Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
UKSH-0506; 0506
Study information
Scientific title
A multicentre study on regenerative effects of low-dose erythropoetin in burn and scald injuries
Acronym
EPO in burns
Study hypothesis
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
University Medical Centre Schleswig-Holstein, 21/12/2006, ref: 06-177. An amendment was approved on 22/09/2008.
Study design
Randomised-controlled double-blind trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Erythropoietin
Primary outcome measures
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.
Secondary outcome measures
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
Overall trial start date
01/08/2008
Overall trial end date
30/09/2013
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant 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
Recruitment start date
01/08/2008
Recruitment end date
30/09/2013
Locations
Countries of recruitment
Germany
Trial participating centre
Clinic for Plastic Surgery and Hand Surgery
Munchen
81675
Germany
Sponsor information
Organisation
Munich Technical University (Technische Universitaet Munchen) (Germany)
Sponsor details
Dean of the Faculty of Medicine
University Hospital Rechts der Isar
Ismaninger Str. 22
Munchen
81675
Germany
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
German Federal Ministry of Education and Research (Bundesministerium Fur Bildung und Forschung [BMBF]) (Germany)
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
2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23782555