Phase 3
N=4,994
Standard Issue Transfusion Versus Fresher Red Blood Cell Use in Intensive Care- A Randomised Controlled Trial
Transfusion · Age of Blood
Bottom Line
View on ClinicalTrials.gov: NCT01638416 ↗Enrolled (actual)
4,994
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Mortality at Day 90 — 610; 594; 264; 259 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Blood transfusion (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Australian and New Zealand Intensive Care Research Centre
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mortality at Day 90 |
610; 594; 264; 259; 346; 335 | — |
| SECONDARY Mortality at Day 28 |
476; 463 | — |
| SECONDARY Persistent Organ Dysfunction Combined With Death Measured at Day 28 |
573; 549 | — |
| SECONDARY Days Alive and Free of Mechanical Ventilation |
25; 25 | — |
| SECONDARY Day Alive and Free of Renal Replacement Therapy. |
28; 22 | — |
| SECONDARY Blood Stream Infection in ICU (Post Randomisation) |
123; 88 | — |
| SECONDARY Length of Stay in ICU and in Hospital Post Randomisation (Days) |
4.2; 4.2; 14.5; 14.7 | — |
| SECONDARY Proportion of Patients Who Suffer at Least One Febrile Non-haemolytic Transfusion Reaction in ICU |
35; 39 | — |
| SECONDARY EuroQol-5Dimension 5 Level (EQ-5D-5L) Score at Day 180 Post Randomisation |
— | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01638416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.