NCT00512577终止3 期
Transfusion Alternatives Pre-operatively in Sickle Cell Disease
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- The frequency of all clinically significant complications in sickle Cell patients (Hb SS or SB0 thal) undergoing low or medium risk planned surgery.
研究概览
简要总结
TAPS is a sequential trial which aims to investigate whether the administration of a blood transfusion pre-operatively to patients with sickle cell disease (HB SS or Hb SB0 thal)having low or medium risk elective surgery increases or decreases the overall rate of peri-operative complications. The proportion of patients with peri-operative complications in two randomised groups of transfused and untransfused patients will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sickle cell disease, either Hb SS or Hb SB0 thal, confirmed by Hb electrophoresis, Deoxyribonucleic Acid (DNA) analysis or High Performance Liquid Chromatography (HPLC)
- •At least 24 hourse and no more than 14 days before surgery and a date for surgery has been given
- •Surgery to be low or medium risk
- •Surgery to be with general or regional anaesthesia
- •Written informed consent from patient/parent/guardian is given
- •More than six months since previous TAPS trial surgery.
排除标准
- •Having a procedure involving intravascular contrast radiography or an imaging procedure
- •On a regular blood transfusion regime
- •Had a blood transfusion within the last three months
- •The planned procedure involves local anaesthetic only
- •Haemoglobin level at randomisation less than 6.5g/dL
- •Children with a clinical history of stroke (history of silent infarcts would not preclude randomisation)
- •Acute chest syndrome within the last six months, or patient has ever required intubation and mechanical ventilation for treatment of acute chest syndrome
- •Oxygen saturation at randomisation less than 90%
- •Patient is on renal dialysis
- •Already entered twice into the TAPS trial
- •The physician is unwilling to randomise the patient (such patients will be entered into a trial log).
结局指标
主要结局
The frequency of all clinically significant complications in sickle Cell patients (Hb SS or SB0 thal) undergoing low or medium risk planned surgery.
时间窗: Between randomisation and 30 days post surgery, inclusive.
次要结局
- 1. Complications included in the primary outcome, plus red cell alloimmunisation.(Up to 3 months post surgery.)
- 3. Re-admission or failure to discharge.(Up to 30 days post surgery.)
- 2. Total days in hospital, to include hours/days spent having pre-operative transfusion, days on intensive care and high dependency units, and other wards.(Up to 30 days post surgery, inclusive.)
- Number of red cell units received.(Intra and post-operatively.)
- Health economic analysis: differential health service costs of routine transfusion relative to control, plus quality adjusted survival and treatment cost-effectiveness and benefits in QOL years.(Up to 30 days post surgery.)
研究者
研究点 (2)
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