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A multi-centre, randomised controlled trial of pre-operative blood transfusion for patients with sickle cell disease undergoing surgery. Patients will be recruited from both Europe and North America and randomised to either pre-operative blood transfusion or no pre-operative blood transfusion. The target sample size is 400 over 5 years.

Inclusion Criteria

• Patient is one year of age or more
• Sickle cell disease, either HbSS or HbSβ⁰thal, confirmed by Hb electropheresis, DNA analysis or HPLC
• At least 24 hours 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 6 months since previous TAPS trial surgery. Patient can be entered and randomised up to a maximum of twice if the surgical procedures are at least 6 month apart.

Patient Exclusions

• 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 <6.5 g/dL
• Children with a clinical history of stroke (history of silent infarcts would not preclude randomisation)
• Acute chest syndrome within last 6 months, or patient has ever required intubation and mechanical ventilation for treatment of acute chest syndrome
• Oxygen saturation at randomisation <90%
• Patient is on renal dialysis
• Already entered twice into TAPS trial
• The physician is unwilling to randomise

History of sickle cell complications

History of sickle cell complications is defined as:

• Patients who have attended a health care facility and been administered opioid analgesia more than 3 times in the previous 12 months
• An adult with a past history of stroke
• 0₂ sats at 90-94% inclusive in steady state
• Previously diagnosed pulmonary hypertension
• Renal impairment with a baseline creatinine >100μmol/L (1.2mg/dL)

If a patient scores 'YES' to ANY of the above, they will be regarded as having sickle cell complication(s).

ISRCTN 00862331

If you require any help, please contact: Moira Malfroy Email: moira.malfroy@nbs.nhs.uk

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