Standard Issue Transfusion Versus Fresher Red Blood Cell Use in Intensive Care- A Randomised Controlled Trial

Study Overview
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Brief Summary
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In Australia, blood for transfusion has a use by date of 42 days after collection. The actual age of blood given to patients depends on what is available at the time and the rate of usage. During the last decade, it has been reported that blood transfusion in patients admitted to intensive care was associated with an independent increase of mortality. Some research suggests that transfusion of fresher blood might help patients in the intensive care unit to reach a better recovery. This project will test whether patients who receive 'fresher' blood do better than patients who receive 'standard issue' blood.

Detailed Description
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Inclusion criteria •Patients hospitalised in ICU with an anticipated ICU stay of at least 24 hours, in whom the decision has been made by medical staff to transfuse at least one RBC unit. Exclusion criteria Age younger than 18 Previous RBC transfusion during the current hospital admission (including transfusion in another hospital for transferred patients) Diagnosis of transplantation or hematologic diseases Pregnancy Cardiac surgery during the present hospital admission Expected to die imminently (<24hrs) The treating physician believes it is not in the best interest of the patient to be randomised in this trial. Known objection to the administration of human blood products Participation in a competing study Primary outcome- 90 day mortality Secondary outcomes 28 day mortality Persistent Organ Dysfunction combined with death at 28 Days alive and free of mechanical ventilation at day 90 post randomisation Day alive and free of renal replacement therapy at day 90 post randomisation Blood stream infection in ICU (post randomisation) defined using the Center for Disease Control and Prevention/National Healthcare Safety Network criteria Length of stay in ICU and in hospital post randomisation Febrile non-haemolytic transfusion reactions EQ-5D score at Day 90 post randomisation

Official Title
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A Multi-centre Randomised Double Blinded Phase III Trial of the Effect of Standard Issue Red Blood Cell Blood Units on Mortality Compared to Freshest Available Red Blood Cell Units

Conditions
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Transfusion, Age of Blood

Intervention / Treatment
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* Other: Blood transfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients hospitalised in ICU with an anticipated ICU stay of at least 24 hours, in whom the decision has been made by medical staff to transfuse at least one RBC unit. Exclusion Criteria: Age younger than 18 Previous RBC transfusion during the current hospital admission (including transfusion in another hospital for transferred patients) Diagnosis of transplantation or hematologic diseases Pregnancy Cardiac surgery during the present hospital admission Expected to die imminently (<24hrs) The treating physician believes it is not in the best interest of the patient to be randomised in this trial. Known objection to the administration of human blood products Participation in a competing study (see below)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care<br>Blood Transfusion Standard of care- oldest blood. | Other: Blood transfusion<br>* Blood transfusion in ICU patients aged 18 and over.<br>|
| Other: Arm B<br>Blood Transfusion Freshest blood. | Other: Blood transfusion<br>* Blood transfusion in ICU patients aged 18 and over.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality at Day 90 | Mortality at Day 90 | 90 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality at Day 28 | Mortality at day 28 | 28 day | 
| Persistent Organ Dysfunction Combined With Death Measured at Day 28 | Persistent Organ Dysfunction combined with death measured at day 28 | day 28 | 
| Days Alive and Free of Mechanical Ventilation | Days alive and free of mechanical ventilation | day 28 | 
| Day Alive and Free of Renal Replacement Therapy. | Day alive and free of renal replacement therapy. | day 28 | 
| Blood Stream Infection in ICU (Post Randomisation) | Blood stream infection in ICU (post randomisation) Time Frame is in Days | While in ICU-Median duration in ICU - short term storage group was 4.2 days (2.0 - 9.3), long term storage group was 4.2 days (1.9 - 9.4) | 
| Length of Stay in ICU and in Hospital Post Randomisation (Days) | Median duration in ICU - short term storage group was 4.2 (2.0 - 9.3), long term storage group was 4.2 (1.9 - 9.4) Median duration in Hospital - short term storage group was 14.5 (7.4 - 27.5), long term storage group was 14.7 (7.4 - 28.3) In Days | Median duration in ICU- short term storage group 4.2 Days (2.0 - 9.3), long term storage group 4.2 Days (1.9 - 9.4). Median duration in Hospital- short term storage group was 14.5 days (7.4 - 27.5), long term storage group was 14.7 days(7.4 - 28.3) | 
| Proportion of Patients Who Suffer at Least One Febrile Non-haemolytic Transfusion Reaction in ICU | Proportion of patients who suffer at least one febrile non-haemolytic transfusion reaction in ICU | While in ICU-Median duration in ICU - short term storage group was 4.2 days (2.0 - 9.3), long term storage group was 4.2 days (1.9 - 9.4) | 
| EuroQol-5Dimension 5 Level (EQ-5D-5L) Score at Day 180 Post Randomisation | EuroQol-5Dimension 5 level (EQ-5D-5L) score at day 180 post randomisation - not reported yet | Day 180 |