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

ISRCTN ISRCTN38768001
DOI https://doi.org/10.1186/ISRCTN38768001
Secondary identifying numbers N/A
Submission date
04/08/2010
Registration date
11/01/2011
Last edited
24/08/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Nancy Heddle
Scientific

McMaster Transfusion Research Program
HSC-3H50
1200 Main St West
Hamilton
L8N 3Z5
Canada

+1 905 52591040 ext 22126
heddlen@mcmaster.ca

Study information

Study designSingle centre pilot pragmatic double blind randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet.
Scientific titleEffects of transfusing fresh versus standard-issue red cells on in-hospital mortality: a pilot randomised controlled trial using a pragmatic approach
Study acronymINFORM
Study objectivesHundreds of thousands of Canadians receive a red cell transfusion each year. Current methods of blood inventory management are to issue the oldest blood first to limit outdating. However, data from experimental and observational studies suggest that red cells stored for longer periods might lead to adverse outcomes, including an increase in mortality. The only way to answer this question is to undertake a randomised controlled trial (RCT). If such a trial showed a statistically significant and clinically important improvement in mortality with freshest available versus standard issue red cells, it is likely to lead to major changes in the management of red cell inventories and storage methods to increase the use of fresher red cells. Such a large pragmatic trial is complex; hence before initiating a large trial it is important to work out logistics and show feasibility. Our proposed pilot study will provide crucial information for the design of a large RCT that will yield reliable and precise estimates of the effect of freshest available versus standard-issue red cells on in-hospital mortality.

Further reading:
Duration of red cell storage before transfusion and in-hospital mortality. Eikelboom JW, Cook RJ, Liu Y, Heddle NM. Am Heart J. 2010 May;159(5):737-743.e1.
http://www.ncbi.nlm.nih.gov/pubmed/20435180
Ethics approval(s)The Research Ethics Board at Hamilton Health Sciences approved on the 20th April 2010 (ref: 10-196)
Health condition(s) or problem(s) studiedRed cell blood transfusion
InterventionPatients 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 (oldest product in stock)
Intervention typeProcedure/Surgery
Primary outcome measureFeasibility 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 outcome measures1. 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.
Overall study start date01/01/2010
Completion date01/12/2010

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants1320
Key inclusion criteria1. 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.
Key exclusion criteria1. 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
Date of first enrolment01/01/2010
Date of final enrolment01/12/2010

Locations

Countries of recruitment

  • Canada

Study participating centre

McMaster Transfusion Research Program
Hamilton
L8N 3Z5
Canada

Sponsor information

McMaster University (Canada)
University/education

1200 Main Street West
Hamilton, Ontario
L8N 3Z5
Canada

http://www.mcmaster.ca/
ROR logo https://ror.org/02fa3aq29

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 221072)

No information available

Canadian Blood Services (Canada)
Private sector organisation / Other non-profit organizations
Alternative name(s)
Société canadienne du sang, CBS
Location
Canada

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2012 Yes No
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