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

Study Overview
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Brief Summary
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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.

Official Title
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Transfusion Alternatives Pre-operatively in Sickle Cell Disease

Conditions
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Sickle Cell Disease

Intervention / Treatment
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* Other: Red blood cell transfusion


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Patients will not receive a pre-operative transfusion. | Other: Red blood cell transfusion<br>* Pre-operative red blood cell transfusion<br>|
| Active Comparator: B<br>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. | Other: Red blood cell transfusion<br>* Pre-operative red blood cell transfusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sickle cell disease, pre-operative transfusion, blood transfusion