Transfusion Alternatives Pre-operatively in Sickle cell disease

ISRCTN	ISRCTN00862331
DOI	https://doi.org/10.1186/ISRCTN00862331
ClinicalTrials.gov number	NCT00512577
Secondary identifying numbers	BS02/4/RB31

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

Study website

Contact information

Dr Lorna Williamson
Scientific

National Blood Service
Long Road
Cambridge
CB2 2PT
United Kingdom

Study information

Study design	A phase III, multicentre, parallel group, group-sequential randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	TAPS
Study objectives	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. 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) studied	Sickle Cell Disease
Intervention	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. As of 17/01/2012, the trial was stopped prematurely because of an excess of SAEs in one or the two arms.
Intervention type	Other
Primary outcome measure	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 measures	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
Overall study start date	05/06/2007
Completion date	05/06/2012
Reason abandoned (if study stopped)	Objectives no longer viable

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
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.
Key inclusion criteria	Current 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 criteria	Current 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 enrolment	05/06/2007
Date of final enrolment	05/06/2012

Locations

Countries of recruitment

Canada
England
Ireland
Netherlands
United Kingdom

Study participating centre

National Blood Service

Cambridge
CB2 2PT
United Kingdom

Sponsor information

NHS Blood and Transplant (NHSBT) (UK)
Government

Professor Marion Scott
Bristol Institute of Transfusion Services
Southmead Road
Bristol
BS10 5ND
United Kingdom

Website	http://www.nhsbt.nhs.uk/
"ROR"	https://ror.org/0227qpa16

Funders

Funder type

Government

The National Blood Service (UK) (ref: BS02/4/RB31) - an operating division of NHS Blood and Transplant: project grant

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan