University of Cambridge-led study recommends surgeons replace section of skull after operating on brain bleeds

An international trial involving Cambridge University Hospital NHS Trust has concluded that surgeons carrying out procedures to treat a form of brain haemorrhage should replace the removed section of skull afterwards where possible.

This prevents patients having to undergo skull reconstruction at a later stage.

Forty centres in 11 countries, and 450 patients, were involved in the RESCUE-ASDH trial.

Funded by the UK’s National Institute for Health and Care Research (NIHR), it explored the two surgical approaches used to deal with one of the potentially life-threatening results of head injury - acute subdural haematoma.

This is a bleed between the brain and skull that can lead to the build-up of pressure.

Surgery is required to stem the bleeding, remove the blood clot and relieve the pressure.

If a decompressive craniectomy is carried out, a section of the skull out – which can be as large as 13cm long – to protect the patient from brain swelling. The missing skull typically requires reconstruction, which some treatment centres carry out using the patient’s own bone months after surgery. At other centres, a manufactured plate is used.

Alternatively a craniotomy can be performed, in which the skull section is replaced after the haemorrhage has been stemmed and the blood clot removed, negating the need for later skull reconstruction.

Prof Peter Hutchinson, professor of neurosurgery at Cambridge and the trial's chief investigator, said: "The international randomised trial 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 (putting the bone back) or a decompressive craniectomy (leaving the bone out)?

“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.”

The research team, led by the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust, carried out a randomised trial to assess the approaches, with 228 patients assigned to the craniotomy group and 222 to the decompressive craniectomy group and their outcomes and quality of life measured up to a year after surgery.

Both groups had similar disability-related and quality-of-life outcomes at 12 months after surgery. There was a trend towards better outcomes with craniotomy - 25.6 per cent compared to 19.9 per cent -, but this was not statistically significant.

Just under a third of patients in both groups died within the first 12 months following surgery.

Some 14.6 per cent of the craniotomy group required additional cranial surgery within two weeks after randomisation, compared to 6.9 per cent of the decompressive craniectomy group. But fewer people in the craniotomy group experienced wound complications - (3.9 per cent compared to 12.2 per cent

Prof Angelos Kolias, consultant neurosurgeon at Cambridge and the trial's co-chief investigator, 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.”

The researchers say the findings may not be relevant for resource-limited or military settings, where pre-emptive decompressive craniectomy is often used due the lack of advanced intensive care facilities for post-operative care.

Prof Andrew Farmer, director of NIHR’s health technology assessment (HTA) programme, 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 RESCUE-ASDH trial was supported by the NIHR Global Health Research Group on Acquired Brain and Spine Injury, the CENTER-TBI project of the European Brain Injury Consortium, and the Royal College of Surgeons of England Clinical Research Initiative.