Transfusion Alternatives Pre-Operatively in Sickle Cell Disease (TAPS)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by NHS Blood and Transplant.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
NHS Blood and Transplant
Collaborators:
British Medical Research Council
University of York
Information provided by:
NHS Blood and Transplant
ClinicalTrials.gov Identifier:
NCT00512577
First received: August 6, 2007
Last updated: August 13, 2007
Last verified: August 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Sickle Cell Disease |
Other: Red cell blood transfusion |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Transfusion Alternatives Pre-Operatively in Sickle Cell Disease |
Resource links provided by NLM:
Further study details as provided by NHS Blood and Transplant:
Primary Outcome Measures:
- The frequency of all clinically significant complications in sickle Cell patients (Hb SS or SB0 thal) undergoing low or medium risk planned surgery. [ Time Frame: Between randomisation and 30 days post surgery, inclusive. ]
Secondary Outcome Measures:
- 1. Complications included in the primary outcome, plus red cell alloimmunisation. [ Time Frame: 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. [ Time Frame: Up to 30 days post surgery, inclusive. ]
- 3. Re-admission or failure to discharge. [ Time Frame: Up to 30 days post surgery. ]
- Number of red cell units received. [ Time Frame: 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. [ Time Frame: Up to 30 days post surgery. ]
| Estimated Enrollment: | 400 |
| Study Start Date: | July 2007 |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Patients will not receive a pre-operative transfusion.
|
Other: Red cell blood transfusion |
|
Active Comparator: B
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 cell blood transfusion |
Eligibility| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00512577
Contacts
| Contact: Moira Malfroy, BS (Hons),RN | 01223 548169 | moira.malfroy@nbs.nhs.uk |
| Contact: Charlotte Llewelyn, PhD | 01223 548047 | charlotte.llewelyn@nbs.nhs.uk |
Locations
| United Kingdom | |
| NBS/MRC Clinical Studies Unit, National Blood Service | Recruiting |
| Cambridge, Cambridgeshire, United Kingdom, CB2 2PT | |
Sponsors and Collaborators
NHS Blood and Transplant
British Medical Research Council
University of York
Investigators
| Study Chair: | 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00512577 History of Changes |
| Other Study ID Numbers: | BS02/4/RB31, ISRCTN:00862331 |
| Study First Received: | August 6, 2007 |
| Last Updated: | August 13, 2007 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by NHS Blood and Transplant:
|
sickle cell disease pre-operative transfusion blood transfusion |
Additional relevant MeSH terms:
|
Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia |
Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on May 23, 2013