Standard Issue Transfusion Versus Fresher Red Blood Cell Use in Intensive Care- A Randomised Controlled Trial

Transfusion Clinical Trial

— TRANSFUSE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01638416
• Other study ID #: ANZICRCDJC006
• Status: Completed
• Phase: Phase 3
• Start date: October 2012
• Est. completion date: June 2017

Study information

• Verified date: October 2020
• Source: Australian and New Zealand Intensive Care Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 4994
• Est. completion date: June 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Age of Blood
• Transfusion

Intervention

Other:
• Blood transfusion
Blood transfusion in ICU patients aged 18 and over.

Locations

Country	Name	City	State
Australia	Lyell McEwin Hospital	Adelaide
Australia	Queen Elizabeth Hospital	Adelaide
Australia	Royal Adelaide Hospital	Adelaide
Australia	Albury Hospital	Albury
Australia	Bendigo Hospital	Bendigo
Australia	Logan Hospital	Brisbane
Australia	Mater Adult Hospital	Brisbane
Australia	Mater Private Hospital	Brisbane
Australia	Princess Alexandra Hospital	Brisbane
Australia	Royal Brisbane and Women's Hospital	Brisbane
Australia	Calvary Health	Canberra
Australia	Canberra Hospital	Canberra
Australia	Dandenong Hospital	Dandenong
Australia	Geelong Hospital	Geelong
Australia	Gold Coast Hospital	Gold Coast
Australia	Gosford Hospital	Gosford
Australia	Austin Hospital	Heidelberg
Australia	Royal Hobart Hospital	Hobart
Australia	Cabrini Hospital	Melbourne
Australia	Frankston Hospital	Melbourne
Australia	Knox Private Hospital	Melbourne
Australia	Monash Medical Centre	Melbourne
Australia	Northern Hospital	Melbourne
Australia	Royal Melbourne Hospital	Melbourne
Australia	St Vincent's Hospital	Melbourne
Australia	Sunshine Hospital	Melbourne
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Western Hospital	Melbourne
Australia	Calvary Mater Newcastle	Newcastle
Australia	John Hunter Hospital	Newcastle
Australia	Fiona Stanley Hospital	Perth
Australia	Royal Perth Hospital	Perth
Australia	St John of God Murdoch Hospital	Perth
Australia	Epworth Hospital	Richmond
Australia	Blacktown Hospital	Sydney
Australia	Nepean Hospital	Sydney
Australia	Prince of Wales Hospital	Sydney
Australia	Royal Prince Alfred Hospital	Sydney
Australia	St George Hospital	Sydney
Australia	St Vincent's Hospital	Sydney
Australia	Tamworth Hospital	Tamworth
Australia	Wollongong Hospital	Wollongong
Finland	Helsinki University Hospital	Helsinki
Finland	Tampere University Hospital	Tampere
Ireland	Cork University Hospital	Cork
Ireland	Beaumont Hospital	Dublin
Ireland	St James's Hospital	Dublin
Ireland	St Vincent's University Hospital	Dublin
Ireland	Galway Regional Hospital	Galway
Ireland	Limerick Regional Hospital	Limerick
New Zealand	Auckland City Hospital CVICU	Auckland
New Zealand	Auckland City Hospital DCCM	Auckland
New Zealand	Middlemore Hospital	Auckland
New Zealand	North Shore Hospital	Auckland
New Zealand	Christchurch Hospital	Christchurch
New Zealand	Dunedin Hospital	Dunedin
New Zealand	Waikato Hospital	Hamilton
New Zealand	Nelson Hospital	Nelson
New Zealand	Wellington Hospital	Wellington
Saudi Arabia	King Abdulaziz Medical City	Riyadh

Sponsors (7)

Lead Sponsor	Collaborator
Australian and New Zealand Intensive Care Research Centre	Australian Red Cross, Finnish Red Cross, Irish Blood Transfusion Service, King Abdulaziz Medical City, New Zealand Blood Service, University College Dublin

Countries where clinical trial is conducted

Australia,  Finland,  Ireland,  New Zealand,  Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality at Day 90	Mortality at Day 90	90 Day
Secondary	Mortality at Day 28	Mortality at day 28	28 day
Secondary	Persistent Organ Dysfunction Combined With Death Measured at Day 28	Persistent Organ Dysfunction combined with death measured at day 28	day 28
Secondary	Days Alive and Free of Mechanical Ventilation	Days alive and free of mechanical ventilation	day 28
Secondary	Day Alive and Free of Renal Replacement Therapy.	Day alive and free of renal replacement therapy.	day 28
Secondary	Blood Stream Infection in ICU (Post Randomisation)	Blood stream infection in ICU (post randomisation) Time Frame is in Days	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)
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	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)
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	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)
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	Day 180

External Links

•   Australia and New Zealand Intensive Care Research Centre