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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Australian and New Zealand Intensive Care Research Centre
Sponsor:
Collaborator:
Australian Red Cross Blood Service
Information provided by (Responsible Party):
David James Cooper, Australian and New Zealand Intensive Care Research Centre
ClinicalTrials.gov Identifier:
NCT01638416
First received: July 9, 2012
Last updated: July 18, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Transfusion, Age of Blood.
Other: Blood transfusion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
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

Resource links provided by NLM:


Further study details as provided by Australian and New Zealand Intensive Care Research Centre:

Primary Outcome Measures:
  • Mortality [ Time Frame: 90 Day ] [ Designated as safety issue: No ]
    Mortality at day 90


Secondary Outcome Measures:
  • Mortality [ Time Frame: 28 day ] [ Designated as safety issue: No ]
    28 day mortality

  • Persistent Organ Dysfunction combined with death [ Time Frame: day 28 ] [ Designated as safety issue: No ]
    Persistent Organ Dysfunction combined with death at 28

  • Days alive and free of mechanical ventilation [ Time Frame: day 90 post randomisation ] [ Designated as safety issue: No ]
  • Day alive and free of renal replacement therapy. [ Time Frame: day 90 post randomisation ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: October 2012
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard of care
Standard of care- oldest blood.
Other: Blood transfusion
Blood transfusion in ICU patients aged 18 and over.
Arm B
Freshest blood.
Other: Blood transfusion
Blood transfusion in ICU patients aged 18 and over.

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 outcome

  1. 28 day mortality
  2. Persistent Organ Dysfunction combined with death at 28 [47]
  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 [48]
  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 [49]
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01638416

Contacts
Contact: Bridget Ady +61 3 9903 0035 bridget.ady@monash.edu

Locations
Australia, Victoria
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Principal Investigator: Jamie Cooper, Professor         
Sponsors and Collaborators
Australian and New Zealand Intensive Care Research Centre
Australian Red Cross Blood Service
  More Information

Additional Information:
No publications provided by Australian and New Zealand Intensive Care Research Centre

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David James Cooper, Professor, Australian and New Zealand Intensive Care Research Centre
ClinicalTrials.gov Identifier: NCT01638416     History of Changes
Other Study ID Numbers: ANZICRCDJC006
Study First Received: July 9, 2012
Last Updated: July 18, 2013
Health Authority: Australia: Therapeutic Goods Association

ClinicalTrials.gov processed this record on October 23, 2014