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

Sickle Cell Disease Clinical Trial

— TAPS  

Official title:

Transfusion Alternatives Pre-operatively in Sickle Cell Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00512577
• Other study ID #: BS02/4/RB31
• Secondary ID: ISRCTN:00862331
• Status: Terminated
• Phase: Phase 3
• Start date: July 2007
• Est. completion date: March 2011

Study information

• Verified date: March 2023
• Source: NHS Blood and Transplant
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 70
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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).

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Other:
• Red blood cell transfusion
Pre-operative red blood cell transfusion

Locations

Country	Name	City	State
United Kingdom	NBS/MRC Clinical Studies Unit, National Blood Service	Cambridge	Cambridgeshire

Sponsors (3)

Lead Sponsor	Collaborator
NHS Blood and Transplant	British Medical Research Council, University of York

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1. Complications included in the primary outcome, plus red cell alloimmunisation.		Up to 3 months post surgery.
Secondary	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.
Secondary	3. Re-admission or failure to discharge.		Up to 30 days post surgery.
Secondary	Number of red cell units received.		Intra and post-operatively.
Secondary	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.