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
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PREDICT-AEDH decompressive craniectomy epidural haematoma
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PREDICT-AEDH trial decompressive craniectomy versus standard craniotomy acute epidural haematoma tentorial herniation China RCT 2024 2025
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PMID: 42309085
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https://www.em-consulte.com/article/1823794/tableaux/safety-…
Here is a detailed summary and critical appraisal of the PREDICT-AEDH trial:
PREDICT-AEDH Trial - Summary & Critical Appraisal
Citation: Feng J, Yang C, Xie L, et al. Lancet Neurology, July 2026. DOI: 10.1016/S1474-4422(26)00143-2 | PMID: 42309085
Background & Rationale
Decompressive craniectomy (DC) - where the bone flap is permanently removed after haematoma evacuation - has been used prophylactically in patients with large acute epidural haematoma (AEDH) and transtentorial herniation, on the premise that leaving the skull open reduces secondary brain swelling. However, prior to this trial, no randomised evidence existed specifically for this high-risk subgroup. Standard craniotomy replaces and fixes the bone flap after evacuation.
Study Design
| Feature | Detail |
|---|---|
| Design | Nationwide, multicentre, open-label, parallel-group RCT |
| Registration | NCT04261673 |
| Sites | 28 hospitals across China |
| Enrolment period | September 7, 2020 - March 14, 2025 |
| Randomisation | 1:1, central web-based, block size 4 |
| Masking | Surgeons and patients unblinded (not feasible); all outcome assessors masked |
| Funding | None declared; no competing interests |
Inclusion Criteria
- Adults aged 18-65 years
- Clinical signs of transtentorial herniation
- CT-confirmed large AEDH
- Obliterated ambient cistern on CT
- Within 12 hours of injury
Interventions
- DC arm: Haematoma evacuation + decompressive craniectomy (bone flap removed, not replaced)
- Craniotomy arm: Haematoma evacuation + standard craniotomy with bone-flap replacement and fixation
Results
Population: 142 screened; 120 randomised (n=58 DC; n=62 craniotomy). Demographics: 88% male, age range 18-65 years. Notably, 10 patients assigned to craniotomy crossed over to DC, and 1 DC patient received craniotomy, suggesting some intraoperative discretion was exercised.
Primary Outcome: GOSE at 6 Months (ITT, Ordinal Analysis)
| Outcome | DC (n=58) | Craniotomy (n=62) | Effect |
|---|---|---|---|
| Favourable outcome (GOSE ≥5) | 46/58 (79%) | 52/62 (84%) | - |
| Ordinal GOSE (proportional odds) | - | - | common OR 0.79 (95% CI 0.41-1.58); p=0.51 |
No significant difference in 6-month functional outcomes.
Secondary / Safety Outcomes
| Outcome | DC (n=58) | Craniotomy (n=62) | OR / p-value |
|---|---|---|---|
| 30-day mortality | 5/58 (9%) | 3/62 (5%) | NS |
| Postoperative cerebral infarction | 11/58 (19%) | 11/62 (18%) | NS |
| Delayed intracranial haemorrhage | 21/58 (36%) | 8/62 (13%) | OR 3.79 (95% CI 1.43-11.00); p=0.0049 |
The significantly higher rate of delayed intracranial haemorrhage in the DC group is the major safety signal.
Authors' 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."
Critical Appraisal
Strengths:
- First randomised evidence specifically addressing DC vs craniotomy for AEDH with herniation - fills a genuine evidence gap
- Multicentre (28 hospitals), nationwide scope increases generalisability within China
- Masked outcome assessment despite unblinded intervention
- No loss to follow-up (zero missing primary outcome data)
- Prospectively registered protocol (NCT04261673)
- No commercial funding; no conflicts of interest declared
Limitations:
- Relatively small sample (n=120): Trial may have been underpowered to detect a meaningful difference in the primary outcome; the point estimate (OR 0.79) numerically favours craniotomy but is imprecise
- High crossover rate: 10/62 (16%) craniotomy patients received DC instead - this dilutes the ITT analysis and may reflect intraoperative clinical judgement overriding randomisation
- Open-label design: Surgical interventions cannot be blinded, but surgeon-level performance variation is an uncontrolled factor across 28 sites
- Restricted age range (18-65): Results may not apply to elderly patients, who carry distinct pathophysiology and outcomes
- China-specific: Case mix, CT thresholds for "large AEDH," and surgical volume characteristics may differ from other healthcare systems
- Mechanism of increased delayed haemorrhage unclear: The ~3x higher rate of delayed intracranial haemorrhage with DC is biologically plausible (loss of tamponade effect after bone removal) but not mechanistically explored in the paper
Clinical Bottom Line
Standard craniotomy with bone-flap replacement achieves equivalent 6-month functional outcomes to decompressive craniectomy in patients with large AEDH and tentorial herniation, while carrying a substantially lower risk of delayed intracranial haemorrhage (13% vs 36%). This trial provides the first randomised data to challenge the rationale for prophylactic DC in this specific population, and supports standard craniotomy as the procedure of choice - avoiding the need for subsequent cranioplasty and its associated morbidity.
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