Decompressive craniectomy versus craniotomy for patients undergoing surgical evacuation of an acute subdural hematoma: RESCUE-ASDH RCT and cost effectiveness.

BACKGROUND

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.

OBJECTIVE

Multicentre, pragmatic, parallel-group randomised trial to compare the clinical and cost-effectiveness of decompressive craniectomy versus craniotomy for evacuation of acute subdural haematomas.

DESIGN

International, multicentre, pragmatic, parallel-group randomised trial with additional observational arm.

SETTING

Hospitals with neurosurgical services in the UK and internationally.

PARTICIPANTS

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.

INTERVENTIONS: 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.

MAIN OUTCOME MEASURES: 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.

RESULTS

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.

LIMITATIONS: 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.

CONCLUSIONS

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.

FUTURE WORK: Long-term outcomes of patients following decompressive craniectomy, timing and impact of cranial reconstruction on a patient's rehabilitation.

TRIAL REGISTRATION: This trial is registered as ISRCTN87370545.

FUNDING: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 12/35/57) and is published in full in Health Technology Assessment; Vol. 30, No. 66. See the NIHR Funding and Awards website for further award information.