Propranolol in severe TBI
Trial question
What is the effect of propranolol in patients with severe traumatic brain injury?
Study design
Single center
Open label
RCT
Population
Characteristics of study participants
14.0% female
86.0% male
N = 219
219 patients (30 female, 189 male).
Inclusion criteria: adult patients with a severe traumatic brain injury, intracranial Abbreviated Injury Scale ≥ 3.
Key exclusion criteria: pre-injury β-blocker therapy, persistent shock at 24 h after admission, and transfer from another hospital.
Interventions
N=99 β-blocker therapy positive (20 mg propranolol PO every 12 hours up to 10 days or until discharge).
N=120 β-blocker therapy negative (no propranolol).
Primary outcome
Death in hospital
8.1%
16.7%
16.7 %
12.5 %
8.3 %
4.2 %
0.0 %
Beta-blocker therapy
positive
Beta-blocker therapy
negative
No significant
difference ↔
No significant difference in death in the hospital (8.1% vs. 16.7%; aIRR 0.6, 95% CI 0.3 to 1.4).
Secondary outcomes
Significant decrease in death in the hospital in patients with isolated traumatic brain injury (4.4% vs. 18.6%; aIRR 0.32, 95% CI 0.1 to 0.9).
Significant increase in the rate of functional outcome at 6-month follow up Glasgow Outcome Scale-Extended ≥ 5 in patients with isolated traumatic brain injury (92.3% vs. 79.1%; aIRR 1.2, 95% CI 1 to 1.3).
No significant difference in the rate of functional outcome at 6-month follow up Glasgow Outcome Scale-Extended ≥ 5 (86.5% vs. 77.5%; aIRR 1.1, 95% CI 0.9 to 1.2).
Safety outcomes
No significant difference in good functional outcome at discharge in patients with severe traumatic brain injury and isolated severe traumatic brain injury.
Conclusion
In adult patients with a severe traumatic brain injury, intracranial Abbreviated Injury Scale ≥ 3, β-blocker therapy positive was not superior to β-blocker therapy negative with respect to death in the hospital.
Reference
Hosseinali Khalili, Rebecka Ahl, Shahram Paydar et al. Beta-Blocker Therapy in Severe Traumatic Brain Injury: A Prospective Randomized Controlled Trial. World J Surg. 2020 Jun;44(6):1844-1853.
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