Sickle Cell DiseasePhase 3TAPSNCT00512577
Transfusion Alternatives Pre-operatively in Sickle Cell Disease (TAPS)
A Phase 3 study testing Red blood cell transfusion in people with Sickle Cell Disease, run by NHS Blood and Transplant at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Red blood cell transfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2007to Mar 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 11Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NBS/MRC Clinical Studies Unit, National Blood Service
Cambridge, Cambridgeshire, CB2 2PT
About this study
Official title: 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.
- Conditions
- Sickle Cell Disease
- Being tested
- Red blood cell transfusion
- Keywords
- sickle cell disease, pre-operative transfusion, blood transfusion
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red blood cell transfusionOther
Pre-operative red blood cell transfusion
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Patients will not receive a pre-operative transfusion. Receives: Other: Red blood cell transfusion |
| 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. Receives: Other: Red blood cell transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of all clinically significant complications in sickle Cell patients (Hb SS or SB0 thal) undergoing low or medium risk planned surgery.
Measured: Between randomisation and 30 days post surgery, inclusive.
Secondary outcomes (5)
1. Complications included in the primary outcome, plus red cell alloimmunisation.
Measured: 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.
Measured: Up to 30 days post surgery, inclusive.
3. Re-admission or failure to discharge.
Measured: Up to 30 days post surgery.
Number of red cell units received.
Measured: 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.
Measured: Up to 30 days post surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Study was terminated by Trial Steering Committee.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Blood and Transplant
- Sponsor type
- Other government
- Collaborators
- British Medical Research Council, University of York
- Responsible party
- Sponsor
- Investigators
- Lorna M Williamson, MRCP,MRCPath, Study chair, University of Cambridge and NHSBTSally C Davies, MRCP,MRCPath, Study chair, Imperial College, University of London and Central Middlesex Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512577
- Sponsor's protocol ID
- BS02/4/RB31
- Other IDs
- ISRCTN:00862331
- Acronym
- TAPS
- Status last verified
- Mar 2023
- First submitted
- 6 Aug 2007
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfusion Alternatives Pre-operatively in Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT00512577
- Acronym / sponsor ID
- TAPS / BS02/4/RB31
- Conditions
- Sickle Cell Disease
- Keywords
- sickle cell disease, pre-operative transfusion, blood transfusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated by Trial Steering Committee.
- Enrolment
- 70 participants (actual)
- Lead sponsor
- NHS Blood and TransplantOther government
- Collaborators
- British Medical Research Council, University of York
- Study start
- Jul 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 7 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Other: Red blood cell transfusionPatients will not receive a pre-operative transfusion. |
| B | Active comparator | Other: Red blood cell transfusionPatients 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. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red blood cell transfusionPre-operative red blood cell transfusion | Other | A, B |
Primary outcome
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.
5 secondary outcomes
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.
Results and safety
The study was stopped early (reason given: Study was terminated by Trial Steering Committee.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorna M Williamson, MRCP,MRCPath study chair
University of Cambridge and NHSBT
Sally C Davies, MRCP,MRCPath study chair
Imperial College, University of London and Central Middlesex Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Red blood cell transfusion in people with Sickle Cell Disease, run by NHS Blood and Transplant at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study was terminated by Trial Steering Committee.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.