Sickle Cell Disease Haematological Disorders Sickle-cell disorders
Conditions
Interventions
Patients will be randomised to one of two arms:
Arm A will not receive a pre-operative blood transfusion.
Arm B will receive a pre-operative blood transfusion (top-up or exchange depending on Hb leve
Sponsors
NHS Blood and Transplant (NHSBT) (UK)
Eligibility
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 12/01/2012 1. Patient is one year of age or more 2. Sickle cell disease, either Hb SS or Hb SB thal, confirmed by Hb electrophoresis, deoxyribonucleic acid (DNA) analysis or high performance liquid chromatography (HPLC) 3. At least 24 hours and no more than 28 days before surgery and a date for surgery has been given 4. Surgery to be low or medium risk 5. Surgery to be with general or regional anaesthesia 6. Written informed consent from patient/parent/guardian is given 7. More than six months since previous TAPS trial surgery Previous inclusion criteria 1. Patient is one year of age or more 2. Sickle cell disease, either Hb SS or Hb SB thal, confirmed by Hb electrophoresis, deoxyribonucleic acid (DNA) analysis or high performance liquid chromatography (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 5. Surgery to be with general or regional anaesthesia 6. Written informed consent from patient/parent/guardian is given 7. More than six months since previous TAPS trial surgery
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 12/01/2012 1. Having a procedure involving intravascular contrast radiography or an imaging procedure 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 less than 6.5 g/dL 6. Children with a clinical history of stroke (history of silent infarcts would not preclude randomisation) 7. Acute chest syndrome within the last six months, or patient has ever required intubation and mechanical ventilation for treatment of acute chest syndrome which is still relevant to their condition. 8. Oxygen saturation at randomisation less than 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) Previous exclusion criteria 1. Having a procedure involving intravascular contrast radiography or an imaging procedure 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 less than 6.5 g/dL 6. Children with a clinical history of stroke (history of silent infarcts would not preclude randomisation) 7. Acute chest syndrome within the last six months, or patient has ever required intubation and mechanical ventilation for treatment of acute chest syndrome 8. Oxygen saturation at randomisation less than 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The frequency of all clinically significant complications in sickle cell patients (Hb SS or SB thal) undergoing low or medium risk planned surgery between day of randomisation and 30 days post surgery, inclusive. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complications included in the primary outcome, plus red cell alloimmunisation at three months post surgery 2. Total days in hospital up to 30 days post surgery, to include hours/days spent having pre-operative transfusion, days on intensive care and high dependency units, and other wards 3. Re-admission or failure to discharge within 30 days post surgery 4. Number of red cell units received (intra and post-operatively) 5. Health Economic Analysis incorporating the following elements: 5.1. Differential health service costs of routine transfusion relative to control 5.2. Differential benefits of routine transfusion in terms of quality adjusted survival 5.3. The cost-effectiveness of the two forms of management based on differential costs 5.4. Benefits and quality-adjusted life years | — |
Countries
Canada, Ireland, Netherlands, United Kingdom
Outcome results
None listed