Craniectomy significantly reduces the risk of death following traumatic brain injury (TBI), an international study led by the University of Cambridge has found.
Traumatic brain injury is a serious injury to the brain, often caused by road traffic accidents, assaults or falls. It can lead to dangerous swelling in the brain which, in turn, can lead to brain damage or even death. A team led by researchers at the department of clinical neurosciences, University of Cambridge, and based at Addenbrooke’s Hospital, recruited over 400 traumatic brain injury patients over a ten-year period from the UK and another 19 countries worldwide. They then randomly assigned the patients to one of two groups for treatment – craniectomy or medical management.
In the research, the researchers report that six months after the head injury, just over one in four patients (27%) who received a craniectomy had died compared to just under a half (49%) of patients who received medical management. However, the picture was complicated as patients who survived after a craniectomy were more likely to be dependent on others for care (30.4% compared to 16.5%).
Further follow-up showed that patients who survived following a craniectomy continued improving from six to 12 months after injury. As a result, at 12 months, nearly half of craniectomy patients were at least independent at home (45.4%), as compared with one-third of patients in the medical group (32.4%).
Peter Hutchinson, professor of neurosurgery at the department of clinical neurosciences at Cambridge, says: “Traumatic brain injury is an incredibly serious and life-threatening condition. From our study, we estimate that craniectomies can almost halve the risk of death for patients with a severe traumatic brain injury and significant swelling. Importantly, this is the first high-quality clinical trial in severe head injury to show a major difference in outcome. However, we need to be really conscious of the quality of life of patients following this operation which ranged from vegetative state through varying states of disability to good recovery.”
Angelos Kolias, clinical lecturer at the department, adds: “Doctors and families will need to be aware of the wide range of possible long-term outcomes when faced with the difficult decision as to whether to subject someone to what is a major operation. Our next step is to look in more detail at factors that predict outcome and at ways to reduce any potential adverse effects following surgery. We are planning to hold a consensus meeting in Cambridge next year to discuss these issues.”
The research was funded by the Medical Research Council and managed by the National Institute for Health Research (NIHR) on behalf of the MRC–NIHR partnership, with further support from the NIHR Cambridge Biomedical Research Centre, the Academy of Medical Sciences, the Health Foundation, the Royal College of Surgeons of England and the Evelyn Trust.
Background: The effect of decompressive craniectomy on clinical outcomes in patients with refractory traumatic intracranial hypertension remains unclear.
Methods: From 2004 through 2014, we randomly assigned 408 patients, 10 to 65 years of age, with traumatic brain injury and refractory elevated intracranial pressure (>25 mm Hg) to undergo decompressive craniectomy or receive ongoing medical care. The primary outcome was the rating on the Extended Glasgow Outcome Scale (GOS-E) (an 8-point scale, ranging from death to “upper good recovery” [no injury-related problems]) at 6 months. The primary-outcome measure was analyzed with an ordinal method based on the proportional-odds model. If the model was rejected, that would indicate a significant difference in the GOS-E distribution, and results would be reported descriptively.
Results: The GOS-E distribution differed between the two groups (P<0.001). The proportional-odds assumption was rejected, and therefore results are reported descriptively. At 6 months, the GOS-E distributions were as follows: death, 26.9% among 201 patients in the surgical group versus 48.9% among 188 patients in the medical group; vegetative state, 8.5% versus 2.1%; lower severe disability (dependent on others for care), 21.9% versus 14.4%; upper severe disability (independent at home), 15.4% versus 8.0%; moderate disability, 23.4% versus 19.7%; and good recovery, 4.0% versus 6.9%. At 12 months, the GOS-E distributions were as follows: death, 30.4% among 194 surgical patients versus 52.0% among 179 medical patients; vegetative state, 6.2% versus 1.7%; lower severe disability, 18.0% versus 14.0%; upper severe disability, 13.4% versus 3.9%; moderate disability, 22.2% versus 20.1%; and good recovery, 9.8% versus 8.4%. Surgical patients had fewer hours than medical patients with intracranial pressure above 25 mm Hg after randomization (median, 5.0 vs. 17.0 hours; P<0.001) but had a higher rate of adverse events (16.3% vs. 9.2%, P=0.03).
Conclusions: At 6 months, decompressive craniectomy in patients with traumatic brain injury and refractory intracranial hypertension resulted in lower mortality and higher rates of vegetative state, lower severe disability, and upper severe disability than medical care. The rates of moderate disability and good recovery were similar in the two groups.
Peter J Hutchinson, Angelos G Kolias, Ivan S Timofeev, Elizabeth A Corteen, Marek Czosnyka, Jake Timothy, Ian Anderson, Diederik O Bulters, Antonio Belli, C Andrew Eynon, John Wadley, A David Mendelow, Patrick M. Mitchell, Mark H Wilson, Giles Critchley, Juan Sahuquillo, Andreas Unterberg, Franco Servadei, Graham M Teasdale, John D Pickard, David K Menon, Gordon D Murray, Peter J Kirkpatrick