RESCUE-ASDH trial. Version 1.0
Research type
Research Study
Full title
Randomised Evaluation of Surgery with Craniectomy for patients Undergoing Evacuation of Acute Subdural Haematoma (RESCUE-ASDH)
IRAS ID
156623
Contact name
Peter J. A. Hutchinson
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Research summary
It is estimated that 4,000 head-injured patients have emergency brain surgery each year in the NHS. Two-thirds of head-injured patients requiring emergency surgery have a blood clot between the outer lining of the brain and the brain itself. This is called an acute subdural haematoma (ASDH). The pressure this clot puts on the brain can be life threatening, so an urgent operation is needed to remove it. There are two types of operation currently carried out in the NHS:
1. Craniotomy: opening of the skin, removal of a piece of skull, removal of the clot, replacement of the piece of skull, closure of the skin.
2. Decompressive craniectomy (DC): a similar procedure but the piece of skull is left out prior to closing the skin.
The advantage of a DC is that it is more effective in controlling brain swelling which is often a problem in the days after the operation. When the swelling goes down, the patient has another operation (separate admission) to rebuild the skull (with the patient's own bone or an artificial material). The advantage of a craniotomy is that the patient will not need a later operation to rebuild the skull. However, craniotomy may fail to control the brain swelling in some patients. All neurosurgeons are capable of performing both types of operation. Currently, there is no high-quality evidence showing which operation is better. We intend to undertake a randomised trial to provide this much needed evidence. The study design is described below.Lay Summary of Results:
Background It is estimated that 4,000 head-injured patients have emergency brain surgery each year in the UK. Two-thirds of head-injured patients requiring emergency surgery have a blood clot between the outer lining of the brain and the brain itself, known as an acute subdural haematoma (ASDH) and which if not removed can be life threatening. When an ASDH is surgically evacuated, a piece of skull can be left out, known a decompressive craniectomy (DC) or replace prior to closing the skin, known as a craniotomy.Methods
The study allowed us to perform a head-to-head comparison of craniotomy and DC as to whether one is better for the management of ASDH. Following consent, patients were allocated at random to receive either a craniotomy or a DC. Patients unsuitable for inclusion in the study had the operation deemed to be in their best interests by the operation neurosurgeon and all participants were followed up for 1 year to see how well they recovered. To assess value for money, data from UK patients was used to estimate both health and social services costs and Quality Adjusted Life Year (QALY) scores.Results
The analysis of the randomised patients showed no significant difference in the functional outcome (measured using the Glasgow outcome score extended) of the two arms at 12 months, but there were differences in functional outcome between the groups in the observed cohort. However, the patients undergoing the decompressive craniectomy were worse before the operation. UK craniotomy patients were estimated to have both lower costs and have higher QALY scores compared to craniectomy patients.Discussion
The results mean this study showed no significant difference in the overall functional outcome at 12 months of patients who had a decompressive craniectomy versus a craniotomy for the surgical management of an acute subdural haematoma. Craniotomy was estimated to offer better value for money compared to craniectomy with no reductions in activities of daily living.Conclusion
Among patients undergoing evacuation of a traumatic acute subdural haematoma, a decompressive craniectomy did not result in better outcomes than craniotomy and was considered to represent value for money.REC name
North West - Haydock Research Ethics Committee
REC reference
14/NW/1076
Date of REC Opinion
17 Jul 2014
REC opinion
Favourable Opinion