Sickle Cell Disease
Conditions
Keywords
sickle cell disease, pre-operative transfusion, blood transfusion
Brief summary
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.
Interventions
OTHERRed blood cell transfusion
Pre-operative red blood cell transfusion
Sponsors
British Medical Research Council
University of York
NHS Blood and Transplant
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The frequency of all clinically significant complications in sickle Cell patients (Hb SS or SB0 thal) undergoing low or medium risk planned surgery. | Between randomisation and 30 days post surgery, inclusive. |
Secondary
| Measure | Time frame |
|---|---|
| 1. Complications included in the primary outcome, plus red cell alloimmunisation. | 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. | Up to 30 days post surgery, inclusive. |
| 3. Re-admission or failure to discharge. | Up to 30 days post surgery. |
| Number of red cell units received. | 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. | Up to 30 days post surgery. |
Countries
United Kingdom
Outcome results
None listed