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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01638416
Recruitment Status : Completed
First Posted : July 11, 2012
Results First Posted : October 22, 2020
Last Update Posted : October 22, 2020
Sponsor:
Collaborators:
Australian Red Cross
New Zealand Blood Service
Irish Blood Transfusion Service
Finnish Red Cross Blood Service
King Abdulaziz Medical City
University College Dublin
Information provided by (Responsible Party):
David James Cooper, Australian and New Zealand Intensive Care Research Centre

Study Description
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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.

Condition or disease Intervention/treatment Phase
Transfusion Age of Blood Other: Blood transfusion Phase 3

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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4994 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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).
Primary Purpose: Treatment
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 Start Date : October 2012
Actual Primary Completion Date : April 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard of care
Blood Transfusion Standard of care- oldest blood.
 Other: Blood transfusion
Blood transfusion in ICU patients aged 18 and over.
Arm B
Blood Transfusion Freshest blood.
 Other: Blood transfusion
Blood transfusion in ICU patients aged 18 and over.


Outcome Measures
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Primary Outcome Measures :
  1. Mortality at Day 90 [ Time Frame: 90 Day ]
    Mortality at Day 90


Secondary Outcome Measures :
  1. Mortality at Day 28 [ Time Frame: 28 day ]
    Mortality at day 28

  2. Persistent Organ Dysfunction Combined With Death Measured at Day 28 [ Time Frame: day 28 ]
    Persistent Organ Dysfunction combined with death measured at day 28

  3. Days Alive and Free of Mechanical Ventilation [ Time Frame: day 28 ]
    Days alive and free of mechanical ventilation

  4. Day Alive and Free of Renal Replacement Therapy. [ Time Frame: day 28 ]
    Day alive and free of renal replacement therapy.

  5. Blood Stream Infection in ICU (Post Randomisation) [ 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) ]
    Blood stream infection in ICU (post randomisation) Time Frame is in Days

  6. Length of Stay in ICU and in Hospital Post Randomisation (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) ]
    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

  7. 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) ]
    Proportion of patients who suffer at least one febrile non-haemolytic transfusion reaction in ICU

  8. EuroQol-5Dimension 5 Level (EQ-5D-5L) Score at Day 180 Post Randomisation [ Time Frame: Day 180 ]
    EuroQol-5Dimension 5 level (EQ-5D-5L) score at day 180 post randomisation - not reported yet


Eligibility Criteria
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Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01638416


Locations
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Sponsors and Collaborators
Australian and New Zealand Intensive Care Research Centre
Australian Red Cross
New Zealand Blood Service
Irish Blood Transfusion Service
Finnish Red Cross Blood Service
King Abdulaziz Medical City
University College Dublin
Investigators
Layout table for investigator information
Principal Investigator: D. James Cooper, A.O., M.D. Monash University/Alfred Hospital
  Study Documents (Full-Text)

Documents provided by David James Cooper, Australian and New Zealand Intensive Care Research Centre:
Study Protocol and Statistical Analysis Plan  [PDF] November 20, 2014
Informed Consent Form  [PDF] June 21, 2013

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: David James Cooper, Professor, Australian and New Zealand Intensive Care Research Centre
ClinicalTrials.gov Identifier: NCT01638416    
Other Study ID Numbers: ANZICRCDJC006
First Posted: July 11, 2012    Key Record Dates
Results First Posted: October 22, 2020
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided