A multi-center study on the regenerative effects of erythropoietin in burn and scalding injuries: study protocol for a randomized controlled trial.

Abstract

BACKGROUND:

Although it was initially assumed that erythropoietin (EPO) was a hormone that only affected erythropoiesis, it has now been proposed that EPO plays an additional key role in the regulation of acute and chronic tissue damage.

METHODS/DESIGN:

This is a large, prospective, randomized, double-blind, multi-center study, funded by the German Federal Ministry of Education and Research, and fully approved by the designated ethics committee. The trial, which is to investigate the effects of EPO in severely burned patients, is in its recruitment phase and is being carried out in 13 German burn care centers. A total of 150 patients are to be enrolled to receive study medication every other day for 21 days (EPO 150 IU/kg body weight or placebo). A follow-up of one year is planned. The primary endpoint of this study is the time until complete re-epithelialization of a defined skin graft donor site is reached. Furthermore, clinical parameters such as wound healing, scar formation (using the Vancouver scar scale), laboratory values, quality of life (SF-36), angiogenic effects, and gene- and protein-expression patterns are to be determined. The results will be carefully evaluated for gender differences.

DISCUSSION:

We are seeking new insights into the mechanisms of wound healing in thermally injured patients and more detailed information about the role EPO plays, specifically in these complex interactions. We additionally expect that the biomimetic effects of EPO will be useful in the treatment of acute thermal dermal injuries.

TRIAL REGISTRATION:

EudraCT Number: 2006-002886-38, Protocol Number: 0506, ISRCT Number: http://controlled-trials.com/ISRCTN95777824/ISRCTN95777824.

• Authors: Christina Irene Günter, Augustinus Bader, Ulf Dornseifer, Silvia Egert, Sebastian Dunda, Gerrit Grieb, Thomas Wolter, Norbert Pallua, Tobias von Wild, Frank Siemers, Peter Mailänder, Oliver Thamm, Carsten Ernert, Michael Steen, Reiner Sievers, Bert Reichert, Afshin Rahmanian-Schwarz, Hans Schaller, Bernd Hartmann, Max Otte, Victoria Kehl, Christian Ohmann, Wolfgang Jelkmann, Hans-Günther Machens
• Journal: Trials (Trials) Vol. 14 Pg. 124 (May 03 2013) ISSN: 1745-6215 [Electronic] England
• PMID: 23782555 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Recombinant Proteins
• epoetin beta
• Erythropoietin

Topics

• Adolescent
• Adult
• Aged
• Burns (drug therapy, pathology, surgery)
• Clinical Protocols
• Double-Blind Method
• Drug Administration Schedule
• Erythropoietin (administration & dosage, therapeutic use)
• Female
• Germany
• Humans
• Male
• Middle Aged
• Prospective Studies
• Re-Epithelialization (drug effects)
• Recombinant Proteins (administration & dosage, therapeutic use)
• Regeneration (drug effects)
• Research Design
• Severity of Illness Index
• Skin (drug effects, injuries, pathology)
• Skin Transplantation
• Time Factors
• Treatment Outcome
• Young Adult