Transfusion Alternatives Pre-operatively in Sickle Cell Disease

NHS Blood and Transplant1 site in 1 country70 target enrollmentJuly 2007

ConditionsSickle Cell Disease

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Sickle Cell Disease
Sponsor: NHS Blood and Transplant
Enrollment: 70
Locations: 1
Primary Endpoint: The frequency of all clinically significant complications in sickle Cell patients (Hb SS or SB0 thal) undergoing low or medium risk planned surgery.
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2007

End Date

March 2011

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

NHS Blood and Transplant

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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 Outcomes

1. Complications included in the primary outcome, plus red cell alloimmunisation.(Up to 3 months post surgery.)
3. Re-admission or failure to discharge.(Up to 30 days 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.)
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.)