Informing fresh versus standard Issue red cell management
| ISRCTN | ISRCTN08118744 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN08118744 |
| Secondary identifying numbers | Sept122011 |
- Submission date
- 23/11/2011
- Registration date
- 16/02/2012
- Last edited
- 01/03/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Plain English summary of protocol
Background and study aims
Transfusion of red blood cells is life-saving, but 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, but 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. This study 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?
January 2012 to November 2015
Who is funding the study?
Canadian Institutes of Health Research (CIHR) (Canada)
Who is the main contact?
Rebecca Barty
bartyr@mcmaster.ca
Contact information
Scientific
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
| Phone | +1 (0)905 525 9140 ext. 22945 |
|---|---|
| bartyr@mcmaster.ca |
Scientific
Department of Medicine
Hematology +Thromboembolism
HHSC, Hamilton General Hospital
Hamilton
L8L 2X2
Canada
| Phone | +1 (0)905 521 2100 x44768 |
|---|---|
| eikelbj@mcmaster.ca |
Study information
| Study design | Multi-centre international randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet |
| Scientific title | INforming Fresh versus Old Red cell Management (INFORM): a large simple phase III randomized controlled trial |
| Study acronym | INFORM |
| Study objectives | The freshest available compared with standard-issue blood reduces mortality. Pilot study registered under ISRCTN38768001. |
| Ethics approval(s) | 1. Hamilton Health Sciences/Faculty of Health Sciences, Research Ethics Board, 16/08/2011 2. Southern Adelaide Clinical Human Research Ethics Committee, 15/08/2011 3. Cleveland Clinic, Institutional Review Board, 11/06/2012 4. St Joseph's Healthcare, Research Ethics Board, 17/05/2012 |
| Health condition(s) or problem(s) studied | Red blood cell transfusion |
| 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 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. |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | In-hospital mortality |
| Secondary outcome measures | Time to event (death) |
| Overall study start date | 16/01/2012 |
| Completion date | 20/11/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 31,497 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 02/04/2012 |
| Date of final enrolment | 30/09/2015 |
Locations
Countries of recruitment
- Australia
- Canada
- Israel
- United States of America
Study participating centres
Canada
Canada
Australia
Canada
United States of America
Israel
Sponsor information
University/education
c/o Nancy Heddle
1280 Main Street West
HSC-3H54
Hamilton
L8S4K1
Canada
| Phone | +1 (905) 525 9140 ext 22126 |
|---|---|
| heddlen@mcmaster.ca | |
| Website | http://fhs.mcmaster.ca/mtrp/ |
"ROR" |
https://ror.org/02fa3aq29 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
- Location
- Canada
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Investigators currently are preparing a study design manuscript. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/01/2016 | Yes | No | |
| Results article | results | 17/11/2016 | Yes | No | |
| Other publications | secondary analysis | 01/11/2017 | Yes | No |
Editorial Notes
01/03/2019: Internal review.
19/10/2017: Publication references added.
03/03/2016: Publication reference added.
05/01/2015: The overall trial end date was changed from 01/09/2015 to 20/11/2015.
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.
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.
