Recombinant human erythropoietin therapy in critically ill patients: a dose response study

Completed

• Conditions: Critically ill patients with anaemia; Haematological Disorders; Anaemia

• Registration Number: ISRCTN48523317
• Lead Sponsor: Janssen-Cilag (Greece)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06-16
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 148

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.

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome end-points were:<br>1. Differences in Hct and Hb between groups<br>2. Transfusion independence between study day 1 and 28

Secondary Outcome Measures

Name	Time	Method
Additional data recorded included: <br>1. ICU length of stay<br>2. Cumulative mortality through day 28<br>3. Adverse effects, assessed daily