Transfusion Alternatives Pre-operatively in Sickle Cell Disease (TAPS study) Randomised Controlled Trial - TAPS study

HS BLood Transplant, Bristol Institute for Transfusion Services0 个研究点目标入组 50 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•Patient inclusion criteria;1. Patient is one year of age or older
•2. Sickle cell disease, either HbSS or HbSBeta0-thal, confirmed by Hb electropheresis,
•DNA analysis or 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 (see below and Appendix F)*
•5. Surgery to be with general or regional anaesthesia.
•6. Written informed consent from patient/parent/guardian is given
•7. More than 6 months since previous TAPS trial surgery**

•1. Having a procedure involving intravascular contrast radiography or an imaging
•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 <6.5g/dL (4 mmol/l).
•6. Children with a clinical history of stroke (history of silent infarcts would not
•preclude randomisation).
•7. Acute chest syndrome within the last 6 months, or patient has ever required
•intubation and mechanical ventilation for treatment of acute chest syndrome.
•8. 0xygen saturation at randomisation <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).

发起方

HS BLood Transplant, Bristol Institute for Transfusion Services