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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN:00862331 |
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Study was terminated by Trial Steering Committee.
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| Name | Class |
|---|---|
| British Medical Research Council | OTHER_GOV |
| University of York | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Patients will not receive a pre-operative transfusion. |
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| B | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Red blood cell transfusion | Other | Pre-operative red blood cell transfusion |
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| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lorna M Williamson, MRCP,MRCPath | University of Cambridge and NHSBT | Study Chair |
| Sally C Davies, MRCP,MRCPath | Imperial College, University of London and Central Middlesex Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NBS/MRC Clinical Studies Unit, National Blood Service | Cambridge | Cambridgeshire | CB2 2PT | United Kingdom |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D017707 | Erythrocyte Transfusion |
| ID | Term |
|---|---|
| D016913 | Blood Component Transfusion |
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| 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. |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |