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1. Fewer patients in the decompressive craniectomy group had an mRS score of 5-6 compared to medical treatment alone, although this difference was not statistically significant.

2. Severe adverse events were comparable between both groups.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Spontaneous intracerebral hemorrhage is commonly associated with strokes worldwide. Although decompressive craniectomy reduces mortality in people with large vessel infarction, its role in the management of severe deep supratentorial intracerebral hemorrhage remains unclear. This randomized controlled trial aimed to assess whether decompressive craniectomy plus best medical treatment is superior to best medical treatment alone. The primary outcome of this study was a score ≥ 5 on the modified Rankin Scale (mRS) at 6 months, while a key secondary outcome was the occurrence of severe adverse events. According to study results, decompressive craniectomy plus best medical treatment showed a non-significant improvement compared to best medical treatment alone with regards to the primary outcome. A major limitation of this study was early termination due to lack of funding.

Click to read the study in The Lancet

Relevant Reading: Decompressive Craniectomy versus Craniotomy for Acute Subdural Hematoma

In-depth [randomized controlled trial]: Between Oct 6, 2014, and Apr 4, 2023, 234 patients were enrolled from 42 stroke centers in 9 countries. Included were patients ≥ 18 years with severe intracerebral hemorrhage involving the basal ganglia or thalamus. Altogether, 201 patients (96 in the decompressive craniectomy group and 101 in the best medical treatment alone group) were included in the final analysis. The primary outcome of MRS score ≥ 5 at 6 months was lesser in the decompressive craniectomy plus medical treatment group compared to medical treatment alone (44% vs. 58%, adjusted risk ratio [aRR] 0.77, 95% confidence interval [CI] 0.59-1.01, p=0.057). The secondary outcome of severe adverse events was similar in both groups (41% vs. 44%). Findings from this study suggest that decompressive craniectomy plus best medical treatment may provide a weak benefit over best medical treatment alone in patients with severe deep intracerebral hemorrhage.

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