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22 May 2013
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| [ Print-friendly version ] |
| Age of Red blood cells In Premature Infants trial |
| ISRCTN | ISRCTN65939658 |
| DOI | 10.1186/ISRCTN65939658 |
| ClinicalTrials.gov identifier | NCT00326924 |
| EudraCT number | |
| Public title | Age of Red blood cells In Premature Infants trial |
| Scientific title | Age of Red blood cells In Premature Infants: a multicentre, two arm, randomised parallel trial |
| Acronym | ARIPI |
| Serial number at source | MCT-75527 |
| 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. |
| Lay summary | Not provided at time of registration |
| 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 |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Premature infants weighing less than 1250 g admitted to the neonatal intensive care unit |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/05/2006 |
| Anticipated end date | 31/12/2009 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 450 |
| Interventions |
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. |
| Primary outcome measure(s) |
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 measure(s) |
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 |
| Sources of funding | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-75527) |
| Trial website | |
| Publications |
1. 2009 protocol in http://www.ncbi.nlm.nih.gov/pubmed/19056034
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23045213 |
| Contact name | Dr Dean A Fergusson |
| Address |
Clinical Epidemiology Program
Ottawa Hospital Research Institute 501 Smyth Road, Box 201 Ottawa |
| City/town | Ontario |
| Zip/Postcode | K1H 8L6 |
| Country | Canada |
| Tel | +1 613 737 8480 |
| Fax | +1 613 739 6266 |
| dafergusson@ohri.ca | |
| Sponsor | Ottawa Hospital Research Institute (OHRI) (Canada) - formerly Ottawa Health Research Institute |
| Address |
725 Parkdale Avenue
Ottawa |
| City/town | Ontario |
| Zip/Postcode | K1Y 4E9 |
| Country | Canada |
| Tel | +1 613 761 4395 |
| info@ohri.ca | |
| Sponsor website: | http://www.ohri.ca/ |
| Date applied | 02/10/2006 |
| Last edited | 16/10/2012 |
| Date ISRCTN assigned | 02/10/2006 |
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