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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05405426
Registration number
NCT05405426
Ethics application status
Date submitted
2/05/2022
Date registered
6/06/2022
Titles & IDs
Public title
Trial of Indication-Based Transfusion of Red Blood Cells in ECMO
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Scientific title
TITRE: Trial of Indication-Based Transfusion of Red Blood Cells in ECMO
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Secondary ID [1]
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W81XWH-22-1-0301
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Universal Trial Number (UTN)
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Trial acronym
TITRE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Extracorporeal Membrane Oxygenation
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Red Blood Cell Transfusion
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Organ Failure, Multiple
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Condition category
Condition code
Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Red blood cell transfusion
Active comparator: Indication-based red blood cell transfusion strategy - Red blood cell transfusion will occur if the center-specific hemoglobin/hematocrit threshold for transfusion is met AND at least one of the following conditions is present: a) moderate or severe bleeding; b) reduced tissue oxygen delivery, defined as serum lactate \>5 mmol/L or 2 serum lactate levels \> 3 mmol/L measured 2 hours apart; or c) hemoglobin \< 8 g/dL or hematocrit \< 25%, except for neonates (age =\< 28 d) and children with single ventricle congenital heart disease (age \< 1 y) RBC transfusion for hemoglobin \< 10g/dL or hematocrit \<30% is allowed.
Other: Center-specific hemoglobin/hematocrit threshold-based red blood cell transfusion strategy - Red blood cell transfusion will occur according to each study center's standard of care strategy, typically based on a particular hemoglobin threshold or hematocrit threshold. When hemoglobin or hematocrit decrease to the threshold, red blood cell transfusion is administered.
Other interventions: Red blood cell transfusion
The intervention is a strategy for when red blood cell transfusion will be administered (see description of Arms). However, volume of RBC transfused in the two arms is not specified by this study. Red blood cell transfusion strategy for ECMO weaning and decannulation is not specified by this study. Red blood cell transfusion after ECMO decannulation is not specified by this study.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Baseline-adjusted change in pSOFA (pediatric Sequential Organ Failure Assessment) score
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Assessment method [1]
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The pSOFA score ranges from 0 (no organ dysfunction) through 24 (severe dysfunction in all 6 organs assessed). If death occurs during ECMO within 30 days, a score of 24 is assigned.
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Timepoint [1]
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At randomization and at 30 days post-randomization (or up to time of ECMO decannulation if earlier; varies according to patient)
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Primary outcome [2]
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Bayley Infant Scales of Development, 4th edition (Bayley-4)
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Assessment method [2]
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Scales for Cognitive, Language (Expressive and Receptive), Motor (Gross and Fine), and Social-Emotional. For ages 16 days to 42 months. Composite score range is 40 to 160.
Higher scores indicate better performance.
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Timepoint [2]
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One year post-randomization (+/- 2 mo)
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Primary outcome [3]
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Wechsler Preschool and Primary Scale of Intelligence (WPPSI - IV)
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Assessment method [3]
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Index scores include Verbal Comprehension, Visual Spatial, Working Memory, and Full Scale Intelligence Quotient (IQ). Score range is 40 to 160. Higher scores indicate better performance.
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Timepoint [3]
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One year post-randomization (+/-2 mo)
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Secondary outcome [1]
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Mixed venous oxygen saturation
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Assessment method [1]
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Oxygen content of blood that returns to the heart after meeting tissue needs
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Timepoint [1]
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Daily AM (6 AM - 12 AM), during ECMO (up to 30 days post-randomization, whichever is earlier)
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Secondary outcome [2]
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Total volume of blood products administered
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Assessment method [2]
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Packed RBC and whole blood, cryoprecipitate, plasma, platelets
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Timepoint [2]
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30 days post-randomization (or up to time of ECMO decannulation if earlier; varies according to patient)
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Secondary outcome [3]
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Presence vs. absence of hospital-acquired Infection
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Assessment method [3]
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Nosocomially-acquired infection that is not present or incubating at the time of admission to hospital
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Timepoint [3]
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30 days post-randomization (up to time of ECMO decannulation if earlier; varies according to patient)
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Secondary outcome [4]
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Daily renal function
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Assessment method [4]
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Serum creatinine, blood urea nitrogen (BUN)
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Timepoint [4]
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Daily up to 30 days post-randomization (or up to time of ECMO decannulation if earlier; varies according to patient)
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Secondary outcome [5]
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Acute kidney injury > stage 2
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Assessment method [5]
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Kidney Disease Improving Global Outcomes (KDIGO) definition
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Timepoint [5]
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30 days post-randomization (up to time of ECMO decannulation if earlier; varies according to patient)
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Secondary outcome [6]
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Number of ECMO circuit component replacements
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Assessment method [6]
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Replacement of oxygenator and/or pump
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Timepoint [6]
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At 30 days post-randomization
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Secondary outcome [7]
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Presence vs. absence of hemolysis
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Assessment method [7]
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According to plasma hemoglobin values
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Timepoint [7]
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Daily up to 30 days post-randomization (or up to time of ECMO decannulation if earlier; varies according to patient)
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Secondary outcome [8]
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All-cause mortality
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Assessment method [8]
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Death from any cause
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Timepoint [8]
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30 days, in-hospital, and 1 year post-randomization
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Secondary outcome [9]
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Number of ICU-free days
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Assessment method [9]
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Minimum value is zero, maximum value is 60 minus ICU length of stay
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Timepoint [9]
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At 60 days post-randomization
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Secondary outcome [10]
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Number of hospital-free days
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Assessment method [10]
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Minimum value is zero, maximum value is 60 minus hospital length of stay
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Timepoint [10]
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At 90 days post-randomization
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Secondary outcome [11]
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Discharge location
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Assessment method [11]
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Home vs. rehabilitation facility
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Timepoint [11]
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At time of hospital discharge (assessed up to 1 year)
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Secondary outcome [12]
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Adaptive Behavior Assessment System-3 (ABAS-3)
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Assessment method [12]
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Composite scores for overall adaptive functioning (General Adaptive Composite, GAC), Conceptual, Social and Practical domains as well as nine subscales. Higher score indicates better behavior.
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Timepoint [12]
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1 year post-randomization (+/- 2 mo)
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Secondary outcome [13]
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Child Behavior Checklist (CBCL)
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Assessment method [13]
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Parent-report; child minimum age 1.5 years. Higher score indicates worse behavior.
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Timepoint [13]
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1 year post-randomization (+/- 2 mo)
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Secondary outcome [14]
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Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0)
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Assessment method [14]
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Parent-report; child minimum age 2.0 years. Higher score indicates better quality of life.
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Timepoint [14]
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9 months post-randomization (+/- 1 mo)
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Secondary outcome [15]
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Pediatric Quality of Life Inventory Cardiac Module
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Assessment method [15]
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Parent-report; child minimum age 2.0 years. To be completed for participants with a congenital heart disease diagnosis. Higher score indicates better quality of life.
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Timepoint [15]
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9 months post-randomization (+/- 1 mo)
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Secondary outcome [16]
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Number of Donor Exposures
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Assessment method [16]
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Number of Donor Exposures for RBC transfusion
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Timepoint [16]
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Daily up to 30 days post-randomization (or up to time of ECMO decannulation if earlier; varies according to patient)
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Secondary outcome [17]
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Recannulation for ECMO < 48 hours and < 72 hours after decannulation
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Assessment method [17]
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No: of patients recannulated for ECMO within 48 hours and 72 hours post-decannulation
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Timepoint [17]
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From ECMO decannulation hour to 72 hours following ECMO decannulation
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Secondary outcome [18]
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ECMO duration
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Assessment method [18]
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ECMO duration in hours: Time period from ECMO cannulation to first successful ECMO decannulation in hours. Time accrued during ECMO for additional ECMO runs (i.e. those cannulated within 36 hours following first decannulation) will be included as total ECMO duration
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Timepoint [18]
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During Hospitalization: From ECMO cannulation to ECMO decannulation, death, transition to Ventricular Assist Device (VAD) or 365 days post-randomization, whichever is earliest
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Secondary outcome [19]
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Duration of mechanical ventilation post-randomization
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Assessment method [19]
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Duration of mechanical ventilation post-randomization in hours: Randomization to first successful extubation from mechanical ventilation hours; for patients with tracheostomy that require mechanical ventilatory support at the time of ICU discharge: time of ICU discharge to compute mechanical ventilation duration.
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Timepoint [19]
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During Hospitalization: From Randomization to Extubation from Mechanical Ventilation, death, hospital discharge, or 365 days post-randomization, whichever is earliest
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Secondary outcome [20]
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Occurrence of Seizures
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Assessment method [20]
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Occurrence of electroencephalographic evidence of seizure prior to hospital discharge or within 90 d post randomization, whichever is earliest
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Timepoint [20]
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Randomization to Hospital Discharge or 90 days post-randomization, whichever is earliest
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Secondary outcome [21]
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Stroke or Intracranial Hemorrhage during ECMO
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Assessment method [21]
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Occurrence of brain infarction, intracranial hemorrhage, or ischemic injury during ECMO (composite) confirmed using head ultrasound and Computed Tomography (CT) during ECMO
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Timepoint [21]
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Time of ECMO cannulation to ECMO decannulation, death or 30 days post-randomization, whichever occurs first
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Secondary outcome [22]
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Stroke or Intracranial Hemorrhage prior to Hospital Discharge
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Assessment method [22]
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Proportion of patients with brain infarction, intracranial hemorrhage, or ischemic injury (composite) confirmed using head ultrasound, CT, or Magnetic Resonance Imaging (MRI) prior to hospital discharge or within 90 d post randomization, whichever is earliest
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Timepoint [22]
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ECMO cannulation to 90 days post-randomization or hospital discharge, whichever occurs first
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Secondary outcome [23]
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Pediatric Overall Performance Category (POPC)
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Assessment method [23]
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Pediatric Overall Performance (POPC; score range 0 to 6; Unit: categories on a scale; value: lower is better) at Hospital Discharge, 3, 6, 9, 12 months post-randomization.
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Timepoint [23]
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Randomization to study completion (completion of 12 month neurodevelopment assessment)
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Secondary outcome [24]
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Functional Status Score (FSS)
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Assessment method [24]
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Functional Status Score (FSS; score range 6 to 30; Unit: numerical value on a scale; lower is better) at hospital discharge, 3, 6, 9, 12 months post-randomization
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Timepoint [24]
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Randomization to study completion (completion of 12 month neurodevelopment assessment)
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Secondary outcome [25]
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ICU Length of Stay among survivors
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Assessment method [25]
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Duration of hospitalization in the ICU among survivors in days. For ICU readmissions only the only days in the first 2 ICU readmissions will be included
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Timepoint [25]
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ICU Admission to ICU discharge, death or 365 post-randomization, whichever occurs first
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Secondary outcome [26]
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Hospital length of stay among survivors
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Assessment method [26]
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Duration of hospitalization among survivors in days
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Timepoint [26]
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Hospital Admission to discharge death, or 365 days post-randomization, whichever occurs first
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Secondary outcome [27]
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Pediatric Cerebral Performance Category (PCPC)
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Assessment method [27]
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Pediatric Cerebral Performance Category (POPC; score range 0 to 6; Unit: categories on a scale, lower is better) at Hospital Discharge, 3, 6, 9, 12 months post-randomization.
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Timepoint [27]
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Randomization to study completion (completion of 12 month neurodevelopment assessment)
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Secondary outcome [28]
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Number of ICU readmissions prior to discharge from index hospitalization among survivors
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Assessment method [28]
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Number of ICU readmissions. ICU readmissions are defined as number of ICU admissions following discharge from the first ICU admission.
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Timepoint [28]
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Index ICU discharge to Hospital discharge or 365 days post-randomization, whichever occurs first
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Eligibility
Key inclusion criteria
1. Age < 6 year at ECMO cannulation
2. Veno-arterial (VA) mode of ECMO
3. First ECMO run during the index hospitalization
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Minimum age
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Day
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Maximum age
6
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Gestationally-corrected age < 37 weeks at the time of ECMO cannulation
2. Veno-venous (VV) mode of ECMO
3. Patients initially started on VV-ECMO and then transitioned to VA ECMO
4. ECMO used for procedural support (ECMO deployed and decannulated in procedural area with no ICU ECMO care)
5. ECMO duration expected to be < 24 h
6. Limitation of care or withdrawal of support discussed or in place after ECMO deployment
7. Congenital bleeding disorders
8. Hemoglobinopathies
9. Primary Residence outside country of enrollment
10. Concurrent participation in a separate interventional trial that has potential to impact neurodevelopment status of patient
11. Patients cannulated for ECMO at a non-trial center and transferred to a trial site. An exception: those cannulated for ECMO at another non-trial site location that is part of the same healthcare system and subsequently transferred to a trial site will be eligible
12. Randomization not possible within 36 h following ECMO cannulation (e.g., due to staffing or delays related to communication with participant family
13. ECMO deployed as a bridge to ventricular assist device
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/04/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2025
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Actual
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Sample size
Target
228
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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The Children's Hospital at Westmead - Westmead
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Recruitment postcode(s) [1]
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- Westmead
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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Arkansas
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Country [3]
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United States of America
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State/province [3]
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California
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Country [4]
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United States of America
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State/province [4]
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Colorado
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Country [5]
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United States of America
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State/province [5]
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Georgia
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Country [6]
0
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United States of America
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State/province [6]
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Illinois
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Country [7]
0
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United States of America
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State/province [7]
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Indiana
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Country [8]
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United States of America
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State/province [8]
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Massachusetts
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Country [9]
0
0
United States of America
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State/province [9]
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Michigan
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Country [10]
0
0
United States of America
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State/province [10]
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Ohio
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Country [11]
0
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United States of America
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State/province [11]
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Pennsylvania
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Country [12]
0
0
United States of America
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State/province [12]
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South Carolina
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Country [13]
0
0
United States of America
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State/province [13]
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Tennessee
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Country [14]
0
0
United States of America
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State/province [14]
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Texas
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Country [15]
0
0
United States of America
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State/province [15]
0
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Utah
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Country [16]
0
0
United States of America
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State/province [16]
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Virginia
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Country [17]
0
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United States of America
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State/province [17]
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Washington
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Country [18]
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Canada
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State/province [18]
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Ontario
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Funding & Sponsors
Primary sponsor type
Other
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Name
Boston Children's Hospital
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
TITRE - Trial of Indication-based Transfusion of Red Blood Cells in ECMO, is a multicenter, prospective, randomized clinical trial. The overarching goal of TITRE is to determine whether restricting red blood cell (RBC) transfusion according to an indication-based strategy for those with bleeding and/or deficit of tissue oxygen delivery, compared with transfusion based on center-specific hemoglobin or hematocrit thresholds, can reduce organ dysfunction and improve later neurodevelopment in critically ill children receiving Extracorporeal Membrane Oxygenation (ECMO) support.
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Trial website
https://clinicaltrials.gov/study/NCT05405426
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Lynn A. Sleeper, ScD
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Address
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Boston Children's Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Ravi Thiagarajan, MBBS
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Address
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Country
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Phone
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617-355-4023
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05405426