Contact information
Type
Scientific
Contact name
Prof Dimitris Georgopoulos
ORCID ID
Contact details
ICU
University Hospital of Heraklion
Heraklion
711 10
Greece
-
georgop@med.uoc.gr
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Recombinant human erythropoietin therapy in critically ill patients: a dose response study
Acronym
Study hypothesis
The aim of our study was to assess the efficacy of two dosing schedules of recombinant human erythropoietin (rHuEPO) in increasing haematocrit (Hct) and haemoglobin (Hb) and reducing the exposure to allogeneic red blood cells (RBC) transfusion in critically ill patients.
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Critically ill patients with anaemia
Intervention
Patients were randomly assigned to receive:
1. Intravenous (i.v.) iron saccharate alone (control group)
2. i.v. iron saccharate and subcutaneous recombinant human erythropoietin (rHuEPO) 40,000 units once per week (Group A)
3. i.v. iron saccharate and subcutaneous rHuEPO 40,000 units three times per week (Group B)
RHuEPO was given for a minimum of 2 weeks or until ICU discharge or death. The maximum duration of therapy was 3 weeks.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Recombinant human erythropoietin (rHuEPO)
Primary outcome measure
The primary outcome end-points were:
1. Differences in Hct and Hb between groups
2. Transfusion independence between study day 1 and 28
Secondary outcome measures
Additional data recorded included:
1. ICU length of stay
2. Cumulative mortality through day 28
3. Adverse effects, assessed daily
Overall study start date
01/11/2000
Overall study end date
31/12/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All patients admitted to the intensive care unit (ICU) in each of the 13 participating centres were evaluated for study eligibility. Inclusion criteria were:
1. Age at least 18 years
2. Hb less than 12 g/dl
3. No iron deficiency defined as transferrin saturation less than 10% and ferritin less than 50 ng/ml
4. Negative pregnancy test (for females in the reproductive age)
5. An expected ICU stay of at least 7 days
6. Provision of signed informed consent
The expected duration of the ICU stay was judged on clinical grounds and APACHE II score by the ICU team at admittance to the unit.
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
148
Total final enrolment
148
Participant exclusion criteria
1. Chronic renal failure requiring dialysis
2. New onset (less than 6 months) seizures
3. Life expectancy of less than 7 days
4. Previous use of rHuEPO (within 3 months)
5. Recent use of cytostatics or recent radiotherapy (within 1 month)
6. Participation in another research protocol
Recruitment start date
01/11/2000
Recruitment end date
31/12/2003
Locations
Countries of recruitment
Greece
Study participating centre
ICU, University Hospital of Heraklion
Heraklion
711 10
Greece
Sponsor information
Organisation
Janssen-Cilag (Greece)
Sponsor details
L. Hrinis 56
Athens
151 21
Greece
-
Ispirou@jacgr.jnj.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Janssen-Cilag (Greece)
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 05/10/2005 | 07/01/2021 | Yes | No |