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Effects of transfusing fresh versus standard-issue red cells on in-hospital mortality

Effects of transfusing fresh versus standard-issue red cells on in-hospital mortality: a pilot randomised controlled trial using a pragmatic approach

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN38768001
Enrollment
1320
Registered
2011-01-11
Start date
2010-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Red cell blood transfusion Surgery

Interventions

Patients requiring red cell transfusion will be randomised to one of the following conditions: 1. Experimental transfusion is freshest available red cells 2. Control is standard issue red cells (oldes

Sponsors

McMaster University (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who are admitted to Hamilton General Hospital 2. Destined to receive a red cell transfusion 3. Either sex, no age restrictions The REB has approved that this study to be done with waived consent as it meets the 5 requirements for waived consent identified by the Tri Council Policy. However, to meet all requirements of this policy, patients will be informed that this study is taking place and will be given a summary of the study.

Exclusion criteria

Exclusion criteria: 1. Patients who have a particular requirement for fresh red cells (e.g., sickle cell disease, transfusion dependent thalassemia, fresh cells requested by physician) 2. Are to receive pre-planned directed or autologous donations 3. Massive transfusion anticipated 4. Being transfused as an outpatient

Design outcomes

Primary

MeasureTime frame
Feasibility of randomising consecutive patients requiring blood transfusion: we anticipate that early in the study the failure rate may be higher due to the learning curve associated with the randomisation process; hence, the feasibility failure rate will be assessed on the data from the final 3 months of the 6 months pilot. This outcome will be monitored weekly with changes being implemented to prevent failures from occurring if possible. This is vital information in determining the feasibility of the larger RCT.

Secondary

MeasureTime frame
1. Impact on inventory and red cell outdating rate 2. Contrast in the age of fresh and standard-issue red cells 3. Ability to provide timely reports to monitor inventory levels 4. Outdating and age overlap The frequency of in-hospital mortality will also be documented but used only to estimate the sample size for expanding the study if feasibility is demonstrated.

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026