ISRCTN00862331已完成不适用
Transfusion Alternatives Pre-operatively in Sickle cell disease
HS Blood and Transplant (NHSBT) (UK)0 个研究点目标入组 400 人开始时间: 2007年5月30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
- 400
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
入选标准
- •Current inclusion criteria as of 12/01/2012
- •1. Patient is one year of age or more
- •2. Sickle cell disease, either Hb SS or Hb SB thal, confirmed by Hb electrophoresis, deoxyribonucleic acid (DNA) analysis or high performance liquid chromatography (HPLC)
- •3. At least 24 hours and no more than 28 days before surgery and a date for surgery has been given
- •4. Surgery to be low or medium risk
- •5. Surgery to be with general or regional anaesthesia
- •6. Written informed consent from patient/parent/guardian is given
- •7. More than six months since previous TAPS trial surgery
- •Previous inclusion criteria
- •1. Patient is one year of age or more
- •2. Sickle cell disease, either Hb SS or Hb SB thal, confirmed by Hb electrophoresis, deoxyribonucleic acid (DNA) analysis or high performance liquid chromatography (HPLC)
- •3. At least 24 hours and no more than 14 days before surgery and a date for surgery has been given
- •4. Surgery to be low or medium risk
- •5. Surgery to be with general or regional anaesthesia
- •6. Written informed consent from patient/parent/guardian is given
- •7. More than six months since previous TAPS trial surgery
排除标准
- •Current exclusion criteria as of 12/01/2012
- •1. Having a procedure involving intravascular contrast radiography or an imaging procedure
- •2. On a regular blood transfusion regime
- •3. Had a blood transfusion within the last three months
- •4. The planned procedure involves local anaesthetic only
- •5. Haemoglobin level at randomisation less than 6.5 g/dL
- •6. Children with a clinical history of stroke (history of silent infarcts would not preclude randomisation)
- •7. Acute chest syndrome within the last six months, or patient has ever required intubation and mechanical ventilation for treatment of acute chest syndrome which is still relevant to their condition.
- •8. Oxygen saturation at randomisation less than 90%
- •9. Patient is on renal dialysis
- •10. Already entered twice into the TAPS trial
- •11. The physician is unwilling to randomise the patient (such patients will be entered into a trial log)
- •Previous exclusion criteria
- •1. Having a procedure involving intravascular contrast radiography or an imaging procedure
- •2. On a regular blood transfusion regime
- •3. Had a blood transfusion within the last three months
- •4. The planned procedure involves local anaesthetic only
- •5. Haemoglobin level at randomisation less than 6.5 g/dL
- •6. Children with a clinical history of stroke (history of silent infarcts would not preclude randomisation)
- •7. Acute chest syndrome within the last six months, or patient has ever required intubation and mechanical ventilation for treatment of acute chest syndrome
- •8. Oxygen saturation at randomisation less than 90%
- •9. Patient is on renal dialysis
- •10. Already entered twice into the TAPS trial
- •11. The physician is unwilling to randomise the patient (such patients will be entered into a trial log)
研究者
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