Published: 24 April 2023
Surgeons should - where possible - replace the removed section of the skull following surgery to treat a form of brain bleed, a landmark trial finds.
Researchers say the approach will save patients undergoing skull reconstruction further down the line.
NIHR funded and supported the RESCUE-ASDH study. The international randomised trial involved 40 centres in 11 countries and 450 patients took part. The results published at the annual meeting of the American Association of Neurological Surgeons and in the New England Journal of Medicine yesterday.
One of the life-threatening results of head injury is acute subdural haematoma – a bleed occurring between the brain and skull. It can lead to the build-up of pressure. These bleeds need surgery to stem the blood flow, remove the blood clot and relieve the pressure.
There are two approaches to such surgery. The first is a decompressive craniectomy - involving leaving a section of the skull out – which can be as large as 13cm in length. This protects the patient from brain swelling, often seen with this injury. Typically the missing skull needs reconstruction. Some treatment centres replace the patient’s own bone several months after surgery. In others, they use a manufactured plate.
The second approach is a craniotomy. The skull section is replaced after the bleed is stemmed and the blood clot removed. This approach prevents the need for a skull reconstruction further down the line.
To date there was little conclusive evidence and no accepted criteria for which approach to use. Researchers at the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust launched RESCUE-ASDH to answer this question. Patients were randomly assigned to undergo craniotomy or decompressive craniectomy.
A total of 228 patients underwent craniotomy and 222 decompressive craniectomy. Researchers assessed the outcomes for these patients and their quality of life up to a year after surgery.
Patients in both groups had similar disability-related and quality-of-life outcomes at 12 months post-surgery. There was a trend towards better outcomes with craniotomy.
Around one in four patients (25.6%) in the craniotomy group and one in five (19.9%) in the craniectomy group had a good recovery.
Around one in three patients in both groups (30.2% craniotomy group and 32.2% craniectomy group died within the first 12 months following surgery.
14.6% of the craniotomy group and 6.9% of the craniectomy group required additional cranial surgery within two weeks after randomisation. However, this was balanced due to fewer people in the first group experienced wound complications (3.9% compared to 12.2%).
The trial's Chief Investigator Peter Hutchinson, Professor of Neurosurgery at Cambridge, said: "RESCUE-ASDH is the first multicentre study to address a very common clinical question: which technique is optimal for removing an acute subdural haematoma – a craniotomy or a decompressive craniectomy?
“This was a large trial and the results convincingly show that there is no statistical difference in the 12 month disability-related and quality of life outcomes between the two techniques.”
Co-chief investigator Professor Angelos Kolias, Consultant Neurosurgeon at Cambridge, said: "Based on the trial findings, we recommend that after removing the blood clot, if the bone flap can be replaced without compression of the brain, surgeons should do so, rather than performing a pre-emptive decompressive craniectomy.
“This approach will save patients from having to undergo a skull reconstruction, which carries the risk of complications and additional healthcare costs, further down the line.”
Professor Andrew Farmer, Director of NIHR’s Health Technology Assessment (HTA) Programme, which funded the study, said: “The findings of this world-leading trial provide important evidence which will improve the way patients with head injuries are treated.
“High quality, independently funded research like this is vital in providing evidence to improve health and social care practice and treatments. Research is crucial in informing those who plan and provide care.”
The NIHR Global Health Research Group on Acquired Brain and Spine Injury and the NIHR Clinical Research Network (CRN) supported the study.
The CENTER-TBI project of the European Brain Injury Consortium, and the Royal College of Surgeons of England Clinical Research Initiative supported it too.