebrink K, Seibert-Grafe M, Bunzendahl H, Kraus TW, Büchler MW, Klar E, Schemmer P, HEGPOL: randomized, placebo controlled, multicenter, double-blind clinical trial to investigate hepatoprotective effects of glycine in the postoperative phase of liver transplantation [ISRCTN69350312]., BMC Surg, 2005, 5, 18, doi: 10.1186/1471-2482-5-18.

Additional files

Editorial Notes