This trial has now closed
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.
- 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.
- 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).
If you require any help, please contact:
Randomisation service provided by: Sealed Envelope.com