Contact information
Type
Scientific
Primary contact
Prof Nancy Heddle
ORCID ID
Contact details
McMaster Transfusion Research Program
HSC-3H50
1200 Main St West
Hamilton
L8N 3Z5
Canada
+1 905 52591040 ext 22126
heddlen@mcmaster.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effects of transfusing fresh versus standard-issue red cells on in-hospital mortality: a pilot randomised controlled trial using a pragmatic approach
Acronym
INFORM
Study hypothesis
Hundreds 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
The Research Ethics Board at Hamilton Health Sciences approved on the 20th April 2010 (ref: 10-196)
Study design
Single centre pilot pragmatic double blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet.
Condition
Red cell blood transfusion
Intervention
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 (oldest product in stock)
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
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 outcome measures
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.
Overall trial start date
01/01/2010
Overall trial end date
01/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
1320
Participant 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
Recruitment start date
01/01/2010
Recruitment end date
01/12/2010
Locations
Countries of recruitment
Canada
Trial participating centre
McMaster Transfusion Research Program
Hamilton
L8N 3Z5
Canada
Sponsor information
Organisation
McMaster University (Canada)
Sponsor details
1200 Main Street West
Hamilton
Ontario
L8N 3Z5
Canada
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 221072)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Canadian Blood Services (Canada)
Alternative name(s)
CBS
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Canada
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22257314
Publication citations
-
Results
Heddle NM, Cook RJ, Arnold DM, Crowther MA, Warkentin TE, Webert KE, Hirsh J, Barty RL, Liu Y, Lester C, Eikelboom JW, The effect of blood storage duration on in-hospital mortality: a randomized controlled pilot feasibility trial., Transfusion, 2012, 52, 6, 1203-1212, doi: 10.1111/j.1537-2995.2011.03521.x.