Condition category
Pregnancy and Childbirth
Date applied
02/10/2006
Date assigned
02/10/2006
Last edited
16/10/2012
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

Dr Dean A Fergusson

ORCID ID

Contact details

Clinical Epidemiology Program
Ottawa Hospital Research Institute
501 Smyth Road
Box 201
Ottawa
Ontario
K1H 8L6
Canada
+1 613 737 8480
dafergusson@ohri.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00326924

Protocol/serial number

MCT-75527

Study information

Scientific title

Age of Red blood cells In Premature Infants: a multicentre, two arm, randomised parallel trial

Acronym

ARIPI

Study hypothesis

The transfusion of red blood cells (RBCs) stored for less than or equal to seven days will decrease the incidence of a 90-day composite measure consisting of all-cause mortality and organ dysfunction including bronchopulmonary dysplasia, necrotising enterocolitis, intraventricular haemorrhage and retinopathy of prematurity in premature infants weighing less than or equal to 1250 grams.

Ethics approval

Research Ethics Board of The Ottawa Hospital, Ottawa, Ontario (Canada) approved on the 14th June 2006.

Study design

Multicentre, two arm, randomised parallel trial with study participant, investigator, caregiver, outcome assessor and data analyst blinded

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 the contact details below to request a patient information sheet

Condition

Premature infants weighing less than 1250 g admitted to the neonatal intensive care unit

Intervention

Experimental Group: transfusion of fresh blood stored less than or equal to seven days. Control Group: standard practice (blood stored up to 35 days).

In all sites but Saskatoon, O-Rh negative RBCs will be divided into satellite units of between four and eight aliquots, and these aliquots will be removed from their satellite units as needed in order to reduce wastage. Dose as per standard care/duration: up to 90 days.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Composite outcome comprised of five major neonatal morbidities:
1. Necrotising enterocolitis
2. Retinopathy of prematurity
3. Bronchopulmonary dysplasia
4. Intraventricular hemorrhage
5. Mortality measured at 90 days

Secondary outcome measures

1. Nosocomial infection
2. Individual rates of the morbidities comprising the primary outcome:
2.1. Necrotising enterocolitis
2.2. Retinopathy of prematurity
2.3. Bronchopulmonary dysplasia
2.4. Intraventricular hemorrhage
2.5. Death

Tertiary outcomes will include:
1. Length of mechanical ventilation
2. Length of stay in the NICU
3. Both minor and major interventions received while in the NICU

Overall trial start date

01/05/2006

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Requirement of a second allogeneic RBC transfusion for the treatment of prematurity
2. Infant age 0 - 27 days, either sex
3. Less than 1250 grams birth weight
4. Admitted to the participating Neonatal Intensive Care Unit (NICU)
5. Parents or guardian have signed (proxy) informed consent

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

450

Participant exclusion criteria

1. Infants whose first transfusion was older than seven days
2. Infants already given a second RBC transfusion
3. Infants scheduled to undergo an exchange transfusion
4. Infants that will receive directed donations
5. Infants that have rare blood types or difficulty with cross-matching
6. Infants whose proxy has refused consent
7. Infants who are moribund upon admission to the NICU or not expected to survive due to a severe congenital anomaly

Recruitment start date

01/05/2006

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Canada

Trial participating centre

Clinical Epidemiology Program
Ontario
K1H 8L6
Canada

Sponsor information

Organisation

Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute

Sponsor details

725 Parkdale Avenue
Ottawa
Ontario
K1Y 4E9
Canada
+1 613 761 4395
info@ohri.ca

Sponsor type

Research organisation

Website

http://www.ohri.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-75527)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19056034
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23045213

Publication citations

  1. Results

    Fergusson DA, Hébert P, Hogan DL, LeBel L, Rouvinez-Bouali N, Smyth JA, Sankaran K, Tinmouth A, Blajchman MA, Kovacs L, Lachance C, Lee S, Walker CR, Hutton B, Ducharme R, Balchin K, Ramsay T, Ford JC, Kakadekar A, Ramesh K, Shapiro S, Effect of fresh red blood cell transfusions on clinical outcomes in premature, very low-birth-weight infants: the ARIPI randomized trial., JAMA, 2012, 308, 14, 1443-1451, doi: 10.1001/2012.jama.11953.

  2. Fergusson D, Hutton B, Hogan DL, LeBel L, Blajchman MA, Ford JC, Hebert P, Kakadekar A, Kovacs L, Lee S, Sankaran K, Shapiro S, Smyth JA, Ramesh K, Bouali NR, Tinmouth A, Walker R, The age of red blood cells in premature infants (ARIPI) randomized controlled trial: study design., Transfus Med Rev, 2009, 23, 1, 55-61, doi: 10.1016/j.tmrv.2008.09.005.

Additional files

Editorial Notes