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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Pre-operative red blood cell transfusion
NBS/MRC Clinical Studies Unit, National Blood Service
Cambridge, Cambridgeshire, United Kingdom
The frequency of all clinically significant complications in sickle Cell patients (Hb SS or SB0 thal) undergoing low or medium risk planned surgery.
Time frame: Between randomisation and 30 days post surgery, inclusive.
1. Complications included in the primary outcome, plus red cell alloimmunisation.
Time frame: Up to 3 months 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.
Time frame: Up to 30 days post surgery, inclusive.
3. Re-admission or failure to discharge.
Time frame: Up to 30 days post surgery.
Number of red cell units received.
Time frame: 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.
Time frame: Up to 30 days post surgery.
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