Condition category
Haematological Disorders
Date applied
23/11/2011
Date assigned
16/02/2012
Last edited
03/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Transfusion of red blood cells is life-saving; however, recent data suggests that transfusion of stored blood may also cause some harm. Transfusion of red blood cells stored for up to 42 days is standard medical practice. Recent studies have suggested the changes that develop during red blood cell storage might contribute to increased risk in some patients; however, the results have generated significant controversy. In order to resolve the controversy, several studies are currently underway in very specific patient populations (critical care patients, patients undergoing cardiac surgery) comparing very fresh blood (less than 8 to 10 days of storage, with standard issue blood. The study we will perform will include all hospital patients receiving transfusion and does not use a specific storage age to define fresh blood; hence, it will provide information that will apply to all transfused patients. This study aims to determine the effect on in-hospital death rates of transfusing the freshest available blood compared with standard-issue blood.

Who can participate?
All adults (18 years of age or older) patients admitted to the hospital who will receive a transfusion during their stay are potentially eligible for the study.

What does this study involve?
The participant will not be contacted during this study. The decision to transfuse is determined by the patient's doctor. Once the ward orders the blood, the Transfusion Medicine Service will randomly allocate the patient to receive either the freshest available or standard-issue blood. The patient's data will be collected electronically. An information brochure will be distributed to the patient so they are made aware of the study.

What are the possible benefits and risks of participating?
As of yet, there are no direct known benefits for the participating patients. Future societal benefits may occur from this study depending on the study findings. There are no added risks of participating in this study. The decision to transfuse a patient happens independently of the study.

Where is the study run from?
The study is run from the McMaster Transfusion Medicine Program at McMaster University in Hamilton, Canada. Patients are recruited from Hamilton General Hospital (Canada), Juravinski Hospital (Canada), Flinders Medical Centre (Australia), St Joseph's Healthcare in Hamilton (Canada) and the Cleveland Clinic (USA).

When is the study starting and how long is it expected to run for?
We started the study in April 2012 at two sites in Canada and one in Australia. Later an additional site started the study in Canada and in the USA. We expect that the study will run for about 3 years.

Who is funding the study?
The study is funded by the Canadian Institutes of Health Research (CIHR) for a total of 3 years.

Who is the main contact?
Rebecca Barty, MLT,BA. MSC (c)
Clinical Research Coordinator
bartyr@mcmaster.ca

Trial website

Contact information

Type

Scientific

Primary contact

Ms Rebecca Barty

ORCID ID

Contact details

Clinical Research Coordinator
McMaster Transfusion Research Program
McMaster University Faculty of Health Sciences Department of Medicine
HSC-3H50
1280 Main Street West
Hamilton
L8S 4K1
Canada
+1 (0)905 525 9140 ext. 22945
bartyr@mcmaster.ca

Type

Scientific

Additional contact

Dr John Eikelboom

ORCID ID

Contact details

Department of Medicine
Hematology +Thromboembolism
HHSC
Hamilton General Hospital
Hamilton
L8L 2X2
Canada
+1 (0)905 521 2100 x44768
eikelbj@mcmaster.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Sept122011

Study information

Scientific title

INforming Fresh versus Old Red cell Management (INFORM): a large simple phase III randomized controlled trial

Acronym

INFORM

Study hypothesis

The freshest available compared with standard-issue blood reduces mortality.

Pilot study registered under ISRCTN38768001.

Added 14/08/2014:
The INFORM study started recruiting on 02/04/2012 at Hamilton General Hospital (Canada), Juravinski Hospital (Canada) and Flinders Medical Centre (Australia). Two additional hospitals have since joined the study: St. Joseph's Healthcare in Hamilton (Canada) started the study on 07/11/2012, and the Cleveland Clinic (USA) started the study on 07/01/2013. The Cleveland Clinic stopped randomization on 05/08/2014.

Ethics approval

1. Hamilton Health Sciences/Faculty of Health Sciences, Research Ethics Board, 16/08/2011
2. Southern Adelaide Clinical Human Research Ethics Committe, 15/08/2011
3. Cleveland Clinic, Institutional Review Board, 11/06/2012
4. St Joseph's Healthcare, Research Ethics Board, 17/05/2012

Study design

Multi-centre international randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Requiring a red blood cell transfuion

Intervention

Patients requiring red blood cell transfusion will be randomized to one of the following conditions:
1. Freshest available red blood cells (experiment arm)
2. Standard-issue (oldest product compatible in stock) red blood cells available (control arm)
Both arms (experiment and control) are within standard care

Intervention type

Biological/Vaccine

Phase

Drug names

Primary outcome measures

In-hospital mortality

Secondary outcome measures

Time to event (death)

Overall trial start date

16/01/2012

Overall trial end date

20/11/2015

Reason abandoned

Eligibility

Participant inclusion criteria

All adult patients (age >/= 18) will be included if:
1. Hospitalized at a participating centre (in-patient)
2. Undergoing a red cell transfusion

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

31,497

Participant exclusion criteria

1. Specific requirement for fresh blood (e.g., sickle cell disease, transfuion-dependent thalassemia, fresh cells ordered by care provider)
2. Pre-planned directed or autologous donation
3. Request for un-crossmatched blood
4. Anticipated massive transfusion as communicated from clinical area

Recruitment start date

02/04/2012

Recruitment end date

30/09/2015

Locations

Countries of recruitment

Australia, Canada, Israel, United States of America

Trial participating centre

Hamilton General Hospital
-
Canada

Trial participating centre

Juravinski Hospital
-
Canada

Trial participating centre

Flinders Medical Centre
-
Australia

Trial participating centre

St Joseph's Healthcare Hamilton
-
Canada

Trial participating centre

Cleveland Clinic
-
United States of America

Trial participating centre

Meir Medical Center
-
Israel

Sponsor information

Organisation

McMaster University (Canada)

Sponsor details

c/o Nancy Heddle
1280 Main Street West
HSC-3H54
Hamilton
L8S4K1
Canada
+1 (905) 525 9140 ext 22126
heddlen@mcmaster.ca

Sponsor type

University/education

Website

http://fhs.mcmaster.ca/mtrp/

Funders

Funder type

Government

Funder name

Canadian Institutes of Health Research (CIHR) (Canada)

Alternative name(s)

Instituts de Recherche en Santé du Canada, CIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Canada

Results and Publications

Publication and dissemination plan

Investigators currently are preparing a study design manuscript.

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26651419

Publication citations

Additional files

Editorial Notes

03/03/2016: Publication reference added. On 05/01/2015 the overall trial end date was changed from 01/09/2015 to 20/11/2015. On 04/11/2014 the following changes were made to the trial record: 1. The target number of participants was changed from 24,400 to 31,497. 2. The overall trial end date was changed from 30/09/2014 to 01/09/2015.