sickle cell anemia sickle cell disease
Conditions
Interventions
Pre-operative transfusion.
Sponsors
NHS BLood Transplant, Bristol Institute for Transfusion Services
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patient inclusion criteria;1. Patient is one year of age or older 2. Sickle cell disease, either HbSS or HbSBeta0-thal, confirmed by Hb electropheresis, DNA analysis or HPLC. 3. At least 24 hours and no more than 14 days before surgery and a date for surgery has been given. 4. Surgery to be Low or Medium Risk (see below and Appendix F)* 5. Surgery to be with general or regional anaesthesia. 6. Written informed consent from patient/parent/guardian is given 7. More than 6 months since previous TAPS trial surgery**
Exclusion criteria
Exclusion criteria: 1. Having a procedure involving intravascular contrast radiography or an imaging procedure. 2. On a regular blood transfusion regime. 3. Had a blood transfusion within the last three months. 4. The planned procedure involves local anaesthetic only. 5. Haemoglobin level at randomisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the frequency of all clinically significant complications (sickle related, transfusion related, surgical and infections) between the day of randomisation and up to and including 30 days post surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures will include: complications included in the primary outcome plus red cell alloimmunisation at 3 months, total hospital days including ICU (pre, intra and post-operative), number of red cell units received intra and post-operatively, readmission or failure to discharge up to and including the 30th day following surgery. | — |
Countries
Netherlands
Outcome results
None listed