Safety and efficacy of decompressive craniectomy versus standard craniotomy for large acute epidural haematoma with tentorial herniation in China (PREDICT-AEDH): a nationwide, multicentre, open-label, parallel-group, randomised controlled trial.

Abstract

Background: Decompressive craniectomy has been widely evaluated across heterogeneous types of brain injury but its effect in patients with large acute epidural haematoma complicated by tentorial herniation remains unclear. We aimed to assess whether decompressive craniectomy improves functional and safety outcomes compared with standard craniotomy in this patient group.

Methods: The Prospective Randomised Evaluation of Decompressive Ipsilateral Craniectomy for Traumatic Acute Epidural Haematoma (PREDICT-AEDH) trial was a nationwide, multicentre, open-label, parallel-group, randomised controlled trial conducted at 28 hospitals in China. Adults aged 18-65 years with clinical signs of transtentorial herniation, CT-confirmed large acute epidural haematoma, and obliterated ambient cistern within 12 h of injury were randomly assigned (1:1) to primary decompressive craniectomy or standard craniotomy with bone-flap replacement, using a secure, central, web-based randomisation system with block sizes of four. Although masking of patients and surgeons was not feasible, all assessments and analyses were done by masked investigators. The primary outcome was functional status at 6 months in all randomised patients according to intention to treat (ITT), assessed using the Glasgow Outcome Scale-Extended (GOSE) and analysed with a proportional-odds model. No imputation for missing outcome data was done since no participants were lost to follow-up. Safety outcomes were assessed in the ITT population. The trial is registered with ClinicalTrials.gov (NCT04261673) and is complete.

Findings: Between Sept 7, 2020, and March 14, 2025, 142 patients were screened for eligibility, of whom 120 patients (15 [12%] females and 105 [88%] males) were randomly assigned to decompressive craniectomy (n=58) or standard craniotomy (n=62). One patient assigned to the decompressive craniectomy group received craniotomy and ten patients assigned to craniotomy received decompressive craniectomy. At 6 months, a favourable functional outcome (GOSE ≥5) occurred in 46 (79%) of 58 patients assigned to decompressive craniectomy and 52 (84%) of 62 patients assigned to standard craniotomy. Ordinal analysis of GOSE failed to show a significant difference between groups (common OR 0·79 [0·41-1·58]; p=0·51). Rates were similar between the decompressive craniectomy and standard craniotomy groups for 30-day mortality (five [9%] of 58 patients vs three [5%] of 62 patients) and postoperative cerebral infarction (11 [19%] vs 11 [18%]). Delayed intracranial haemorrhage occurred more frequently after decompressive craniectomy (21 [36%] of 58 patients) than after standard craniotomy (eight [13%] of 62 patients; OR 3·79, 95% CI 1·43-11·00; p=0·0049).

Interpretation: In patients with large acute epidural haematoma and tentorial herniation, decompressive craniectomy did not improve 6-month functional outcomes compared with standard craniotomy and increased the risk of delayed intracranial haemorrhage. These findings therefore do not support routine prophylactic decompressive craniectomy in this population.

Funding: None.