Recombinant human erythropoietin therapy in critically ill patients: a dose response study
| ISRCTN | ISRCTN48523317 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48523317 |
| Secondary identifying numbers | N/A |
- Submission date
- 16/06/2005
- Registration date
- 16/06/2005
- Last edited
- 07/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Prof Dimitris Georgopoulos
Scientific
Scientific
ICU, University Hospital of Heraklion
Heraklion
711 10
Greece
| georgop@med.uoc.gr |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Recombinant human erythropoietin therapy in critically ill patients: a dose response study |
| 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 |
| 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 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 148 |
| Total final enrolment | 148 |
| 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 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
711 10
Greece
Sponsor information
Janssen-Cilag (Greece)
Industry
Industry
L. Hrinis 56
Athens
151 21
Greece
| Ispirou@jacgr.jnj.com |
Funders
Funder type
Industry
Janssen-Cilag (Greece)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 05/10/2005 | 07/01/2021 | Yes | No |
Editorial Notes
07/01/2021: Publication reference and total final enrolment added.
