To study whether preoperative transfusion increases or decreases the likelihood of having problems after surgery
ID
Source
Brief title
Condition
- Haemoglobinopathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Patients with sickle cell disease (SCD) often have a blood transfusion before
they have surgery. This is done in the belief that it reduces the risk of
having sickle cell related problems after surgery. On the other hand, blood
transfusion itself may carry some risks. In particular, it may decrease the
body's ability to fight the types of infection which sometimes happen after
surgery eg chest or wound infections. Not all patients receive a blood
transfusion before surgery however, and some reports suggest that these
patients do equally well. Unfortunately there haven t been many studies looking
into this, so it isn t really known if blood transfusion helps or not. We are
carrying out a study, known as a randomised controlled trial (RCT), to find out
whether there is really a need to give blood transfusions before surgery to
people with SCD. Patients will be randomly put into two equal groups before
planned surgery; one group will have a transfusion and the other group will
not. . Approximately 400 patients will be needed to take part in the study in
order to discover which is the best treatment for sickle cell patients before
surgery.
Study objective
To study whether preoperative transfusion increases or decreases the likelihood
of having problems after surgery
Study design
A multicentre, pragmatic, parallel group, group sequential (3), randomised
controlled trial. Because of the nature of the intervention, the trial will not
be blinded.
Intervention
Pre-operative transfusion.
Study burden and risks
not applicable
Bristol
BS10 5ND
GB
Bristol
BS10 5ND
GB
Listed location countries
Age
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
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 <6.5g/dL (4 mmol/l).
6. Children with a clinical history of stroke (history of silent infarcts would not
preclude randomisation).
7. Acute chest syndrome within the last 6 months, or patient has ever required
intubation and mechanical ventilation for treatment of acute chest syndrome.
8. 0xygen saturation at randomisation <90%.
9. Patient is on renal dialysis.
10. Already entered twice into the TAPS trial.
11. The physician is unwilling to randomise the patient (such patients will be
entered into a trial log).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ISRCTN | ISRCTNNumber:00862331 |
| CCMO | NL28295.018.09 |