Title
Transfusion Alternatives Pre-operatively in Sickle Cell Disease (TAPS)
Transfusion Alternatives Pre-operatively in Sickle Cell Disease
Phase
Phase 3Lead Sponsor
NHS Blood and TransplantStudy Type
InterventionalStatus
TerminatedIndication/Condition
Sickle Cell DiseaseIntervention/Treatment
Red blood cell transfusionStudy Participants
70TAPS 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.
Pre-operative red blood cell transfusion
Patients will not receive a pre-operative transfusion.
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.
Inclusion Criteria: 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. Exclusion Criteria: 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).
