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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by NHS Blood and Transplant.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
British Medical Research Council
University of York
Information provided by:
NHS Blood and Transplant
ClinicalTrials.gov Identifier:
NCT00512577
First received: August 6, 2007
Last updated: August 13, 2007
Last verified: August 2007
  Purpose

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 Intervention Phase
Sickle Cell Disease
Other: Red cell blood transfusion
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transfusion Alternatives Pre-Operatively in Sickle Cell Disease

Resource links provided by NLM:


Further study details as provided by NHS Blood and Transplant:

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. [ Time Frame: Between randomisation and 30 days post surgery, inclusive. ]

Secondary Outcome Measures:
  • 1. Complications included in the primary outcome, plus red cell alloimmunisation. [ Time Frame: 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. [ Time Frame: Up to 30 days post surgery, inclusive. ]
  • 3. Re-admission or failure to discharge. [ Time Frame: Up to 30 days post surgery. ]
  • Number of red cell units received. [ Time Frame: 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. [ Time Frame: Up to 30 days post surgery. ]

Estimated Enrollment: 400
Study Start Date: July 2007
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00512577

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

Locations
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
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00512577     History of Changes
Other Study ID Numbers: BS02/4/RB31, ISRCTN:00862331
Study First Received: August 6, 2007
Last Updated: August 13, 2007
Health Authority: United Kingdom: Research Ethics Committee

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
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 11, 2014