Abstract / Description of output
Abstract
Objective
To determine the feasibility of a pivotal randomised clinical trial of intravenous (IV) iron and erythropoietin in adult survivors of critical illness with anaemia requiring treatment in the intensive care unit.
Design
An investigator-initiated, parallel group, placebo-controlled, randomised, feasibility trial.
Setting
A tertiary intensive care unit (ICU) in Perth, Western Australia.
Participants
Adults with anaemia (haemoglobin <100g/L), requiring ICU-level care for more than 48 hours and likely to be ready for ICU discharge within 24 hours.
Interventions
A single dose of IV ferric carboxymaltose and Epoetin alfa (active group), or an equal volume of 0.9% saline (placebo group).
Main outcome measures
Study feasibility was considered met if the pilot achieved a recruitment rate of ≥2 participants per site per month, ≥ 90% of participants received their allocated study treatment, and≥ 90% of participants were followed up for the proposed pivotal trial primary outcome - days alive and at home to Day 90 (DAH90).
Results
The 40-participant planned sample size included twenty in each group and were enrolled between 1/9/2021 and 2/3/2022. Participants spent a median of 3.4 days (interquartile range 2.8-5.1) in ICU prior to enrolment and had a mean baseline haemoglobin of 83.7g/L (standard deviation 6.7). The recruitment rate was 6.7 participants per month [95% confidence interval (CI) 4.8-9.0], DAH90 follow up was 100% (95% CI 91.2%-100%), and 39 (97.5%, 95% CI 86.8%-99.9%) participants received the allocated study intervention. No serious adverse events were reported.
Conclusion
The ITHRIVE pilot demonstrated feasibility based on predefined participant recruitment, study drug administration and follow up thresholds.
Objective
To determine the feasibility of a pivotal randomised clinical trial of intravenous (IV) iron and erythropoietin in adult survivors of critical illness with anaemia requiring treatment in the intensive care unit.
Design
An investigator-initiated, parallel group, placebo-controlled, randomised, feasibility trial.
Setting
A tertiary intensive care unit (ICU) in Perth, Western Australia.
Participants
Adults with anaemia (haemoglobin <100g/L), requiring ICU-level care for more than 48 hours and likely to be ready for ICU discharge within 24 hours.
Interventions
A single dose of IV ferric carboxymaltose and Epoetin alfa (active group), or an equal volume of 0.9% saline (placebo group).
Main outcome measures
Study feasibility was considered met if the pilot achieved a recruitment rate of ≥2 participants per site per month, ≥ 90% of participants received their allocated study treatment, and≥ 90% of participants were followed up for the proposed pivotal trial primary outcome - days alive and at home to Day 90 (DAH90).
Results
The 40-participant planned sample size included twenty in each group and were enrolled between 1/9/2021 and 2/3/2022. Participants spent a median of 3.4 days (interquartile range 2.8-5.1) in ICU prior to enrolment and had a mean baseline haemoglobin of 83.7g/L (standard deviation 6.7). The recruitment rate was 6.7 participants per month [95% confidence interval (CI) 4.8-9.0], DAH90 follow up was 100% (95% CI 91.2%-100%), and 39 (97.5%, 95% CI 86.8%-99.9%) participants received the allocated study intervention. No serious adverse events were reported.
Conclusion
The ITHRIVE pilot demonstrated feasibility based on predefined participant recruitment, study drug administration and follow up thresholds.
Original language | English |
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Number of pages | 6 |
Journal | Critical Care and Resuscitation |
Early online date | 14 Dec 2023 |
DOIs | |
Publication status | E-pub ahead of print - 14 Dec 2023 |
Keywords / Materials (for Non-textual outputs)
- Anaemia
- Intensive care unit
- Critical care