Transfusion Alternatives Pre-operatively in Sickle cell disease

Completed

• Conditions: Sickle Cell Disease; Haematological Disorders; Sickle-cell disorders

• Registration Number: ISRCTN00862331
• Lead Sponsor: HS Blood and Transplant (NHSBT) (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-30
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 400

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified