Title
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
Phase
Phase 3Lead Sponsor
Monash UniversityStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Transfusion ...Intervention/Treatment
Blood transfusionStudy Participants
4994In 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.
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
Blood transfusion in ICU patients aged 18 and over.
Blood Transfusion Standard of care- oldest blood.
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)
| Event Type | Organ System | Event Term | Arm B (Short Term Storage) | Standard of Care (Long Term Storage) |
|---|
Mortality at Day 90
Persistent Organ Dysfunction combined with death measured at day 28
Days alive and free of mechanical ventilation
Day alive and free of renal replacement therapy.
Blood stream infection in ICU (post randomisation) Time Frame is in 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
Proportion of patients who suffer at least one febrile non-haemolytic transfusion reaction in ICU
Mortality at day 28
EuroQol-5Dimension 5 level (EQ-5D-5L) score at day 180 post randomisation - not reported yet
Outcome Measure Data Not Reported
