Transfusion Alternatives Pre-operatively in Sickle Cell Disease (TAPS)

NHS Blood and Transplant

Status and phase: Terminated; Phase 3

Conditions: Sickle Cell Disease

Treatments: Other: Red blood cell transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00512577

ISRCTN:00862331

BS02/4/RB31

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

A

Active Comparator group

Description:

Patients will not receive a pre-operative transfusion.

Treatment:

Other: Red blood cell transfusion

B

Active Comparator group

Description:

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.

Treatment:

Other: Red blood cell transfusion