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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN69350312
Enrollment
130
Registered
2004-10-01
Start date
2006-04-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver transplantation (LTX) Surgery Transplanted organ and tissue status

Interventions

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

Sponsors

University of Heidelberg (Germany)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Liver transplant recipients

Exclusion criteria

Exclusion criteria: Does not match inclusion criteria

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026