Transfusion Alternatives Pre-Operatively in Sickle Cell Disease

Study point of contact

Charlotte Llewelyn, PhD
01223 548047
[email protected]
Moira Malfroy, BS (Hons),RN
01223 548169
[email protected]

Locations

1 United Kingdom site

Age

> 1 Years

Genotypes

SS

Phase

Phase 3

Study type

Interventional

Gender

All

Interventions

Other

Compensation

Unknown

About the study

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.

participation requirements

– 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.

participation restrictions

– 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).

Locations

  • Cambridge, Cambridgeshire, United Kingdom, NBS/MRC Clinical Studies Unit, National Blood Service, CB2 2PT [Recruiting]