Condition category
Haematological Disorders
Date applied
23/05/2007
Date assigned
30/05/2007
Last edited
18/04/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Contact information

Type

Scientific

Primary contact

Dr Lorna Williamson

ORCID ID

Contact details

National Blood Service
Long Road
Cambridge
CB2 2PT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00512577

Protocol/serial number

BS02/4/RB31

Study information

Scientific title

Acronym

TAPS

Study hypothesis

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

London Multicentre Research Ethics Committee on 04/12/2006 (ref: 06/MRE02/43).

Study design

A phase III, multicentre, parallel group, group-sequential randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Phase III

Drug names

Primary outcome measures

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 trial start date

05/06/2007

Overall trial end date

05/06/2012

Reason abandoned

Objectives no longer viable

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

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.

Participant 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)

Recruitment start date

05/06/2007

Recruitment end date

05/06/2012

Locations

Countries of recruitment

Canada, Ireland, Netherlands, United Kingdom

Trial participating centre

National Blood Service
Cambridge
CB2 2PT
United Kingdom

Sponsor information

Organisation

NHS Blood and Transplant (NHSBT) (UK)

Sponsor details

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

Sponsor type

Government

Website

http://www.nhsbt.nhs.uk/

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes