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Phase 3 Completed N=4,994 Randomized Quadruple-blind Treatment

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

Transfusion · Age of Blood
Source: ClinicalTrials.gov NCT01638416 ↗
Enrolled (actual)
4,994
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Mortality at Day 90 — 610; 594; 264; 259 participants
◆ Published Evidence
Highly cited
190citations · ~21 / year
Age of Red Cells for Transfusion and Outcomes in Critically Ill Adults.
The New England journal of medicine · 2017 · Open access · Likely link

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.

Linked Publications (4)

  • Age of Red Cells for Transfusion and Outcomes in Critically Ill Adults.
    The New England journal of medicine · 2017 · 190 citations · Open access · Likely link
  • A randomised controlled trial of standard transfusion versus fresher red blood cell use in intensive care (TRANSFUSE): protocol and statistical analysis plan.
    Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine · 2014 · 25 citations · Open access · Likely link
  • The impact of prolonged storage of red blood cells on cancer survival.
    PloS one · 2013 · 20 citations · Open access · Likely link
  • Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support.
    The Cochrane database of systematic reviews · 2024 · 13 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Mortality at Day 90
610; 594; 264; 259; 346; 335
SECONDARY
Mortality at Day 28
476; 463
SECONDARY
Persistent Organ Dysfunction Combined With Death Measured at Day 28
573; 549
SECONDARY
Days Alive and Free of Mechanical Ventilation
25; 25
SECONDARY
Day Alive and Free of Renal Replacement Therapy.
28; 22
SECONDARY
Blood Stream Infection in ICU (Post Randomisation)
123; 88
SECONDARY
Length of Stay in ICU and in Hospital Post Randomisation (Days)
4.2; 4.2; 14.5; 14.7
SECONDARY
Proportion of Patients Who Suffer at Least One Febrile Non-haemolytic Transfusion Reaction in ICU
35; 39
SECONDARY
EuroQol-5Dimension 5 Level (EQ-5D-5L) Score at Day 180 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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01638416) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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