Authors' objectives: Traumatic acute subdural haematomas often require surgical evacuation via craniotomy or decompressive craniectomy. Decompressive craniectomy may prevent intracranial hypertension; however, it is unclear whether it is associated with better outcomes. Multicentre, pragmatic, parallel-group randomised trial to compare the clinical and cost-effectiveness of decompressive craniectomy versus craniotomy for evacuation of acute subdural haematomas. Approximately 4000 head-injured patients undergo emergency brain surgery each year in the UK, of whom two-thirds have a blood clot between the outer lining of the brain and the brain itself, known as an acute subdural haematoma, and if not removed, it can be life-threatening. When an acute subdural haematoma is evacuated, a piece of skull can be left out, known as a decompressive craniectomy, or replaced prior to closing the skin, known as a craniotomy. Acute subdural haematoma (ASDH) is a common consequence of traumatic brain injury (TBI) and is associated with a high mortality rate. These haematomas are commonly treated with surgical evacuation using two different surgical procedures: craniotomy or decompressive craniectomy (DC). In a craniotomy, the skin is opened, a piece of skull is removed, the haematoma evacuated, the piece of skull replaced and the skin closed. DC is a similar procedure, but the piece of skull is not replaced prior to closing the skin. The advantage of a DC is that it is thought to be superior in controlling brain swelling, but the patient will require a further operation to rebuild their skull usually weeks or months later, known as cranioplasty. The advantage of a craniotomy is the patient will not require a second operation to rebuild their skull, but it is believed to be inferior at controlling life-threatening brain swelling that can occur after the operation. Both procedures are commonly performed worldwide, but there is no level-one evidence comparing them. Thus, we conducted the RESCUE (randomised evaluation of surgery with craniectomy for patients undergoing evacuation of acute subdural haematoma)-ASDH trial to compare the effectiveness and cost-effectiveness of craniotomy versus DC in patients with ASDH. Primary Compare the long-term clinical effectiveness of DC versus craniotomy.

Authors' results and conclusions: Four hundred and fifty patients were randomised: 228 to craniotomy and 222 to craniectomy – with the common odds ratio for the differences across the Glasgow Outcome Scale scores of 0.85 [95% confidence interval (0.6 to 1.18; p = 0.324)]. The results were similar at 6 months. At 12 months, death occurred in 30.2% of the craniotomy group versus 32.2% of the decompressive craniectomy group, vegetative state occurred in 2.3% versus 2.8%, and good recovery occurred in 25.6% and 19.9%, respectively. In the observed cohort, those who had a decompressive craniectomy had significantly worse outcomes at 6 and 12 months, but their baseline characteristics were different. Among patients undergoing evacuation of acute subdural haematomas, the outcomes were similar in both groups. Additional surgery was required in a higher proportion of patients in the craniotomy group, but more wound complications occurred in the decompressive craniectomy group. The analysis of the randomised patients showed no significant difference in the functional outcomes of the two arms at 12 months, but there were differences in functional outcomes between the groups in the observed cohort; however, patients undergoing decompressive craniectomy were worse before the operation. UK craniotomy patients were estimated to have lower costs and a higher quality of life than decompressive craniectomy patients. Among patients undergoing evacuation of a traumatic acute subdural haematoma, decompressive craniectomy did not result in better outcomes than craniotomy and was not considered to represent value for money. Primary outcome (randomised) In the modified ITT analysis (ordinal analysis based on the proportional odds model), there was no significant difference between the two groups with regard to GOSE scores at 12 months [common OR 0.845; 95% confidence interval (CI), 0.6 to 1.18; p = 0.324]. The distribution of GOSE scoring across the two groups was: death, 30.2% among 215 patients in the craniotomy group versus 32.2% among 211 patients in the DC group; vegetative state, 2.3% versus 2.8%; lower severe disability (dependent on others for care), 17.7% versus 19.4%; upper severe disability (independent at home), 13.0% versus 12.8%; moderate disability, 11.2% versus 12.8%; and good recovery, 25.6% versus 19.9%. Among adult patients undergoing evacuation of a traumatic ASDH, a DC did not result in better outcomes than craniotomy in the randomised cohort. Secondary craniectomies were most frequently performed in the craniotomy group, but wound-related complications and surgical site infections occurred more frequently in the craniectomy group. Craniotomy was estimated to be cost-effective compared to craniectomy.

Authors' recommendations: Evaluation of the timing of cranial reconstruction on functional recovery. Long-term outcome following DC.

Authors' methods: International, multicentre, pragmatic, parallel-group randomised trial with additional observational arm. Hospitals with neurosurgical services in the UK and internationally. Patients aged ≥ 16 years, with a diagnosis of acute subdural haematomas on a computed tomography scan that required evacuation with a large bone flap either by craniotomy or decompressive craniectomy according to the opinion of the admitting neurosurgeon. The enrolled patients underwent acute subdural haematoma evacuation in the operating room under general anaesthesia. A large bone flap ipsilateral to the haematoma was raised, the dura opened and the haematoma evacuated. Other haematomas, such as contusions, were evacuated at the discretion of the surgeon. If clinically appropriate randomisation occurred, the bone flap was either replaced (craniotomy) or not replaced (decompressive craniectomy). Patients who could not be randomised were followed up in the observational arm. Primary outcome measure was the extended Glasgow Outcome Scale assessed 12 months post injury. An economic evaluation (based on UK participants) was undertaken to estimate the cost-effectiveness of craniotomy compared to decompressive craniectomy. Clinicians were not blinded to the trial groups. Decompressive craniectomy was performed in 8.8% of patients allocated to the craniotomy group, and 5.4% of patients allocated to the decompressive craniectomy group underwent craniotomy. Intraoperative non-adherence with allocation did not influence the primary analysis, which was based on the intention-to-treat principle. This study was a head-to-head comparison of craniotomy and decompressive craniectomy as to whether one is better for the management of acute subdural haematoma. Following consent, the patients were randomly allocated to receive either craniotomy or decompressive craniectomy. Patients unsuitable for inclusion had the operation deemed to be in their best interest by the operating neurosurgeon, and all participants were followed up for 1 year. To assess the value for money, data from UK patients were collected in relation to both health and social service usage and health-related quality of life. Trial design An international multicentre, pragmatic, parallel-group randomised trial to compare the effectiveness of craniotomy versus DC for the management of adult head-injured patients undergoing evacuation of an ASDH. In addition, an observational cohort included eligible patients enrolled into the study who could not be randomised after evacuation of haematoma due to significant swelling of the brain, or patients who had a traumatic ASDH removed as part of their standard care and who were enrolled postoperatively.

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hta/12/35/57

Year Published: 2026

URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/GJPH0512

URL for additional information: English

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: England, United Kingdom

DOI: 10.3310/GJPH0512

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk