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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
Scientific title
TITRE: Trial of Indication-Based Transfusion of Red Blood Cells in ECMO
Secondary ID [1] 0 0
W81XWH-22-1-0301
Universal Trial Number (UTN)
Trial acronym
TITRE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extracorporeal Membrane Oxygenation 0 0
Red Blood Cell Transfusion 0 0
Organ Failure, Multiple 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Baseline-adjusted change in pSOFA (pediatric Sequential Organ Failure Assessment) score
Timepoint [1] 0 0
At randomization and at 30 days post-randomization (or up to time of ECMO decannulation if earlier; varies according to patient)
Primary outcome [2] 0 0
Bayley Infant Scales of Development, 4th edition (Bayley-4)
Timepoint [2] 0 0
One year post-randomization (+/- 2 mo)
Primary outcome [3] 0 0
Wechsler Preschool and Primary Scale of Intelligence (WPPSI - IV)
Timepoint [3] 0 0
One year post-randomization (+/-2 mo)
Secondary outcome [1] 0 0
Mixed venous oxygen saturation
Timepoint [1] 0 0
Daily AM (6 AM - 12 AM), during ECMO (up to 30 days post-randomization, whichever is earlier)
Secondary outcome [2] 0 0
Total volume of blood products administered
Timepoint [2] 0 0
30 days post-randomization (or up to time of ECMO decannulation if earlier; varies according to patient)
Secondary outcome [3] 0 0
Presence vs. absence of hospital-acquired Infection
Timepoint [3] 0 0
30 days post-randomization (up to time of ECMO decannulation if earlier; varies according to patient)
Secondary outcome [4] 0 0
Daily renal function
Timepoint [4] 0 0
Daily up to 30 days post-randomization (or up to time of ECMO decannulation if earlier; varies according to patient)
Secondary outcome [5] 0 0
Acute kidney injury > stage 2
Timepoint [5] 0 0
30 days post-randomization (up to time of ECMO decannulation if earlier; varies according to patient)
Secondary outcome [6] 0 0
Number of ECMO circuit component replacements
Timepoint [6] 0 0
At 30 days post-randomization
Secondary outcome [7] 0 0
Presence vs. absence of hemolysis
Timepoint [7] 0 0
Daily up to 30 days post-randomization (or up to time of ECMO decannulation if earlier; varies according to patient)
Secondary outcome [8] 0 0
All-cause mortality
Timepoint [8] 0 0
30 days, in-hospital, and 1 year post-randomization
Secondary outcome [9] 0 0
Discharge location
Timepoint [9] 0 0
At time of hospital discharge (assessed up to 1 year)
Secondary outcome [10] 0 0
Adaptive Behavior Assessment System-3 (ABAS-3)
Timepoint [10] 0 0
1 year post-randomization (+/- 2 mo)
Secondary outcome [11] 0 0
Child Behavior Checklist (CBCL)
Timepoint [11] 0 0
1 year post-randomization (+/- 2 mo)
Secondary outcome [12] 0 0
Pediatric Quality of Life Inventory 4.0 (PedsQL 4.0)
Timepoint [12] 0 0
9 months post-randomization (+/- 1 mo)
Secondary outcome [13] 0 0
Pediatric Quality of Life Inventory Cardiac Module
Timepoint [13] 0 0
9 months post-randomization (+/- 1 mo)
Secondary outcome [14] 0 0
Number of Donor Exposures
Timepoint [14] 0 0
Daily up to 30 days post-randomization (or up to time of ECMO decannulation if earlier; varies according to patient)
Secondary outcome [15] 0 0
Recannulation for ECMO < 48 hours and < 72 hours after decannulation
Timepoint [15] 0 0
From ECMO decannulation hour to 72 hours following ECMO decannulation
Secondary outcome [16] 0 0
ECMO duration
Timepoint [16] 0 0
During Hospitalization: From ECMO cannulation to ECMO decannulation, death, transition to Ventricular Assist Device (VAD) or 365 days post-randomization, whichever is earliest
Secondary outcome [17] 0 0
Duration of mechanical ventilation post-randomization
Timepoint [17] 0 0
During Hospitalization: From Randomization to Extubation from Mechanical Ventilation, death, hospital discharge, or 365 days post-randomization, whichever is earliest
Secondary outcome [18] 0 0
Occurrence of Seizures
Timepoint [18] 0 0
Randomization to Hospital Discharge or 90 days post-randomization, whichever is earliest
Secondary outcome [19] 0 0
Stroke or Intracranial Hemorrhage during ECMO
Timepoint [19] 0 0
Time of ECMO cannulation to ECMO decannulation, death or 30 days post-randomization, whichever occurs first
Secondary outcome [20] 0 0
Stroke or Intracranial Hemorrhage prior to Hospital Discharge
Timepoint [20] 0 0
ECMO cannulation to 90 days post-randomization or hospital discharge, whichever occurs first
Secondary outcome [21] 0 0
Pediatric Overall Performance Category (POPC)
Timepoint [21] 0 0
Randomization to study completion (completion of 12 month neurodevelopment assessment)
Secondary outcome [22] 0 0
Functional Status Score (FSS)
Timepoint [22] 0 0
Randomization to study completion (completion of 12 month neurodevelopment assessment)
Secondary outcome [23] 0 0
ICU Length of Stay among survivors during index hospitalization
Timepoint [23] 0 0
ICU Admission to ICU discharge, death or 365 post-randomization, whichever occurs first
Secondary outcome [24] 0 0
Hospital length of stay among survivors during index hospitalization
Timepoint [24] 0 0
Hospital Admission to discharge death, or 365 days post-randomization, whichever occurs first
Secondary outcome [25] 0 0
Pediatric Cerebral Performance Category (PCPC)
Timepoint [25] 0 0
Randomization to study completion (completion of 12 month neurodevelopment assessment)
Secondary outcome [26] 0 0
Number of ICU admissions prior to discharge from index hospitalization among survivors
Timepoint [26] 0 0
Index ICU discharge to Hospital discharge or 365 days post-randomization, whichever occurs first

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
Minimum age
0 Days
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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 in place or being discussed
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. (note that observational non-interventional studies do not qualify the patient for exclusion)
11. Lack of access to medical records required for calculation of pre-ECMO pSOFA score due to cannulation for ECMO at a non-trial center.
12. Randomization not possible within 36 h following ECMO cannulation (e.g., due to staffing or delays related to communication with participant family)
13. Planned transition to ventricular assist device (VAD) within 48 hours of commencing ECMO.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
228
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Utah
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Other
Name
Boston Children's Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lynn A. Sleeper, ScD
Address 0 0
Boston Children's Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ravi Thiagarajan, MBBS
Address 0 0
Country 0 0
Phone 0 0
617-355-4023
Fax 0 0
Email 0 0
ravi.thiagarajan@cardio.chboston.org
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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