Age of Blood, Transfusion
Conditions
Brief 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
Interventions
OTHERBlood transfusion
Blood transfusion in ICU patients aged 18 and over.
Sponsors
Australian Red Cross
New Zealand Blood Service
Irish Blood Transfusion Service
Finnish Red Cross Blood Service
King Abdulaziz Medical City
University College Dublin
Australian and New Zealand Intensive Care Research Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Two staff not involved in the direct care of each patient checked the red-cell units, and concealed the collection and expiry dates from clinical staff using a bag with opaque panels (Australia, Ireland and Saudi Arabia), or an obscuring sticker (NZ and Finland).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality at Day 90 | 90 Day | Mortality at Day 90 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Persistent Organ Dysfunction Combined With Death Measured at Day 28 | day 28 | Persistent Organ Dysfunction combined with death measured at day 28 |
| Days Alive and Free of Mechanical Ventilation | day 28 | Days alive and free of mechanical ventilation |
| Day Alive and Free of Renal Replacement Therapy. | day 28 | Day alive and free of renal replacement therapy. |
| Mortality at Day 28 | 28 day | Mortality at day 28 |
| Length of Stay in ICU and in Hospital Post Randomisation (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) | 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 | 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) | Proportion of patients who suffer at least one febrile non-haemolytic transfusion reaction in ICU |
| EuroQol-5Dimension 5 Level (EQ-5D-5L) Score at Day 180 Post Randomisation | Day 180 | EuroQol-5Dimension 5 level (EQ-5D-5L) score at day 180 post randomisation - not reported yet |
| Blood Stream Infection in ICU (Post Randomisation) | 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) | Blood stream infection in ICU (post randomisation) Time Frame is in Days |
Countries
Australia, Finland, Ireland, New Zealand, Saudi Arabia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm B (Short Term Storage) Blood Transfusion Freshest blood.
Blood transfusion: Blood transfusion in ICU patients aged 18 and over. | 2,457 |
| Standard of Care (Long Term Storage) Blood Transfusion Standard of care- oldest blood.
Blood transfusion: Blood transfusion in ICU patients aged 18 and over. | 2,462 |
| Total | 4,919 |
Baseline characteristics
| Characteristic | Total | Standard of Care (Long Term Storage) | Arm B (Short Term Storage) |
|---|---|---|---|
| ABO Blood group Group A | 1889 Participants | 961 Participants | 928 Participants |
| ABO Blood group Group AB | 185 Participants | 93 Participants | 92 Participants |
| ABO Blood group Group B | 613 Participants | 303 Participants | 310 Participants |
| ABO Blood group Group O | 2231 Participants | 1105 Participants | 1126 Participants |
| ABO Blood group Missing Data | 1 Participants | 0 Participants | 1 Participants |
| Age, Continuous | 62.0 years STANDARD_DEVIATION 17.1 | 61.4 years STANDARD_DEVIATION 17.3 | 62.5 years STANDARD_DEVIATION 16.8 |
| APACHE III | 72.9 units on a scale STANDARD_DEVIATION 29.4 | 73.2 units on a scale STANDARD_DEVIATION 29.6 | 72.6 units on a scale STANDARD_DEVIATION 29.2 |
| Haemoglobin at Admission to ICU | 102 g/liter STANDARD_DEVIATION 23.3 | 102 g/liter STANDARD_DEVIATION 23.6 | 102 g/liter STANDARD_DEVIATION 23.1 |
| Haemoglobin at randomisation | 77.3 g/liter STANDARD_DEVIATION 12.9 | 77.3 g/liter STANDARD_DEVIATION 13 | 77.4 g/liter STANDARD_DEVIATION 12.8 |
| Primary Diagnosis Cardiovascular Condition | 668 Participants | 342 Participants | 326 Participants |
| Primary Diagnosis Gastrointestinal Condition | 1065 Participants | 514 Participants | 551 Participants |
| Primary Diagnosis Metabolic Condition | 139 Participants | 71 Participants | 68 Participants |
| Primary Diagnosis Missing Condition | 11 Participants | 6 Participants | 5 Participants |
| Primary Diagnosis Musculoskeletal | 213 Participants | 110 Participants | 103 Participants |
| Primary Diagnosis Neurological Condition | 372 Participants | 195 Participants | 177 Participants |
| Primary Diagnosis Other Condition | 86 Participants | 35 Participants | 51 Participants |
| Primary Diagnosis Renal Condition | 219 Participants | 109 Participants | 110 Participants |
| Primary Diagnosis Respiratory Condition | 835 Participants | 422 Participants | 413 Participants |
| Primary Diagnosis Sepsis | 809 Participants | 396 Participants | 413 Participants |
| Primary Diagnosis Trauma | 502 Participants | 262 Participants | 240 Participants |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Sex: Female, Male Female | 2350 Participants | 1204 Participants | 1146 Participants |
| Sex: Female, Male Male | 2569 Participants | 1258 Participants | 1311 Participants |
| SOFA Score | 7 units on a scale | 7 units on a scale | 7 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 687 / 2,410 | 678 / 2,414 |
| other Total, other adverse events | 158 / 2,457 | 127 / 2,462 |
| serious Total, serious adverse events | 0 / 2,457 | 0 / 2,462 |
Outcome results
Primary
Mortality at Day 90
Mortality at Day 90
Time frame: 90 Day
Population: Pre specified Sub groups
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm B (Short Term Storage) | Mortality at Day 90 | All patients | 610 participants |
| Arm B (Short Term Storage) | Mortality at Day 90 | APACHE III risk of Death =or>21.5% | 457 participants |
| Arm B (Short Term Storage) | Mortality at Day 90 | Non-Group O | 346 participants |
| Arm B (Short Term Storage) | Mortality at Day 90 | Baseline SOFA score = or < 7 | 210 participants |
| Arm B (Short Term Storage) | Mortality at Day 90 | Group O | 264 participants |
| Arm B (Short Term Storage) | Mortality at Day 90 | Baseline SOFA score >7 | 400 participants |
| Arm B (Short Term Storage) | Mortality at Day 90 | APACHE III risk of Death <21.5% | 152 participants |
| Standard of Care (Long Term Storage) | Mortality at Day 90 | Baseline SOFA score >7 | 403 participants |
| Standard of Care (Long Term Storage) | Mortality at Day 90 | Group O | 259 participants |
| Standard of Care (Long Term Storage) | Mortality at Day 90 | Non-Group O | 335 participants |
| Standard of Care (Long Term Storage) | Mortality at Day 90 | APACHE III risk of Death <21.5% | 169 participants |
| Standard of Care (Long Term Storage) | Mortality at Day 90 | APACHE III risk of Death =or>21.5% | 425 participants |
| Standard of Care (Long Term Storage) | Mortality at Day 90 | Baseline SOFA score = or < 7 | 191 participants |
| Standard of Care (Long Term Storage) | Mortality at Day 90 | All patients | 594 participants |
Secondary
Blood Stream Infection in ICU (Post Randomisation)
Blood stream infection in ICU (post randomisation) Time Frame is in Days
Time frame: 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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm B (Short Term Storage) | Blood Stream Infection in ICU (Post Randomisation) | 123 Participants |
| Standard of Care (Long Term Storage) | Blood Stream Infection in ICU (Post Randomisation) | 88 Participants |
Secondary
Day Alive and Free of Renal Replacement Therapy.
Day alive and free of renal replacement therapy.
Time frame: day 28
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm B (Short Term Storage) | Day Alive and Free of Renal Replacement Therapy. | 28 days |
| Standard of Care (Long Term Storage) | Day Alive and Free of Renal Replacement Therapy. | 22 days |
Secondary
Days Alive and Free of Mechanical Ventilation
Days alive and free of mechanical ventilation
Time frame: day 28
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arm B (Short Term Storage) | Days Alive and Free of Mechanical Ventilation | 25 days |
| Standard of Care (Long Term Storage) | Days Alive and Free of Mechanical Ventilation | 25 days |
Secondary
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
Time frame: Day 180
Secondary
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
Time frame: 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)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Arm B (Short Term Storage) | Length of Stay in ICU and in Hospital Post Randomisation (Days) | Days in ICU | 4.2 Days |
| Arm B (Short Term Storage) | Length of Stay in ICU and in Hospital Post Randomisation (Days) | Days in Hospital | 14.5 Days |
| Standard of Care (Long Term Storage) | Length of Stay in ICU and in Hospital Post Randomisation (Days) | Days in ICU | 4.2 Days |
| Standard of Care (Long Term Storage) | Length of Stay in ICU and in Hospital Post Randomisation (Days) | Days in Hospital | 14.7 Days |
Secondary
Mortality at Day 28
Mortality at day 28
Time frame: 28 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm B (Short Term Storage) | Mortality at Day 28 | 476 Participants |
| Standard of Care (Long Term Storage) | Mortality at Day 28 | 463 Participants |
Secondary
Persistent Organ Dysfunction Combined With Death Measured at Day 28
Persistent Organ Dysfunction combined with death measured at day 28
Time frame: day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm B (Short Term Storage) | Persistent Organ Dysfunction Combined With Death Measured at Day 28 | 573 Participants |
| Standard of Care (Long Term Storage) | Persistent Organ Dysfunction Combined With Death Measured at Day 28 | 549 Participants |
Secondary
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
Time frame: 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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm B (Short Term Storage) | Proportion of Patients Who Suffer at Least One Febrile Non-haemolytic Transfusion Reaction in ICU | 35 Participants |
| Standard of Care (Long Term Storage) | Proportion of Patients Who Suffer at Least One Febrile Non-haemolytic Transfusion Reaction in ICU | 39 Participants |