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02 September 2010
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| [ Print-friendly version ] |
| Transfusion Alternatives Pre-operatively in Sickle cell disease |
| ISRCTN | ISRCTN00862331 |
| ClinicalTrials.gov identifier | NCT00512577 |
| Public title | Transfusion Alternatives Pre-operatively in Sickle cell disease |
| Scientific title | |
| Acronym | TAPS |
| Serial number at source | BS02/4/RB31 |
| Study hypothesis | The trial aims to investigate whether the administration of a blood transfusion preoperatively to patients with sickle cell disease (Hb SS or Hb SB thal) increases or decreases the overall rate of peri-operative complications. The proportions of patients with peri-operative complications in two randomised groups of transfused and untransfused patients will be compared. |
| Ethics approval | Approval received from the London Multicentre Research Ethics Committee on the 4th December 2006 (ref: 06/MRE02/43). |
| Study design | A phase III, multicentre, parallel group, group-sequential randomised controlled trial |
| Countries of recruitment | United Kingdom, United States of America |
| Disease/condition/study domain | Sickle Cell Disease |
| Participants - 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 |
| Participants - 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) |
| Anticipated start date | 05/06/2007 |
| Anticipated end date | 05/06/2012 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | As this is a sequential trial the exact number cannot be anticipated but it is predicted that approximately 400 patients will be recruited to the study. |
| Interventions |
Patients will be randomised to one of two arms:
Arm A will not receive a pre-operative blood transfusion. Arm B will receive a pre-operative blood transfusion (top-up or exchange depending on Hb level). The follow-up period is 30 days post surgery with a blood sample taken additionally at three months post surgery. |
| Primary outcome measure(s) | The frequency of all clinically significant complications in sickle cell patients (Hb SS or SB thal) undergoing low or medium risk planned surgery between day of randomisation and 30 days post surgery, inclusive. |
| Secondary outcome measure(s) |
1. Complications included in the primary outcome, plus red cell alloimmunisation at three months post surgery
2. Total days in hospital up to 30 days post surgery, to include hours/days spent having pre-operative transfusion, days on intensive care and high dependency units, and other wards 3. Re-admission or failure to discharge within 30 days post surgery 4. Number of red cell units received (intra and post-operatively) 5. Health Economic Analysis incorporating the following elements: 5.1. Differential health service costs of routine transfusion relative to control 5.2. Differential benefits of routine transfusion in terms of quality adjusted survival 5.3. The cost-effectiveness of the two forms of management based on differential costs 5.4. Benefits and quality-adjusted life years |
| Sources of funding | The National Blood Service (UK) (ref: BS02/4/RB31) - an operating division of NHS Blood and Transplant: project grant |
| Trial website | http://www.ctu.mrc.ac.uk/studies/taps.asp |
| Publications | |
| Contact name | Dr Lorna Williamson |
| Address |
National Blood Service
Long Road |
| City/town | Cambridge |
| Zip/Postcode | CB2 2PT |
| Country | United Kingdom |
| Sponsor | NHS Blood and Transplant (NHSBT) (UK) |
| Address |
Professor Marion Scott
Bristol Institute of Transfusion Services Southmead Road |
| City/town | Bristol |
| Zip/Postcode | BS10 5ND |
| Country | United Kingdom |
| Sponsor website: | http://www.nhsbt.nhs.uk/ |
| Date applied | 23/05/2007 |
| Last edited | 16/09/2008 |
| Date ISRCTN assigned | 30/05/2007 |
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