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

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ClinicalTrials.gov Identifier: NCT00512577
Recruitment Status : Unknown
Verified August 2007 by NHS Blood and Transplant.
Recruitment status was:  Recruiting
First Posted : August 7, 2007
Last Update Posted : August 14, 2007
British Medical Research Council
University of York
Information provided by:
NHS Blood and Transplant

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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Other: Red cell blood transfusion Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transfusion Alternatives Pre-Operatively in Sickle Cell Disease
Study Start Date : July 2007

Arm Intervention/treatment
Active Comparator: A
Patients will not receive a pre-operative transfusion.
Other: Red cell blood transfusion
Active Comparator: B
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 cell blood transfusion

Primary Outcome Measures :
  1. 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 Measures :
  1. 1. Complications included in the primary outcome, plus red cell alloimmunisation. [ Time Frame: Up to 3 months post surgery. ]
  2. 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. ]
  3. 3. Re-admission or failure to discharge. [ Time Frame: Up to 30 days post surgery. ]
  4. Number of red cell units received. [ Time Frame: Intra and post-operatively. ]
  5. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00512577

Contact: Moira Malfroy, BS (Hons),RN 01223 548169 moira.malfroy@nbs.nhs.uk
Contact: Charlotte Llewelyn, PhD 01223 548047 charlotte.llewelyn@nbs.nhs.uk

United Kingdom
NBS/MRC Clinical Studies Unit, National Blood Service Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 2PT
Sponsors and Collaborators
NHS Blood and Transplant
British Medical Research Council
University of York
Study Chair: 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

ClinicalTrials.gov Identifier: NCT00512577     History of Changes
Other Study ID Numbers: BS02/4/RB31
First Posted: August 7, 2007    Key Record Dates
Last Update Posted: August 14, 2007
Last Verified: August 2007

Keywords provided by NHS Blood and Transplant:
sickle cell disease
pre-operative transfusion
blood transfusion

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn