Condition category
Haematological Disorders
Date applied
16/06/2005
Date assigned
16/06/2005
Last edited
02/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Dimitris Georgopoulos

ORCID ID

Contact details

ICU
University Hospital of Heraklion
Heraklion
711 10
Greece
georgop@med.uoc.gr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

Recombinant human erythropoietin (rHuEPO)

Primary outcome measures

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 trial start date

01/11/2000

Overall trial end date

31/12/2003

Reason abandoned

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

Patient

Age group

Adult

Gender

Both

Target number of participants

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

Trial 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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes