NCT01638416

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,994 (actual)
• Sponsor: Australian and New Zealand Intensive Care Research Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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 1. 28 day mortality 2. Persistent Organ Dysfunction combined with death at 28 3. Days alive and free of mechanical ventilation at day 90 post randomisation 4. Day alive and free of renal replacement therapy at day 90 post randomisation 5. Blood stream infection in ICU (post randomisation) defined using the Center for Disease Control and Prevention/National Healthcare Safety Network criteria 6. Length of stay in ICU and in hospital post randomisation 7. Febrile non-haemolytic transfusion reactions 8. EQ-5D score at Day 90 post randomisation

Conditions

• Transfusion
• Age of Blood

Interventions

Type	Name	Description
OTHER	Blood transfusion	Blood transfusion in ICU patients aged 18 and over.

Timeline

• Start date: 2012-10-01
• Primary completion: 2017-04-01
• Completion: 2017-06-01
• First posted: 2012-07-11
• Last updated: 2020-10-22
• Results posted: 2020-10-22

Locations

60 sites across 5 countries: Australia, Finland, Ireland, New Zealand, Saudi Arabia