Age of Red Blood Cells in Premature Infants Study (ARIPI)

NCT ID: NCT00326924

Last Updated: 2018-01-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

377 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2012-06-30

Brief Summary

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To determine if the age of blood transfused to new borns in the NICU setting has an impact on their outcome.

Detailed Description

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Conditions

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Premature Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Biological

PRBCs that are less than 7 days old are considered 'fresh'.

Group Type EXPERIMENTAL

Transfusion

Intervention Type BIOLOGICAL

PRBC blood transfusions.

Standard PRBCs

PRBCs 'stored' as per hospital policy.

Group Type EXPERIMENTAL

Transfusion

Intervention Type BIOLOGICAL

PRBC blood transfusions.

Interventions

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Transfusion

PRBC blood transfusions.

Intervention Type BIOLOGICAL

Other Intervention Names

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non applicable

Eligibility Criteria

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Inclusion Criteria

* birthweight of less than 1250g
* admitted to participating NICU
* consent acquired from proxy for the patient

Exclusion Criteria

* already received one or more transfusions
* requirement for an exchange transfusion
* will be receiving directed donations
* have rare blood types/difficult cross-match
* proxy has refused consent
* moribund on admission to NICU/expected to die
* mitigating child protection issues
Minimum Eligible Age

1 Minute

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dean Fergusson, PhD

Role: STUDY_DIRECTOR

OHRI

Locations

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Ottawa Hospital

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

References

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Kekre N, Mallick R, Allan D, Tinmouth A, Tay J. The impact of prolonged storage of red blood cells on cancer survival. PLoS One. 2013 Jul 16;8(7):e68820. doi: 10.1371/journal.pone.0068820. Print 2013.

Reference Type DERIVED
PMID: 23874777 (View on PubMed)

Fergusson DA, Hebert 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 Oct 10;308(14):1443-51. doi: 10.1001/2012.jama.11953.

Reference Type DERIVED
PMID: 23045213 (View on PubMed)

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 Jan;23(1):55-61. doi: 10.1016/j.tmrv.2008.09.005.

Reference Type DERIVED
PMID: 19056034 (View on PubMed)

Other Identifiers

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2004706-01H

Identifier Type: -

Identifier Source: org_study_id

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