Condition category
Haematological Disorders
Date applied
27/06/2004
Date assigned
04/07/2005
Last edited
15/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

  2. 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.

Additional files

Editorial Notes