Table 1 World Health Organization trial registration dataset
Primary registry and trial identifying number | ClinicalTrials.gov, ID: NCT01977547 |
Date of registration in primary registry | 5 November 2013 |
Secondary identifying numbers | None |
Source(s) of monetary or material support | 1. National Heart, Lung and Blood Institute (Grant #1U01HL116383–01);2. Canadian Institutes of Health Research (Grant #126113), Ottawa, ON, Canada; 3. Comité National de la Recherche Clinique, Département de la Recherche Clinique et du Développement (DRCD), Assistance Publique – Hôpitaux de Paris, Ministère des Solidarités, de la Santé et de la Famille, France; 4. Ministère des Affaires Sociales et de la Santé, Paris, France (PHRC 14–0390); 5. The Ministère de la Santé et des Services Sociaux de la Province de Québec; and 6. Department of Pediatrics, Washington University in St. Louis, St. Louis, MO, USA |
Primary sponsor | Investigator-initiated study Philip C. Spinella MD, FCCM Associate Professor of Pediatrics Division of Pediatric Critical Care Washington University in St. Louis St. Louis Children’s Hospital Campus Box 8116 One Children’s Place/NWT 10th fl. St. Louis, MO 63110, USA Phone: (314) 286–0858 Email: spinella_p@kids.wustl.edu |
Marisa Tucci MD Full Professor of Pediatrics Division of Pediatric Critical Care CHU Sainte-Justine Université de Montréal 3175 Côte Sainte-Catherine Montreal, QC Canada H3T 1C5 Phone: (514) 345–4931 × 3261 Email: marisa.tucci@recherche-ste-justine.qc.ca | |
Secondary sponsor(s) | Washington University in St. Louis St. Louis Children’s Hospital CHU Sainte-Justine Université de Montréal |
Contact for public queries | Philip C. Spinella MD, FCCM, Washington University in St. Louis, St. Louis Children’s Hospital, Campus Box 8116, One Children’s Place/NWT 10th fl., St. Louis, MO 63110, USA Phone: (314) 286–0858 Email: spinella_p@kids.wustl.edu |
Marisa Tucci, MD, Sainte-Justine Hospital, 3175 Côte Sainte-Catherine, Montreal, QC, Canada H3T 1C5 Phone: (514) 345–4931 × 3261 Email: marisa.tucci@recherche-ste-justine.qc.ca | |
Contact for scientific queries | Philip C. Spinella MD, FCCM, Washington University in St. Louis, St. Louis Children’s Hospital, Campus Box 8116, One Children’s Place/NWT 10th fl., St. Louis, MO 63110, USA Phone: (314) 286–0858 Email: spinella_p@kids.wustl.edu |
Marisa Tucci, MD, Sainte-Justine Hospital, 3175 Côte Sainte-Catherine, Montreal, QC, Canada H3T 1C5 Phone: (514) 345–4931 × 3261 Email: marisa.tucci@recherche-ste-justine.qc.ca | |
Public title | Age of Blood in Children in Pediatric Intensive Care Units |
Scientific title | The Age of Blood in Pediatric Intensive Care Units (ABC PICU) Randomized Clinical Trial |
Countries of recruitment | Canada, US, France, Italy, Israel |
Health condition(s) or problem(s) studied | Impact of red blood cell storage time on multiple organ dysfunction syndrome in critically ill children |
Intervention(s) | Transfusion with either RBCs stored for ≤ 7 days or standard-issue red blood cells (oldest in inventory) |
Key inclusion and exclusion criteria | Eligible for study: 1. a first RBC transfusion is requested within the first 7 days (168 h) of PICU admission; or 2. patient assessed pre-operatively and for whom PICU admission is planned post-operatively, and who is determined to definitively require a first RBC transfusion during surgery Inclusion criteria: critically ill pediatric patients who have an expected length of stay after transfusion in the ICU > 24 h based on the best judgment of the attending ICU staff Exclusion criteria: age at ICU entry < 3 days from birth or > 16 years of age; post-conception age < 36 weeks on admission to ICU; documented RBC transfusion within the 28 days prior to fulfilling the eligibility criteria; previously randomized in this study; weight < 3.0 kg on ICU admission; pregnant; conscious objection or unwillingness to receive blood products; not expected to survive beyond 24 h, brain death or suspected brain death; limitation or withdrawal of care decisions have been made; enrollment in another randomized clinical trial which has not been approved for co-enrollment; patients for whom autologous and/or directed donation RBCs will be provided; patients for whom the treating physician routinely and systematically requests RBC ≤ 14 days of storage; patients for whom there systematically exist RBC aliquoting policies that mandate the initial use of units stored for ≤ 14 days; on ECMO or plan to be immediately placed on ECMO at time of enrollment; patient predicted or presumed to require a massive transfusion (> 40 ml/kg of all blood components in a 24-h period) according to treating physician judgment; refusal by physician; inability to obtain consent; blood bank personnel experiences difficulties in securing blood products (difficult cross matches, rare blood groups, and diseases like IgA deficiency); insufficient number of ABO type compatible RBC units available in the blood bank at randomization with a storage time ≤ 7 days (minimum 1 unit regardless of patient age); all RBC units available for the patient are not leukocyte-reduced prior to storage |
Study type | Multicenter, double blind, randomized controlled trial |
Date of first enrollment | 1 February 2013 |
Target sample size | 1538 |
Recruitment status | Recruiting |
Primary outcome | New or progressive multiple organ dysfunction syndrome |
Key secondary outcomes | PICU and hospital mortality, 28-day, and 90-day all-cause mortality, nosocomial infections, PELOD-2 score, severe sepsis, septic shock, acute respiratory distress syndrome (ARDS), mechanical ventilation and PICU-free days |
Ethics review | Approval obtained from the Institutional Review Board / Research Ethics Board of all participating sites and were in accordance with the institutional policies of the US Department of Health and Human Services in the US, provincial legislation in Canada, and appropriate entities in France, Italy, and Israel |
Estimated completion date | June 2018 |