Pilot Optimizing Transfusion Thresholds in Critically-ill Children With Anaemia
P-OpTTICCA
1 other identifier
interventional
120
1 country
1
Brief Summary
The Pilot Optimizing Transfusion Thresholds in Critically-ill Children with Anaemia (P-OpTTICCA) study is a pilot trial for a large pragmatic international parallel open-label non-inferiority randomised controlled trial. The primary outcome of the pilot study is feasibility.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2020
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2019
CompletedFirst Posted
Study publicly available on registry
March 12, 2019
CompletedStudy Start
First participant enrolled
June 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedSeptember 28, 2021
September 1, 2021
1.6 years
March 6, 2019
September 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Recruitment: screening
Proportion of patients eligible for consent approached \> 90%;
One year
Recruitment: consent
Proportion of approached patients who decline consent \< 20%,
One year
Recruitment: enrolment
Recruitment: ≥ 2 patients randomized/site/week.
One year
Secondary Outcomes (8)
Representativeness: exclusion
One year
Representativeness: opt-out
One year
Compliance
One year
Separation
One year
Suspension
One year
- +3 more secondary outcomes
Study Arms (2)
Restrictive arm (intervention)
EXPERIMENTALLess red blood cell transfusions. The protocol will require that no red blood cell transfusion be given unless the hemoglobin level is below or equal at 70 g per L.
Standard care arm (comparator)
ACTIVE COMPARATORClinical teams will follow their usual transfusion practices.
Interventions
The instructions given to caregivers will be to consider prescribing a red blood cell transfusion only if the hemoglobin level is ≤ 70 g per L.
The instructions given to caregivers will be to prescribe a red blood cell transfusion according to their usual standard practice
Eligibility Criteria
You may qualify if:
- \. Hemoglobin concentration ≤ 95 g/L, while in PICU
- \. Not already participating to a randomized controlled trial on hemoglobin threshold to guide red blood cell transfusion practice
You may not qualify if:
- Post conception age ≤ 36 weeks or \> 18 years at PICU entry
- Refusal of consent by patient and/or parent
- Uncorrected cyanotic cardiac disease, univentricular physiology
- Sickle cell disease
- Brain Death
- Extracorporeal membrane oxygenation (ECMO)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Justine's Hospitallead
- Oxford University Hospitals NHS Trustcollaborator
- Hôpital Jeanne de Flandrecollaborator
- NHS Blood and Transplantcollaborator
Study Sites (1)
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
Related Publications (4)
Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.
PMID: 41114449DERIVEDTucci M, Sarfatti A, Leteurtre S, Du Pont-Thibodeau G, Fontela P, Ray S, Stanworth SJ, Hebert PC, Roumeliotis N, Sauthier M, Spinella PC, Ducruet T, Jouvet P, Masse B, Robitaille N, Trottier H, Lacroix J; Canadian Critical Care Trials Group and the Groupe Francophone de Reanimation et d'Urgences Pediatriques. Pilot-Optimizing Transfusion Therapy in Critically Ill Children With Anemia: A Pilot Multicenter Electronic Health Record-Enabled Randomized Controlled Trial on Red Blood Cell Transfusion in Critically Ill Children. Pediatr Crit Care Med. 2025 Oct 1;26(10):e1218-e1230. doi: 10.1097/PCC.0000000000003822. Epub 2025 Sep 12.
PMID: 40938139DERIVEDRadford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.
PMID: 38780066DERIVEDCarson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
PMID: 34932836DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacques Lacroix
St-Justine Hospital Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 6, 2019
First Posted
March 12, 2019
Study Start
June 3, 2020
Primary Completion
December 31, 2021
Study Completion
December 31, 2022
Last Updated
September 28, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share
The data of P-OpTTICCA will be integrated in the large trial if possible. This will not be possible if P-OpTTICCA shows that significant changes must be made to the research proposal of the full trial; then the data of participants of P-OpTTICCA will be merged to the data of the full trial using a meta-analysis strategy.