search
Back to results

Transfusion Alternatives Pre-operatively in Sickle Cell Disease (TAPS) (TAPS)

Primary Purpose

Sickle Cell Disease

Status
Terminated
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Red blood cell transfusion
Sponsored by
NHS Blood and Transplant
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Disease focused on measuring sickle cell disease, pre-operative transfusion, blood transfusion

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • NBS/MRC Clinical Studies Unit, National Blood Service

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

Patients will not receive a pre-operative transfusion.

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.

Outcomes

Primary Outcome Measures

The frequency of all clinically significant complications in sickle Cell patients (Hb SS or SB0 thal) undergoing low or medium risk planned surgery.

Secondary Outcome Measures

1. Complications included in the primary outcome, plus red cell alloimmunisation.
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.
3. Re-admission or failure to discharge.
Number of red cell units received.
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.

Full Information

First Posted
August 6, 2007
Last Updated
March 21, 2023
Sponsor
NHS Blood and Transplant
Collaborators
British Medical Research Council, University of York
search

1. Study Identification

Unique Protocol Identification Number
NCT00512577
Brief Title
Transfusion Alternatives Pre-operatively in Sickle Cell Disease (TAPS)
Acronym
TAPS
Official Title
Transfusion Alternatives Pre-operatively in Sickle Cell Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated by Trial Steering Committee.
Study Start Date
July 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NHS Blood and Transplant
Collaborators
British Medical Research Council, University of York

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. The proportion of patients with peri-operative complications in two randomised groups of transfused and untransfused patients will be compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
sickle cell disease, pre-operative transfusion, blood transfusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Patients will not receive a pre-operative transfusion.
Arm Title
B
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Red blood cell transfusion
Intervention Description
Pre-operative red blood cell transfusion
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
1. Complications included in the primary outcome, plus red cell alloimmunisation.
Time Frame
Up to 3 months post surgery.
Title
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.
Title
3. Re-admission or failure to discharge.
Time Frame
Up to 30 days post surgery.
Title
Number of red cell units received.
Time Frame
Intra and post-operatively.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorna M Williamson, MRCP,MRCPath
Organizational Affiliation
University of Cambridge and NHSBT
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sally C Davies, MRCP,MRCPath
Organizational Affiliation
Imperial College, University of London and Central Middlesex Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
NBS/MRC Clinical Studies Unit, National Blood Service
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB2 2PT
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Transfusion Alternatives Pre-operatively in Sickle Cell Disease (TAPS)

We'll reach out to this number within 24 hrs