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

ISRCTN	ISRCTN38768001
DOI	https://doi.org/10.1186/ISRCTN38768001
Protocol serial number	N/A
Sponsor	McMaster University (Canada)
Funders	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 221072), Canadian Blood Services (Canada)

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

Phone	+1 905 52591040 ext 22126
Email	heddlen@mcmaster.ca

Study information

Primary study design	Interventional
Study design	Single centre pilot pragmatic double blind randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Effects of transfusing fresh versus standard-issue red cells on in-hospital mortality: a pilot randomised controlled trial using a pragmatic approach
Study acronym	INFORM
Study objectives	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(s)	The Research Ethics Board at Hamilton Health Sciences approved on the 20th April 2010 (ref: 10-196)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/12/2010

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	All
Target sample size at registration	1320
Key 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.
Key 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
Date of first enrolment	01/01/2010
Date of final enrolment	01/12/2010

Locations

Countries of recruitment

Canada

Study participating centre

McMaster Transfusion Research Program

Hamilton
L8N 3Z5
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes