Date opened: March 2015
Type: Pragmatic, parallel group randomised Controlled Trial
Current status: Open
Recruitment to date: 3
Lead researcher (overall study): Prof Tony Hutchinson (University of Cambridge)
Lead researcher (SRMRC): Prof Tony Belli
In about one third of people who have a severe brain injury, bleeding occurs between the membrane lining the brain (the dura) and the brain itself. The clot which develops is called an acute subdural haematoma. This causes swelling and pressure on the brain, which may cause further damage, so surgery is needed to remove the clot. Two types of operation –both occurring under general anaesthesia with the patient fully asleep– are possible: a craniotomy and a decompressive craniectomy. Currently, there is no alternative treatment other than the two operations in this study.
In a craniotomy, the skin is opened, a piece of skull is removed, the clot is removed and the piece of skull is replaced before closing the skin.
In a decompressive craniectomy, the skin is opened, a piece of skull is removed, the clot is removed but the piece of skull is not replaced before closing the skin.
Craniotomy has the advantage of only having one operation but may not be as effective at controlling brain swelling. Decompressive craniectomy has the advantage that leaving the bone out at the time of initial surgery may help control brain swelling but a second operation is required a few months later to reconstruct the skull either with the original piece of skull or a plate made from synthetic materials. The choice of material will be decided following consultation with a neurosurgeon.
The only way to find out which of these two operations is the best is to compare them in patients who have an acute subdural haematoma after a head injury, which is the aim of this trial.
Who is eligible?
Patients who sustained a severe brain injury and developed an acute subdural haematoma which requires surgery to remove.
To be included in the trial the patient must:
- Patients > 16 years
- Acute subdural haematoma on CT
- The admitting neurosurgeon feels that the acute subdural haematoma needs to be evacuated either by a craniotomy or decompressive craniectomy (bone flap >11 cm)*
The presence of any of the following will preclude patient inclusion:
- Bilateral unresponsive dilated pupils of ≥5mm and/or brainstem injuries on CT
- Uncorrected coagulopathy
- Bilateral acute subdural haematomas both requiring evacuation
- Previous enrolment in RESCUE-ASDH study
- Severe pre-existing physical or mental disability or severe co-morbidity which would lead to a poor outcome even if the patient made a full recovery from the head injury
Following admission to hospital, patients requiring surgery will be randomised to one of two surgical procedures:
- Group A: One half of patients will receive a craniotomy
- Group B: One half of patients will receive a decompressive craniectomy
Patients will then complete follow up questionnaires at 6-months and 1 year following the operation, to help establish which surgical procedure is more effective for recovery and most cost-effective.
The study will help hospitals and doctors determine which type of operation to use in the future for patients with this injury.
The primary outcome measure will be the GOSE (extended Glasgow Outcome Scale) at 12 months post-injury. The use of the GOSE as a core global outcome measure is recommended by the interagency TBI Outcomes Workgroup and the International Mission for Prognosis and Analysis of Clinical Trials in TBI group (IMPACT Common Data Elements).
The secondary measures are:
- GOSE at 6 months post-injury
- Quality of life (EQ-5D) at discharge from neurosurgical unit (NSU), 6 and 12 months post-injury
- Glasgow Coma Scale (GCS) on discharge from the intensive care unit (ICU) and from NSU
- Length of stay in ICU, neurosurgical and rehabilitation unit
- Therapy Intensity Level (IMPACT-TBI scale) in the ICU
- Discharge destination from NSU
- Serious adverse events & surgical complications during index admission
- Cranial surgery within 2 weeks after randomisation
- Subsequent readmissions to the NSU within the 12 months follow-up period
- Hydrocephalus requiring shunt insertion within the 12 months follow-up period
- Health care services utilisation over 12 months
- Detailed economic evaluation