Clinical trial NCT01638416: Standard Issue Transfusion Versus Fresher Red Blood Cell Use in Intensive Care- A Randomised Controlled Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Transfusion
Age of Blood
Lead sponsor: Australian and New Zealand Intensive Care Research Centre
Sponsor class: OTHER
Collaborators: name: Australian Red Cross
name: New Zealand Blood Service
name: Irish Blood Transfusion Service
name: Finnish Red Cross Blood Service
name: King Abdulaziz Medical City
name: University College Dublin
First posted: 2012-07-11
Enrollment: 4994
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: Mortality at Day 90
timeFrame: 90 Day
Secondary outcomes:
measure: Mortality at Day 28
timeFrame: 28 day
measure: Persistent Organ Dysfunction Combined With Death Measured at Day 28
timeFrame: day 28
measure: Days Alive and Free of Mechanical Ventilation
timeFrame: day 28
measure: Day Alive and Free of Renal Replacement Therapy.
timeFrame: day 28
measure: Blood Stream Infection in ICU (Post Randomisation)
timeFrame: 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)
measure: Length of Stay in ICU and in Hospital Post Randomisation (Days)
timeFrame: 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)
measure: Proportion of Patients Who Suffer at Least One Febrile Non-haemolytic Transfusion Reaction in ICU
timeFrame: 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)
measure: EuroQol-5Dimension 5 Level (EQ-5D-5L) Score at Day 180 Post Randomisation
timeFrame: Day 180
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Adelaide
country: Australia
facility: Lyell McEwin Hospital
city: Adelaide
country: Australia
facility: Queen Elizabeth Hospital
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
city: Albury
country: Australia
facility: Albury Hospital
city: Bendigo
country: Australia
facility: Bendigo Hospital
city: Brisbane
country: Australia
facility: Logan Hospital
city: Brisbane
country: Australia
facility: Mater Adult Hospital
city: Brisbane
country: Australia
facility: Mater Private Hospital
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
city: Canberra
country: Australia
facility: Calvary Health
city: Canberra
country: Australia
facility: Canberra Hospital
city: Dandenong
country: Australia
facility: Dandenong Hospital
city: Geelong
country: Australia
facility: Geelong Hospital
city: Gold Coast
country: Australia
facility: Gold Coast Hospital
city: Gosford
country: Australia
facility: Gosford Hospital
city: Heidelberg
country: Australia
facility: Austin Hospital
city: Hobart
country: Australia
facility: Royal Hobart Hospital
city: Melbourne
country: Australia
facility: Cabrini Hospital
city: Melbourne
country: Australia
facility: Frankston Hospital
city: Melbourne
country: Australia
facility: Knox Private Hospital
city: Melbourne
country: Australia
facility: Monash Medical Centre
city: Melbourne
country: Australia
facility: Northern Hospital
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
city: Melbourne
country: Australia
facility: St Vincent's Hospital
city: Melbourne
country: Australia
facility: Sunshine Hospital
city: Melbourne
country: Australia
facility: Western Hospital
city: Newcastle
country: Australia
facility: Calvary Mater Newcastle
city: Newcastle
country: Australia
facility: John Hunter Hospital
city: Perth
country: Australia
facility: Fiona Stanley Hospital
city: Perth
country: Australia
facility: Royal Perth Hospital
city: Perth
country: Australia
facility: St John of God Murdoch Hospital
city: Richmond
country: Australia
facility: Epworth Hospital
city: Sydney
country: Australia
facility: Blacktown Hospital
city: Sydney
country: Australia
facility: Nepean Hospital
city: Sydney
country: Australia
facility: Prince of Wales Hospital
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
city: Sydney
country: Australia
facility: St George Hospital
city: Sydney
country: Australia
facility: St Vincent's Hospital
city: Tamworth
country: Australia
facility: Tamworth Hospital
city: Wollongong
country: Australia
facility: Wollongong Hospital
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Cork
country: Ireland
facility: Cork University Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Dublin
country: Ireland
facility: St James's Hospital
city: Dublin
country: Ireland
facility: St Vincent's University Hospital
city: Galway
country: Ireland
facility: Galway Regional Hospital
city: Limerick
country: Ireland
facility: Limerick Regional Hospital
city: Auckland
country: New Zealand
facility: Auckland City Hospital CVICU
city: Auckland
country: New Zealand
facility: Auckland City Hospital DCCM
city: Auckland
country: New Zealand
facility: Middlemore Hospital
city: Auckland
country: New Zealand
facility: North Shore Hospital
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Dunedin
country: New Zealand
facility: Dunedin Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Nelson
country: New Zealand
facility: Nelson Hospital
city: Wellington
country: New Zealand
facility: Wellington Hospital
city: Riyadh
country: Saudi Arabia
facility: King Abdulaziz Medical City
Study officials:
affiliation: Monash University/Alfred Hospital
name: D. James Cooper, A.O., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cooper DJ, McQuilten ZK, Nichol A, Ady B, Aubron C, Bailey M, Bellomo R, Gantner D, Irving DO, Kaukonen KM, McArthur C, Murray L, Pettila V, French C; TRANSFUSE Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group. Age of Red Cells for Transfusion and Outcomes in Critically Ill Adults. N Engl J Med. 2017 Nov 9;377(19):1858-1867. doi: 10.1056/NEJMoa1707572. Epub 2017 Sep 27.
citation: Kaukonen KM, Bailey M, Ady B, Aubron C, French C, Gantner D, Irving D, Murray L, Nichol A, Pettila V, McQuilten Z, Cooper DJ. A randomised controlled trial of standard transfusion versus fresher red blood cell use in intensive care (TRANSFUSE): protocol and statistical analysis plan. Crit Care Resusc. 2014 Dec;16(4):255-61.
citation: Kekre N, Mallick R, Allan D, Tinmouth A, Tay J. The impact of prolonged storage of red blood cells on cancer survival. PLoS One. 2013 Jul 16;8(7):e68820. doi: 10.1371/journal.pone.0068820. Print 2013.