TRANSFUSE Study

(STandaRd Issue TrANsfusion versuS Fresher red blood cell Use in intenSive carE (TRANSFUSE) – a randomised controlled trial)

TRANSFUSE-RCT is a multi-centre, randomised, controlled trial, testing the effect of the freshest available red blood cell (RBC) unit compared to standard practice, on mortality in critically ill patients who require RBC transfusion.

RBC transfusion is a very common and potentially life-saving treatment in intensive care units (ICUs). However, RBC transfusion has also been associated with an increased risk of morbidity and/or mortality in critically ill patients. Although this association may reflect a variety of factors, attention has increasingly focused on the possible adverse impact of transfusing RBCs stored for a prolonged time, and have developed a so called "storage lesion". The term "storage lesion" refers to the fact that during the 42-days storage, in a way that increases over time, red cells develop important biochemical and structural derangements. These age-related changes in transfused RBCs may have important clinical consequences.

The hypothesis is that in critically ill patients who require a RBC transfusion, compared to standard practice, administration of the freshest available compatible RBC decreases 90-day patient mortality. Patients will be randomised to either the "Freshest available blood group" or the "Standard care group". Freshest available blood group: These patients will receive the freshest available group-specific compatible RBC unit in the transfusion service. Standard care group: These patients will receive standard practice, which is the oldest available group-specific compatible RBC unit in the transfusion service.

To guide blood transfusion policy rationally and nationally, we will test freshest available RBC versus standard practice (older blood) in critically ill patients in a definitive large multicenter RCT, using the established network of contributing hospitals.

This will be a collaboration between Intensive Care Units (ICUs) in the Irish Critical Care -Clinical Trials Group (ICC-CTG) and the Australian and New Zealand Intensive-Care Society- Clinical Trials Group (ANZICS-CTG) to determine whether, compared to standard care, transfusion of the freshest available allogenic red blood cells (RBC) decreases patient mortality.

This study is supported by the Irish Blood Transfusion Service and the Australia Blood services and will be overseen by collaboration between the ICC-CRC and the Australian and New Zealand Intensive Care- Research Centre

FAQ

What is a storage lesion?

Storage of RBCs in a preservative medium is associated with metabolic, biochemical and molecular changes to erythrocytes referred to as “the storage lesion”. These age-related changes in transfused RBC may have important clinical consequences.

How does it work?

Eligible patients who require a blood transfusion will be randomised by the ICU team using a web based system. The study number generated at randomisation will be conveyed to the transfusion service by telephone and on the blood request slip. The hospital transfusion service will allocate the appropriate blood to the patient as designated by a randomisation schedule. Allocation will be either standard practice (the oldest compatible available blood, front of fridge) or freshest compatible available (back of fridge). The patient will continue to receive the randomised treatment arm for any additional blood transfusion episodes during their hospital stay. A telephone follow-up will be conducted at 90 and 180days.

Inclusion Criteria

ICU patients or emergency department patients accepted for ICU admission, 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
 year
  • Previous RBC transfusion during the current hospital admission (including transfusion in another hospital for transferred patients)

  • Diagnosis of transplantation or hematologic malignancy

  • 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.