Transfusion Alternatives Pre-operatively in Sickle Cell Disease
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 70
- 试验地点
- 1
- 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).
研究组 & 干预措施
A
Patients will not receive a pre-operative transfusion.
干预措施: Red blood cell transfusion (Other)
B
Patients will receive a pre-operative blood transfusion. Those presenting with an admission Hb of less than 9g/dL will receive a simple (also called a 'top-up') transfusion, those presenting with an admission Hb of more than or equal to 9g/dL will undergo a partial exchange transfusion.
干预措施: Red blood cell transfusion (Other)
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
- Number of red cell units received.(Intra and post-operatively.)
- 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.)
- 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.)