ITHRIVE: Iron and erythropoietin use in anaemic patients in the intensive care

Phase 2

Recruiting

• Conditions: Anaemia; Critical Illness; Blood - Anaemia

• Registration Number: ACTRN12621000595819
• Lead Sponsor: Fiona Stanley Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-19
• Last Update Posted: 27 March 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

1.Adult patient who has required ICU-level care for more than 48 hours
2.The treating clinician has determined that ICU discharge is appropriate or is likely to be appropriate in the next 24 hours
3.Haemoglobin <100g/L on the most recent usual care measurement within the last 24 hours

Exclusion Criteria

1. Received IV iron therapy or ESA therapy in the last three months
2. Active cancer+
3. The treating clinician believes that trial participation is not in the best interests of the patient
4. The treating clinician believes death during this hospital admission is inevitable
5. Any history of adverse reaction to IV iron or ESA therapy, or therapies derived from mammalian cells
6. Blood products are contraindicated
7. Receiving antibiotic therapy with a planned total therapy duration >10 days^
8. Thromboembolism chemoprophylaxis is contraindicated
9. Resident in a nursing home or high-level chronic care facility
10. Pregnancy or breast feeding
11. Weight less than 50 kg
12. Porphyria
13. Previously enrolled in ITHRIVE

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the number of days alive and at home between randomisation and Day 90 (DAH90). Days spent in rehabilitation or a nursing home are counted as days in hospital. Death prior to discharge from index admission will count as zero DAH90. DAH90 is a validated measure that includes death, duration of hospital stay, need for ongoing rehabilitation and occurrence of hospital readmission[Day 90 post randomisation];The proportion of participants that receive their allocated study treatment is equal to or more than 90% of participants. This will be assessed by an audit of the study database. This is a primary outcome for the pilot phase only.[End of recruitment and follow up period (90 days post-randomisation) ];The proportion of participants lost to follow up is less than 10%.This will be assessed by an audit of the study database. [End of recruitment and follow up period (90 days post randomisation)]