DECRA
Trial question
What is the role of early bifrontotemporoparietal decompressive craniectomy in patients with severe diffuse traumatic brain injury and refractory intracranial hypertension?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
23.0% female
77.0% male
N = 155
155 patients (35 female, 120 male)
Inclusion criteria: adult patients with severe diffuse traumatic brain injury and refractory intracranial hypertension
Key exclusion criteria: patients deemed unsuitable for full active treatment; patients with dilated, unreactive pupils; mass lesions; spinal cord injury; or cardiac arrest at the scene of the injury
Interventions
N=73 decompressive craniectomy (early bifrontotemporoparietal craniectomy with bilateral dural opening to maximize the reduction in ICP plus standard care)
N=82 standard care (standard care alone)
Primary outcome
Proportion of patients with an unfavorable outcome at 6 months
70
51
70.0 %
52.5 %
35.0 %
17.5 %
0.0 %
Decompressive
craniectomy
Standard
care
Significant
increase ▲
NNH = 5
Significant increase in proportion of patients with an unfavorable outcome at 6 months (70% vs. 51%; OR 2.21, 95% CI 1.14 to 4.26)
Secondary outcomes
Significant decrease in ICP (14.4 mmHg vs. 19.1 mmHg; AD -4.7 mmHg, 95% CI -7.49 to -1.91)
Significant decrease in median intracranial hypertension index (11.5 vs. 19.9 ; AD -8.4 , 95% CI -13.38 to -3.42)
Significant decrease in median days of ICU stay (13 days vs. 18 days; AD -5 days, 95% CI -7.97 to -2.03)
Safety outcomes
No significant differences in death, wound infection or breakdown, meningitis, or ventriculitis.
Conclusion
In adult patients with severe diffuse traumatic brain injury and refractory intracranial hypertension, decompressive craniectomy was inferior to standard care with respect to proportion of patients with an unfavorable outcome at 6 months.
Reference
D James Cooper, Jeffrey V Rosenfeld, Lynnette Murray et al. Decompressive craniectomy in diffuse traumatic brain injury. N Engl J Med. 2011 Apr 21;364(16):1493-502.
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