RESCUEicp
Trial question
What is the effect of decompressive craniectomy on clinical outcomes in patients with refractory traumatic intracranial hypertension?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
19.0% female
81.0% male
N = 398
398 patients (77 female, 321 male).
Inclusion criteria: patients with traumatic brain injury and refractory elevated ICP (> 25 mmHg).
Key exclusion criteria: bilateral fixed and dilated pupils, bleeding diathesis, or an injury that was deemed to be unsurvivable.
Interventions
N=202 surgical (decompressive craniectomy with medical therapy).
N=196 medical (continued medical therapy with the option of adding barbiturates to reduce ICP).
Primary outcome
Death at 6 months
26.9%
48.9%
48.9 %
36.7 %
24.4 %
12.2 %
0.0 %
Surgical
Medical
Significant
decrease ▼
NNT = 4
Significant decrease in death at 6 months (26.9% vs. 48.9%; AD -22.1%, 95% CI -31.5 to -12.7).
Safety outcomes
Significant differences in adverse events (16.3% vs. 9.2%, p = 0.03) and hours with ICP > 25 mmHg (median, 5.0 vs. 17.0 hours, p < 0.001).
Conclusion
In patients with traumatic brain injury and refractory elevated ICP (> 25 mmHg), surgical was superior to medical with respect to death at 6 months.
Reference
Hutchinson PJ, Kolias AG, Timofeev IS et al. Trial of Decompressive Craniectomy for Traumatic Intracranial Hypertension. N Engl J Med. 2016 Sep 22;375(12):1119-30.
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