Condition category
Surgery
Date applied
04/08/2010
Date assigned
11/01/2011
Last edited
24/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.mcmaster.ca/

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)

Société canadienne du sang, 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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22257314

Publication citations

  1. 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.

Additional files

Editorial Notes