Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
424 participants
INTERVENTIONAL
2001-02-28
2005-11-30
Brief Summary
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Primary Objective: To determine whether either a liberal or more restrictive threshold of hemoglobin level for red cell transfusion in ELBW infants is safer, by randomizing to either a high transfusion hemoglobin threshold or a low transfusion hemoglobin threshold.
Follow-up at a corrected age of 18 months represents a conventional age at which to first assess neurodevelopmental outcomes, and to predict long-term outcomes.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Red blood cell transfusion
Eligibility Criteria
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Inclusion Criteria
* postnatal age \<48 hours
* no transfusion beyond first 6 hours of life
* estimated gestational age of 30 completed weeks or less
Exclusion Criteria
* infant has cyanotic congenital heart disease
* infant's parents known to be opposed to blood transfusion
* either parent has hemoglobinopathies or congenital anemias
* infant has hemolytic disease
* infant has severe acute hemorrhage, severe shock, severe sepsis with coagulopathy or requires peri-operative transfusion
* prior treatment with or intention to treat with erythropoietin
48 Hours
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
McMaster University
OTHER
Principal Investigators
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Haresh Kirpalani, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Robin K Whyte, MD
Role: PRINCIPAL_INVESTIGATOR
Dalhousie University
Robin S Roberts, MTech
Role: STUDY_DIRECTOR
McMaster University
Elizabeth Asztalos, MD, MSc
Role: STUDY_DIRECTOR
Sunnybrook & Women's College Health Sciences Centre
Chad Andersen, MD
Role: STUDY_DIRECTOR
Mercy Hospital for Women
Morris Blajchman, PhD
Role: STUDY_DIRECTOR
McMaster University
Nancy Heddle, MSc
Role: STUDY_DIRECTOR
McMaster University
Locations
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Albany Medical Center
Albany, New York, United States
Brooklyn Hospital Center
Brooklyn, New York, United States
Royal Women's Hospital
Melbourne, Victoria, Australia
Mercy Hospital for Women
Melbourne, Victoria, Australia
Royal Alexandra Hospital
Edmonton, Alberta, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
McMaster University
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada
Sunnybrook & Women's College Health Science Centre
Toronto, Ontario, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
Countries
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References
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Kirpalani H, Whyte RK, Andersen C, Asztalos EV, Heddle N, Blajchman MA, Peliowski A, Rios A, LaCorte M, Connelly R, Barrington K, Roberts RS. The Premature Infants in Need of Transfusion (PINT) study: a randomized, controlled trial of a restrictive (low) versus liberal (high) transfusion threshold for extremely low birth weight infants. J Pediatr. 2006 Sep;149(3):301-307. doi: 10.1016/j.jpeds.2006.05.011.
Whyte RK, Kirpalani H, Asztalos EV, Andersen C, Blajchman M, Heddle N, LaCorte M, Robertson CM, Clarke MC, Vincer MJ, Doyle LW, Roberts RS; PINTOS Study Group. Neurodevelopmental outcome of extremely low birth weight infants randomly assigned to restrictive or liberal hemoglobin thresholds for blood transfusion. Pediatrics. 2009 Jan;123(1):207-13. doi: 10.1542/peds.2008-0338.
Other Identifiers
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CIHR MCT-41549
Identifier Type: -
Identifier Source: secondary_id
CIHR MCT-58455
Identifier Type: -
Identifier Source: secondary_id
CTMG-2001-PINT
Identifier Type: -
Identifier Source: org_study_id
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