RESCUE-ASDH trial. Version 2.0
Research type
Research Study
Full title
Randomised Evaluation of Surgery with Craniectomy for patients Undergoing Evacuation of Acute Subdural Haematoma (RESCUE-ASDH)
IRAS ID
191509
Contact name
Peter Hutchinson
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
ISRCTN Number
ISRCTN87370545
Duration of Study in the UK
5 years, 10 months, 30 days
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.REC name
Scotland A: Adults with Incapacity only
REC reference
15/SS/0193
Date of REC Opinion
28 Jan 2016
REC opinion
Further Information Favourable Opinion