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RCT: Early minimally invasive surgery may improve outcomes in selected patients with intracerebral hemorrhage – N Engl J Med

25 May, 2024 | 18:58h | UTC

Study Design and Population: This multicenter randomized clinical trial investigated the efficacy of early minimally invasive surgical removal of intracerebral hemorrhage compared to medical management alone. The trial enrolled 300 patients within 24 hours of symptom onset, who had either lobar or anterior basal ganglia hemorrhages, with hematoma volumes ranging from 30 to 80 ml. An adaptation rule was applied partway through the trial, resulting in the exclusive enrollment of patients with lobar hemorrhages after 175 patients were initially enrolled.

Main Findings: Patients in the surgery group achieved a significantly higher mean score on the utility-weighted modified Rankin scale at 180 days (0.458) compared to the control group (0.374), with a difference of 0.084 and a posterior probability of superiority of 0.981. Notably, the benefit of surgery was pronounced among patients with lobar hemorrhages (mean difference 0.127), whereas no benefit was observed in patients with anterior basal ganglia hemorrhages. Additionally, the surgery group experienced a lower 30-day mortality rate (9.3%) compared to the control group (18.0%).

Implications for Practice: The results suggest that early minimally invasive surgery for intracerebral hemorrhage, particularly for lobar hemorrhages, offers significant functional benefits over medical management alone. These findings support the selective use of this surgical approach in clinical settings, potentially leading to improved patient outcomes. Further studies could explore the differential impact of hemorrhage location on surgical outcomes to refine treatment guidelines.

 

Reference (link to abstract – $ for full-text):

Pradilla, G. et al. (2024). Trial of Early Minimally Invasive Removal of Intracerebral Hemorrhage. N Engl J Med, 390(14), 1277-1289. DOI: 10.1056/NEJMoa2308440.

 


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