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

NCT00512577 | Terminated Phase 3 DMC

• 2 other identifiers: BS02/4/RB31ISRCTN:00862331
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Keywords

sickle cell disease; pre-operative transfusion; blood transfusion

Outcome Measures

Primary Outcomes (1)

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

  Between randomisation and 30 days post surgery, inclusive.

Secondary Outcomes (5)

• 1. Complications included in the primary outcome, plus red cell alloimmunisation.

  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.

  Up to 30 days post surgery, inclusive.

• 3. Re-admission or failure to discharge.

  Up to 30 days post surgery.

• Number of red cell units received.

  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.

  Up to 30 days post surgery.

Study Arms (2)

A

ACTIVE COMPARATOR

Patients will not receive a pre-operative transfusion.

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.

Other: Red blood cell transfusion

Interventions

Red blood cell transfusion OTHER

Pre-operative red blood cell transfusion

A; B

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• NHS Blood and Transplant: lead
• British Medical Research Council: collaborator
• University of York: collaborator

Study Sites (1)

NBS/MRC Clinical Studies Unit, National Blood Service

Cambridge, Cambridgeshire, CB2 2PT, United Kingdom

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Erythrocyte Transfusion

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Component Transfusion; Blood Transfusion; Biological Therapy; Therapeutics

Study Officials

• Lorna M Williamson, MRCP,MRCPath

  University of Cambridge and NHSBT

  STUDY CHAIR

• Sally C Davies, MRCP,MRCPath

  Imperial College, University of London and Central Middlesex Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2007
• First Posted: August 7, 2007
• Study Start: July 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 23, 2023

Record last verified: 2023-03

Locations

GB (1)