Standard Issue Transfusion Versus Fresher Red Blood Cell Use in Intensive

Status Completed

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01638416
Study type	Interventional
Source	Australian and New Zealand Intensive Care Research Centre
Contact
Status	Completed
Phase	Phase 3
Start date	October 2012
Completion date	June 2017

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms