- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00512577
Transfusion Alternatives Pre-operatively in Sickle Cell Disease (TAPS) (TAPS)
March 21, 2023 updated by: NHS Blood and Transplant
Transfusion Alternatives Pre-operatively in Sickle Cell Disease
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Moira Malfroy, BS (Hons),RN
- Phone Number: 01223 548169
- Email: moira.malfroy@nbs.nhs.uk
Study Contact Backup
- Name: Charlotte Llewelyn, PhD
- Phone Number: 01223 548047
- Email: charlotte.llewelyn@nbs.nhs.uk
Study Locations
-
-
Cambridgeshire
-
Cambridge, Cambridgeshire, United Kingdom, CB2 2PT
- NBS/MRC Clinical Studies Unit, National Blood Service
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: A
Patients will not receive a pre-operative transfusion.
|
Pre-operative red blood cell 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.
|
Pre-operative red blood cell transfusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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.
Time Frame: Between randomisation and 30 days post surgery, inclusive.
|
Between randomisation and 30 days post surgery, inclusive.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
1. Complications included in the primary outcome, plus red cell alloimmunisation.
Time Frame: Up to 3 months post surgery.
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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.
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Up to 30 days post surgery, inclusive.
|
3. Re-admission or failure to discharge.
Time Frame: Up to 30 days post surgery.
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Up to 30 days post surgery.
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Number of red cell units received.
Time Frame: Intra and post-operatively.
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Intra and post-operatively.
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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.
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Up to 30 days post surgery.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
August 6, 2007
First Submitted That Met QC Criteria
August 6, 2007
First Posted (Estimate)
August 7, 2007
Study Record Updates
Last Update Posted (Actual)
March 23, 2023
Last Update Submitted That Met QC Criteria
March 21, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BS02/4/RB31
- ISRCTN:00862331
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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