Transfusion Requirements in Paediatric Intensive Care Unit

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 626

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of patients who developed new or progressive multiple organ dysfunction syndrome.

Secondary Outcome Measures

Name	Time	Method
1. Descriptors of severity of cases of multiple organ dysfunction syndrome (Paediatric Logistic Organ Dysfunction [PELOD] score, maximal number of organ dysfunctions)<br>2. Mortality (28-day, ICU and hospital mortality rates)<br>3. Nosocomial infections<br>4. Length of mechanical ventilation<br>5. Length of ICU stay and of total hospital stay<br>6. Adverse events<br>7. Transfusion reactions