Clinical trial NCT00512577: Transfusion Alternatives Pre-operatively in Sickle Cell Disease (TAPS)
Official title: Transfusion Alternatives Pre-operatively in Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Sickle Cell Disease
Keywords: sickle cell disease
pre-operative transfusion
blood transfusion
Lead sponsor: NHS Blood and Transplant
Sponsor class: OTHER_GOV
Collaborators: name: British Medical Research Council
name: University of York
First posted: 2007-08-07
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: The frequency of all clinically significant complications in sickle Cell patients (Hb SS or SB0 thal) undergoing low or medium risk planned surgery.
timeFrame: Between randomisation and 30 days post surgery, inclusive.
Secondary outcomes:
measure: 1. Complications included in the primary outcome, plus red cell alloimmunisation.
timeFrame: Up to 3 months post surgery.
measure: 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.
timeFrame: Up to 30 days post surgery, inclusive.
measure: 3. Re-admission or failure to discharge.
timeFrame: Up to 30 days post surgery.
measure: Number of red cell units received.
timeFrame: Intra and post-operatively.
measure: 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.
timeFrame: Up to 30 days post surgery.
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: NBS/MRC Clinical Studies Unit, National Blood Service
state: Cambridgeshire
Study officials:
affiliation: University of Cambridge and NHSBT
name: Lorna M Williamson, MRCP,MRCPath
role: STUDY_CHAIR
affiliation: Imperial College, University of London and Central Middlesex Hospital
name: Sally C Davies, MRCP,MRCPath
role: STUDY_CHAIR
References: