Contact information
Type
Scientific
Primary contact
Dr Jacques Lacroix
ORCID ID
Contact details
3175 Cote Sainte-Catherine
Montréal
H3T 1C5
Canada
+1 514 7392589 or 3454931ext5556
j_lacroix@videotron.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CIHR-RCT 130770
Study information
Scientific title
Transfusion Requirements in Paediatric Intensive Care Unit: a multicentre randomised controlled non-inferiority clinical trial
Acronym
TRIPICU
Study hypothesis
A restrictive transfusion strategy, using pre-storage leukocyte reduced packed red blood cell units, would not be inferior to a liberal strategy in its effects on multiple organ dysfunction.
Ethics approval
IRB approval was gained from the Comité d'éthique à la recherche for all participating sites prior to participant recruitment.
Study design
Multicentre randomised controlled non-inferiority trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Anaemia
Intervention
Giving more or less red blood cell transfusion.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Number of patients who developed new or progressive multiple organ dysfunction syndrome.
Secondary outcome measures
1. Descriptors of severity of cases of multiple organ dysfunction syndrome (Paediatric Logistic Organ Dysfunction [PELOD] score, maximal number of organ dysfunctions)
2. Mortality (28-day, ICU and hospital mortality rates)
3. Nosocomial infections
4. Length of mechanical ventilation
5. Length of ICU stay and of total hospital stay
6. Adverse events
7. Transfusion reactions
Overall trial start date
26/11/2001
Overall trial end date
28/08/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Stable critically ill children with haemoglobin concentrations below 9.5/dL g within seven days of admission to intensive care unit
2. Aged greater than or equal to 3 days or less than or equal to 14 years old, either sex
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
626
Participant exclusion criteria
1. Post-conception age less than 40 weeks at the time of randomisation
2. Present age less than three days after birth (at term) or less than 14 years old
3. Weight less than 3 kg at the time of randomisation
4. Previous enrolment of a patient in this trial
5. Never discharged home following admission to a neonatalogy intensive care unit
6. Pregnant
7. Post-operative care of a neonatal cardiac surgery who is less than 28 days of age when the surgery occurs
8. Post-operative care of a planned surgery for a cyanotic cardiopathy, unless the cardiopathy was corrected and the patients is older than 28 days of age
9. The patient has an uncorrected cyanotic cardiopathy
10. Haemolytic anaemia (example: sickle cell disease, haemolytic uraemic syndrome)
11. Inability to receive blood for transfusion (e.g. presence of multiple antibodies, Jehovah Witness or other cultural/religious ideology)
12. Hypoxaemia (saturation of oxyhaemoglobin [SpO2] less than or equal to 90% measured using pulse oxymeter) that persists despite a fraction of inspired oxygen (FiO2) of more than or equal to 60% (his criteria will be adopted in the presence of permissive hypoxaemia and of congenital cardiopathy - cyanotic and non-cyanotic)
13. Not considered volume resuscitated by the attending intensivist
14. The blood pressure of the patient is not under control or the patient is not haemodynamically stable
15. Present an acute clinically significant active blood loss at the time of enrolment
16. Severe thrombocytopenia (platelet count less than 20.0 x 10^9/L or 20 000/mm^3)
17. Brain death or suspected brain death
18. Blood exchange-transfusion (manual or automated)
19. Plasmapheresis
20. Haemofiltration, if priming is done with blood
21. Extracorporeal membrane oxygenation (ECMO)
22. Decision taken to withhold or to withdraw critical care
23. Moribund and not expected to survive more than 24 hours (as judged by the attending intensivist)
24. Lack of commitment from the attending staff to continue active treatment of the patient
25. Expected to stay less than 24 hours in the Paediatric Intensive Care Unit (PICU) (as judged by the attending intensivist)
26. Refusal of consent by patient and/or parent
27. Refusal of consent by physician
28. Enrolment in another interventional study that could interfere with the TRIPICU trial
Recruitment start date
26/11/2001
Recruitment end date
28/08/2005
Locations
Countries of recruitment
Belgium, Canada, United Kingdom, United States of America
Trial participating centre
3175 Cote Sainte-Catherine
Montréal
H3T 1C5
Canada
Sponsor information
Organisation
Sainte-Justine Hospital - Research Centre (Canada)
Sponsor details
3175 Côte Sainte-Catherine
Montréal
Québec
H3T 1C5
Canada
+1 514 345 4691
centre@recherche-ste-justine.qc.ca
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 130770)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17442904
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19789443
Publication citations
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Results
Willems A, Harrington K, Lacroix J, Biarent D, Joffe AR, Wensley D, Ducruet T, Hébert PC, Tucci M, , , , Comparison of two red-cell transfusion strategies after pediatric cardiac surgery: a subgroup analysis., Crit. Care Med., 2010, 38, 2, 649-656, doi: 10.1097/CCM.0b013e3181bc816c.
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Lacroix J, Hébert PC, Hutchison JS, Hume HA, Tucci M, Ducruet T, Gauvin F, Collet JP, Toledano BJ, Robillard P, Joffe A, Biarent D, Meert K, Peters MJ, , , , Transfusion strategies for patients in pediatric intensive care units., N. Engl. J. Med., 2007, 356, 16, 1609-1619, doi: 10.1056/NEJMoa066240.