CompletedInterventional

Randomised Evaluation of Surgery with Craniectomy for patients Undergoing Evacuation of Acute Subdural Haematoma (RESCUE-ASDH)

Every year, thousands of people in the UK need urgent surgery after a head injury causes bleeding on the brain, known as an acute subdural haematoma. To relieve dangerous pressure, surgeons remove a section of the skull to clear the blood clot. Surgeons can either put the piece of bone back straight away (a craniotomy) or leave it out temporarily to give a swollen brain extra room (a decompressive craniectomy). If left out, another operation is needed months later to replace it. Both methods are widely used across the NHS, but doctors do not know which leads to a better long-term recovery. The RESCUE-ASDH study compares these two surgical techniques. Patients receive one of the standard operations, and researchers track their recovery through short questionnaires sent at 6 and 12 months.

At a glance

Status

Completed

Sponsor

Cambridge University Hospitals NHS Foundation Trust & University of Cambridge (UK)

Enrolment target

440

Start

01 Oct 2014

Estimated completion

30 Apr 2019

Acute subdural haematoma

What is this study about?

A severe head injury can cause a dangerous bleed between the brain and its protective outer lining. This collection of blood is called an acute subdural haematoma. The clot puts pressure on the brain, which can quickly become life-threatening. Emergency surgery is required to relieve this pressure and remove the blood.

To reach the bleed, a neurosurgeon temporarily removes a piece of the skull bone. Before closing the scalp, the surgeon has two choices. They can put the bone piece back into place straight away (known as a craniotomy), meaning the skull is intact and no second operation is planned. Alternatively, they can leave the bone piece out (known as a decompressive craniectomy). Leaving the bone out gives a swollen brain extra room to expand safely, but it means the patient will need another planned operation a few months later to rebuild the skull.

Both operations are routinely performed in NHS hospitals, but medical science does not yet know which approach gives patients the best long-term recovery and quality of life. The RESCUE-ASDH trial was designed to compare these two options directly. By tracking patient progress over a full year, the study aims to give surgeons clear evidence on the best way to treat these serious injuries in the future.

Key takeaways

The RESCUE-ASDH study compares two standard emergency operations for blood clots on the brain.
One technique puts the skull bone back right away; the other leaves it out temporarily to relieve brain swelling.
Both surgical methods are already widely used across NHS hospitals.
Taking part does not involve extra hospital visits or experimental medicines.
Researchers follow recovery through short questionnaires sent at 6 and 12 months.

Who may be eligible?

This study is for adults aged 16 and over who have suffered a head injury and have an acute subdural haematoma confirmed on a brain CT scan. The neurosurgeon on duty must decide that the blood clot needs urgent surgical removal through a relatively large opening in the skull.

Patients cannot take part if they have severe bleeds on both sides of the head that both require surgery at the same time. People are also excluded if they have taken part in this specific trial before, or if they had a severe pre-existing physical or mental disability that would prevent a good recovery regardless of the head injury.

Because this is an emergency operation, the surgeon makes the final decision inside the operating theatre. If a patient's brain swelling is too severe to safely put the skull bone back, the bone is always left out as normal practice, and the patient will not be randomised in the trial.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Aged 16 years or older
Recent head injury causing a bleed on the brain (acute subdural haematoma)
Emergency surgery needed to remove the clot through a skull opening
Do not have severe bleeds on both sides of the head that both need surgery
No severe pre-existing disability before the injury that would stop recovery

Answer every question to see your result.

What does participation involve?

Because this involves emergency treatment, patients are enrolled when they arrive at the hospital needing urgent surgery. If the surgeon confirms it is safe to do so, a computer randomly selects which of the two standard operations the patient receives: replacing the skull bone or leaving it out temporarily.

Taking part does not involve experimental drugs, extra clinic visits, or additional hospital scans. The patient receives standard NHS care throughout their stay. If the bone was left out, a planned second operation will take place several months later to replace or repair the skull, which is normal practice.

For patients and their families, the only extra requirement is completing a short health questionnaire at 6 months and 12 months after the injury. These questionnaires ask simple questions about everyday activities, mobility, and overall wellbeing. In total, follow-up lasts for one year from the date of the injury.

Potential risks and benefits

There is no guaranteed personal benefit from taking part, but the results help doctors understand which surgical method gives future patients the best chance of recovery. Both surgical options are standard NHS procedures with well-known safety profiles. If severe brain swelling makes replacing the bone unsafe during surgery, the surgeon will always leave it out to keep the patient safe. If the bone is replaced and serious swelling develops later, the patient can return to the operating theatre to have the bone removed. Participation is entirely voluntary, and patients or their families have the right to withdraw from follow-up questionnaires at any point without it affecting standard medical care.

Locations (52)

Addenbrookes Hospital
City only
Cambridge, England
Derriford Hospital
Approximate
Plymouth, England
John Radcliffe Hospital
Approximate
Oxford, England
King's College Hospital
Approximate
London, England
Leeds General Infirmary
Approximate
Leeds, England
Queen Elizabeth Hospital
Unverified
Birmingham, England
Royal Hallamshire Hospital
Unverified
Sheffield, England
Salford Royal Hospital
Unverified
Manchester, England
Southampton General Hospital
Unverified
Southampton, England
St George's Hospital
Unverified
London, England
St Mary's Hospital
Unverified
London, England
The Walton Centre
Unverified
Liverpool, England

Common questions

Why was my relative included in the study without their written consent first?

Emergency brain surgery must happen within hours, and patients are usually unconscious or very unwell. Under strict UK ethical rules, surgeons can safely enrol patients in trials comparing standard treatments, and researchers speak with family members as soon as possible afterwards.

What happens if the skull bone is left out?

The scalp is safely closed over the brain, leaving a soft area that is protected while swelling goes down. A few months later, surgeons perform a planned second operation to rebuild that part of the skull with the original bone or an artificial plate.

Is one surgical option considered safer than the other?

Both operations are standard and used every day in the NHS. Leaving the bone out gives swollen brain tissue more room, but requires a second surgery later. Replacing the bone avoids a second surgery, but might not leave enough room if severe swelling develops.

Will taking part mean more hospital appointments?

No. All hospital care and check-ups follow normal NHS practice. The only extra task is filling in a short recovery questionnaire at 6 and 12 months.

Can we decide to stop taking part later on?

Yes. Patients or their representatives can withdraw from completing the follow-up questionnaires at any time. This will not change or harm standard NHS medical care in any way.

How to find out more

Carol Davis-Wilkie

carol.daviswilkie@addenbrookes.nhs.uk +44 1223 256624 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.