Transfusion Requirements in Paediatric Intensive Care Unit

ISRCTN	ISRCTN37246456
DOI	https://doi.org/10.1186/ISRCTN37246456
Secondary identifying numbers	CIHR-RCT 130770

Submission date: 27/06/2004
Registration date: 04/07/2005
Last edited: 15/11/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Haematological Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jacques Lacroix
Scientific

3175 Cote Sainte-Catherine
Montréal
H3T 1C5
Canada

Phone	+1 514 7392589 or 3454931ext5556
Email	j_lacroix@videotron.ca

Study information

Study design	Multicentre randomised controlled non-inferiority trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Transfusion Requirements in Paediatric Intensive Care Unit: a multicentre randomised controlled non-inferiority clinical trial
Study acronym	TRIPICU
Study objectives	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(s)	IRB approval was gained from the Comité d'éthique à la recherche for all participating sites prior to participant recruitment.
Health condition(s) or problem(s) studied	Anaemia
Intervention	Giving more or less red blood cell transfusion.
Intervention type	Other
Primary outcome measure	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 study start date	26/11/2001
Completion date	28/08/2005

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	3 Days
Upper age limit	14 Years
Sex	Both
Target number of participants	626
Key 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
Key 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
Date of first enrolment	26/11/2001
Date of final enrolment	28/08/2005

Locations

Countries of recruitment

Belgium
Canada
United Kingdom
United States of America

Study participating centre

3175 Cote Sainte-Catherine

Montréal
H3T 1C5
Canada

Sponsor information

Sainte-Justine Hospital - Research Centre (Canada)
Hospital/treatment centre

3175 Côte Sainte-Catherine
Montréal, Québec
H3T 1C5
Canada

Phone	+1 514 345 4691
Email	centre@recherche-ste-justine.qc.ca
"ROR"	https://ror.org/01gv74p78

Funders

Funder type

Research organisation

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: 130770)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	19/04/2007		Yes	No
Results article	results	01/02/2010		Yes	No