Transfusion Alternatives Pre-operatively in Sickle cell disease

ISRCTN ISRCTN00862331
DOI https://doi.org/10.1186/ISRCTN00862331
ClinicalTrials.gov (NCT) NCT00512577
Protocol serial number BS02/4/RB31
Sponsor NHS Blood and Transplant (NHSBT) (UK)
Funder The National Blood Service (UK) (ref: BS02/4/RB31) - an operating division of NHS Blood and Transplant: project grant
Submission date
23/05/2007
Registration date
30/05/2007
Last edited
18/04/2012
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

http://www.ctu.mrc.ac.uk/research_areas/study_details.aspx?s=36

Contact information

Dr Lorna Williamson
Scientific

National Blood Service
Long Road
Cambridge
CB2 2PT
United Kingdom

Study information

Primary study designInterventional
Study designA phase III, multicentre, parallel group, group-sequential randomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study acronymTAPS
Study objectivesThe 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.

Amended as of 12/01/2012
Countries of recruitment: USA was deleted and Netherlands, Canada and Ireland were added.
Ethics approval(s)London Multicentre Research Ethics Committee on 04/12/2006 (ref: 06/MRE02/43).
Health condition(s) or problem(s) studiedSickle Cell Disease
InterventionPatients 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.

As of 17/01/2012, the trial was stopped prematurely because of an excess of SAEs in one or the two arms.
Intervention typeOther
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.

Key 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

Completion date05/06/2012
Reason abandoned (if study stopped)Objectives no longer viable

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target sample size at registration400
Key inclusion criteriaCurrent inclusion criteria as of 12/01/2012
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 28 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

Previous 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
Key exclusion criteriaCurrent exclusion criteria as of 12/01/2012
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 which is still relevant to their condition.
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)

Previous 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)
Date of first enrolment05/06/2007
Date of final enrolment05/06/2012

Locations

Countries of recruitment

  • United Kingdom
  • England
  • Canada
  • Ireland
  • Netherlands

Study participating centre

National Blood Service
Cambridge
CB2 2PT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Study website Study website 11/11/2025 11/11/2025 No Yes
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