ENRICH
Trial question
What is the role of early minimally invasive hematoma evacuation in patients with acute intracerebral hemorrhage?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
50.0% female
50.0% male
N = 300
300 patients (150 female, 150 male).
Inclusion criteria: patients who had a lobar or anterior basal ganglia hemorrhage with a hematoma volume of 30-80 mL.
Key exclusion criteria: uncorrectable coagulopathy; need for long-term anticoagulation; very poor or very good results on neurologic examinations; intraventricular hemorrhage involving > 50% of either lateral ventricle; primary thalamic or infratentorial hemorrhage; or any secondary cause of intracerebral hemorrhage.
Interventions
N=150 surgery (minimally invasive surgical removal of the hematoma plus guideline-based medical management).
N=150 medical management (guideline-based medical management alone).
Primary outcome
Mean score on utility-weighted modified Rankin Scale score at day 180
0.458 points
0.374 points
0.5 points
0.3 points
0.2 points
0.1 points
0.0 points
Surgery
Medical
management
Significant
increase ▲
Significant increase in mean score on the utility-weighted mRS score at day 180 (0.458 points vs. 0.374 points; AD 0.084 points, 95% CI 0.01 to 0.16).
Secondary outcomes
Significant decrease in ICU length of stay (6.9 days vs. 9.7 days; AD -2.832 days, 95% CI -4.53 to -1.13).
Significant decrease in hospital length of stay (14.9 days vs. 18.1 days; AD -3.125 days, 95% CI -5.9 to -0.39).
No significant difference in mRS score ≤ 3 at day 180 (50.3% vs. 41%; AD 9.2%, 95% CI -2 to 20.3).
Safety outcomes
Significant difference in death by day 30 (9.3% vs. 18.0%).
Conclusion
In patients who had a lobar or anterior basal ganglia hemorrhage with a hematoma volume of 30-80 mL, surgery was superior to medical management with respect to mean score on the utility-weighted mRS score at day 180.
Reference
Gustavo Pradilla, Jonathan J Ratcliff, Alex J Hall et al. Trial of Early Minimally Invasive Removal of Intracerebral Hemorrhage. N Engl J Med. 2024 Apr 11;390(14):1277-1289.
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