ISRCTN37246456已完成不适用
Transfusion Requirements in Paediatric Intensive Care Unit: a multicentre randomised controlled non-inferiority clinical trial
Sainte-Justine Hospital - Research Centre (Canada)0 个研究点目标入组 626 人开始时间: 2005年7月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 626
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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