Standard Issue Transfusion Versus Fresher Red Blood Cell Use in Intensive Care- A Randomised Controlled Trial
- Conditions
- TransfusionAge of Blood
- Interventions
- Other: Blood transfusion
- Registration Number
- NCT01638416
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4994
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm B Blood transfusion Blood Transfusion Freshest blood. Standard of care Blood transfusion Blood Transfusion Standard of care- oldest blood.
- Primary Outcome Measures
Name Time Method Mortality at Day 90 90 Day Mortality at Day 90
- Secondary Outcome Measures
Name Time Method Mortality at Day 28 28 day Mortality at day 28
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
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
Day Alive and Free of Renal Replacement Therapy. day 28 Day alive and free of renal replacement therapy.
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
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
Trial Locations
- Locations (59)
Knox Private Hospital
🇦🇺Melbourne, Australia
Monash Medical Centre
🇦🇺Melbourne, Australia
Northern Hospital
🇦🇺Melbourne, Australia
Royal Melbourne Hospital
🇦🇺Melbourne, Australia
Sunshine Hospital
🇦🇺Melbourne, Australia
Western Hospital
🇦🇺Melbourne, Australia
Calvary Mater Newcastle
🇦🇺Newcastle, Australia
John Hunter Hospital
🇦🇺Newcastle, Australia
Fiona Stanley Hospital
🇦🇺Perth, Australia
St John of God Murdoch Hospital
🇦🇺Perth, Australia
Blacktown Hospital
🇦🇺Sydney, Australia
Royal Perth Hospital
🇦🇺Perth, Australia
Nepean Hospital
🇦🇺Sydney, Australia
Prince of Wales Hospital
🇦🇺Sydney, Australia
Epworth Hospital
🇦🇺Richmond, Australia
Royal Prince Alfred Hospital
🇦🇺Sydney, Australia
St George Hospital
🇦🇺Sydney, Australia
Tamworth Hospital
🇦🇺Tamworth, Australia
Wollongong Hospital
🇦🇺Wollongong, Australia
St Vincent's University Hospital
🇮🇪Dublin, Ireland
Limerick Regional Hospital
🇮🇪Limerick, Ireland
Auckland City Hospital CVICU
🇳🇿Auckland, New Zealand
Auckland City Hospital DCCM
🇳🇿Auckland, New Zealand
Middlemore Hospital
🇳🇿Auckland, New Zealand
Christchurch Hospital
🇳🇿Christchurch, New Zealand
North Shore Hospital
🇳🇿Auckland, New Zealand
Dunedin Hospital
🇳🇿Dunedin, New Zealand
Waikato Hospital
🇳🇿Hamilton, New Zealand
Nelson Hospital
🇳🇿Nelson, New Zealand
King Abdulaziz Medical City
🇸🇦Riyadh, Saudi Arabia
Wellington Hospital
🇳🇿Wellington, New Zealand
Helsinki University Hospital
🇫🇮Helsinki, Finland
Tampere University Hospital
🇫🇮Tampere, Finland
Cork University Hospital
🇮🇪Cork, Ireland
Beaumont Hospital
🇮🇪Dublin, Ireland
St James's Hospital
🇮🇪Dublin, Ireland
Galway Regional Hospital
🇮🇪Galway, Ireland
St Vincent's Hospital
🇦🇺Sydney, Australia
Albury Hospital
🇦🇺Albury, Australia
Lyell McEwin Hospital
🇦🇺Adelaide, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, Australia
Queen Elizabeth Hospital
🇦🇺Adelaide, Australia
Bendigo Hospital
🇦🇺Bendigo, Australia
Logan Hospital
🇦🇺Brisbane, Australia
Mater Private Hospital
🇦🇺Brisbane, Australia
Mater Adult Hospital
🇦🇺Brisbane, Australia
Princess Alexandra Hospital
🇦🇺Brisbane, Australia
Calvary Health
🇦🇺Canberra, Australia
Canberra Hospital
🇦🇺Canberra, Australia
Dandenong Hospital
🇦🇺Dandenong, Australia
Geelong Hospital
🇦🇺Geelong, Australia
Royal Brisbane and Women's Hospital
🇦🇺Brisbane, Australia
Gold Coast Hospital
🇦🇺Gold Coast, Australia
Gosford Hospital
🇦🇺Gosford, Australia
Royal Hobart Hospital
🇦🇺Hobart, Australia
Austin Hospital
🇦🇺Heidelberg, Australia
Cabrini Hospital
🇦🇺Melbourne, Australia
Frankston Hospital
🇦🇺Melbourne, Australia