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
Protocol serial number	22 00 16
Sponsor	University of Heidelberg (Germany)
Funders	University of Heidelberg (Germany) - Medical faculty, Novartis Pharma (Germany) - unrestricted grant

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

Primary study design	Interventional
Study design	Multicentre randomised double blind placebo controlled parallel group trial
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	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)
Completion date	30/04/2011

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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