Regenerative effects of erythropoietin in burn and scald injuries

ISRCTN	ISRCTN95777824
DOI	https://doi.org/10.1186/ISRCTN95777824
Clinical Trials Information System (CTIS)	2006-002886-38
Protocol serial number	UKSH-0506; 0506
Sponsor	Munich Technical University (Technische Universitaet Munchen) (Germany)
Funder	German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)

Submission date: 19/01/2007
Registration date: 18/04/2007
Last edited: 18/02/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Hans-Günther Machens
Scientific

Clinic for Plastic Surgery and Hand Surgery
University Hospital Rechts der Isar
Technische Universitaet Munchen
Ismaninger Str, 22
Munchen
81675
Germany

Study information

Primary study design	Interventional
Study design	Randomised-controlled double-blind trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A multicentre study on regenerative effects of low-dose erythropoetin in burn and scald injuries
Study acronym	EPO in burns
Study objectives	Current hypothesis as of 22/01/2009: The study aim is to prove a cytoprotective and regenerative effect Erythropoietin in thermally injured patients in terms of reduced morbidity and mortality. Initial information at time of registration: The study aim is to prove a cyto-protective and regenerative effect of low-dose erythropoietin (LDE) in thermally injured patients in terms of reduced morbidity and mortality. Please note that as of 22/01/2009 this record has been extensively amended. All updates can be found in the relevant section under the above update date. At this time, the anticipated start and end dates have also been amended. The initial trial dates were as follows: Initial overall trial start date: 01/05/2007 Initial overall trial end date: 01/05/2010 Please also note that as of 22/01/2009 the sponsor has also changed. The initial sponsor at time of registration was: University Medical Centre Schleswig-Holstein (Germany) Campus Lübeck Ratzeburger Allee 160 Lübeck 23538 Germany Please note that as of 30/04/2013, the overall trial end date was changed from 01/02/2013 to 30/09/2013.
Ethics approval(s)	University Medical Centre Schleswig-Holstein, 21/12/2006, ref: 06-177. An amendment was approved on 22/09/2008.
Health condition(s) or problem(s) studied	Thermal injuries
Intervention	Current interventions as of 22/01/2009: Erythropoietin 150 IU/kg body weight/application every second day. Subcutaneous drug administration every other day will be performed over 3 weeks. Initial information at time of registration: Erythropoietin 200 IE/kg body weight per week. Subcutaneous drug administration every other day will be performed over 4 weeks after injury.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Erythropoietin
Primary outcome measure(s)	Current outcomes as of 22/01/2009: Time until complete re-epithelialisation of SGDS at a definite location on the lateral upper thigh. Initial information at time of registration: Time until complete re-epidermalisation of split skin donor sites at the right medial upper thigh.
Key secondary outcome measure(s)	Current outcomes as of 22/01/2009: 1. Time until complete wound healing of type 2a SDW 2. Time until complete wound healing of skin graft 3. Cellular and molecular regenerative effects in SGDS and type 2a SDW, endothelial progenitor cell (EPC) recruitment, EPO receptor upregulation, protein expression 4. Quality of scar formation in conservatively and operatively treated wound locations 5. Number of packed red cells units, which are transfused during the treatment interval 6. Laboratory parameters (differential blood cell count, iron storage, EPO) 7. Cardiopulmonary parameters 8. Quality of life 12 months after trauma 9. Mortality (within 21 days, hospital stay and 1 year) 10. Adverse events 11. Gender differences in monitored data Initial information at time of registration: 1. Number of packed red cells units, which are transfused during the treatment interval 2. Laboratory parameters (differential blood cell count, iron storage, erythropoietin [EPO]) 3. Cardiopulmonary and renal parameters 4. Time until complete wound healing of deep 2° thermal wounds is achieved 5. Scar formation in conservatively and operatively treated wound locations 6. Quality of life 12 months after hospital discharge 7. Mortality (within 28 days, hospital stay and 1 year) 8. Adverse effects
Completion date	30/09/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	150
Total final enrolment	116
Key inclusion criteria	Current criteria as of 22/01/2009: 1. 2° and 3° burn and scald thermal injuries, which require operations including split skin harvesting and grafting 2. Men and women, aged greater than 18 and less than or equal to 75 years 3. Secure contraception Initial information at time of registration: 1. Deep 2° and 3° burn and scald thermal injuries, which require operations including split skin harvesting and grafting 2. Aged greater than or equal to 18 years
Key exclusion criteria	Current exclusion criteria as of 30/04/2013: 1. Admission later than 24 hours after injury 2. Haematological disorders (anaemia, lymphoma, leukaemia, inborn coagulation diseases) 3. Pregnancy or breast-feeding 4. Estimated survival shorter than one week (Abbreviated Burn Severity Index [ABSI] greater than 12) in patient older than 40 years of age 5. Total burn surface area involved less than 60% in patients older than 40 years of age, in patients younger than 40 years of age no limitation of maximum burned body surface and no limitation of ABSI score will be considered 6. Body weight less than 50 kg or greater than 110 kg 7. Upper lateral thights of leg thermally injured 8. Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative there of directly involved in the conduct of the protocol 9. Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study 10. Treatment with any investigational product in the last 12 months before study entry 11. Treatment with any immunosuppressive therapy, cancer-related chemotherapy or radiation therapy in the past 12 months 12. History of hypersensitivity to the investigational products 13. Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol 14. Clinically relevant cardiovascular (s.p. cardiac infarction, coronary heart disease [CHD], thromboembolic disease, thromboembolic events shortly before admission), hepatic (Child B or C liver disease), endocrine (morbid obesity: body mass index [BMI] greater than 40) or systemic (cancer) disease (malignoma) 15. Epileptiform diseases 16. Phenylketonuria 17. Human immunodeficiency virus (HIV) disease, acquired immune-deficiency virus (AIDS) 18. Informed consent missing Previous exclusion criteria as of 22/01/2009: Subjects presenting with any of the following will not be included in the study: 1. Admission later than 24 hours after injury 2. Informed consent given later than 48 hours after trauma 3. Suicide attempt 4. Skin Graft Donor Site (SGDS) created later than 4 days after trauma 5. Begin of treatment with study drug less than 24 hours before creation of SGDS 6. Haematological disorders (anaemia, lymphoma, leukaemia, inborn coagulation diseases) 7. Pregnancy or breast-feeding 8. Estimated survival shorter than one week (Abbreviated Burn Severity Index [ABSI] greater than 12) 9. Total burn surface area involved less than 10% or greater than 50% 10. Body weight less than 50 kg or greater than 110 kg 11. Upper lateral thigh of leg thermally injured 12. Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol 13. Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study 14. Treatment with any investigational product in the last 12 months before study entry 15. Treatment with any immunosuppressive therapy, cancer-related chemotherapy or radiation therapy in the past 12 months 16. History of hypersensitivity to the investigational products 17. Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol 18. Clinically relevant cardiovascular (s.p. cardiac infarction, coronary heart disease [CHD], thromboembolic disease, thromboembolic events shortly before admission), hepatic (Child B or C liver disease), endocrine (morbid obesity: body mass index [BMI] greater than 40 kg/m^2) or systemic (cancer) disease (malignoma) 19. Epileptiform diseases 20. Phenylketonuria 21. Human immunodeficiency virus (HIV) disease, acquired immune-deficiency virus (AIDS) 22. Informed consent missing Initial information at time of registration: 1. Haematological disorders (e.g. leukaemia, inborn coagulation diseases) 2. Pregnancy or breast-feeding 3. Estimated survival shorter than one week (Abbreviated Burn Severity Index [ABSI] > 12) 4. Total burn surface area involved > 40 % 5. Upper lateral thigh of both legs thermally injured 6. Subject is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol 7. Subject unlikely to comply with protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study 8. Treatment with any investigational product in the last 12 months before study entry 9. Treatment with any anti-cancer chemotherapy in the past 12 months 10. History of hypersensitivity to investigational products or drugs with similar chemical structures 11. Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol 12. Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult (e.g. Marfans syndrome, Child B or C liver disease, Morbid obesity [Body Mass Index > 40]) 13. Informed consent missing
Date of first enrolment	01/08/2008
Date of final enrolment	30/09/2013

Locations

Countries of recruitment

Germany

Study participating centre

Clinic for Plastic Surgery and Hand Surgery

Munchen
81675
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?
Results article	results	31/10/2018	18/02/2021	Yes	No
Protocol article	protocol	03/05/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/02/2021: Publication reference, total final enrolment and EudraCT number added.