POLAR
Trial question
What is the effect of early sustained prophylactic hypothermia among patients with severe traumatic brain injury?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
20.0% female
80.0% male
N = 500
500 patients (99 female, 401 male).
Inclusion criteria: patients both out-of-hospital and in emergency departments after severe traumatic brain injury.
Key exclusion criteria: significant bleeding suggested by systolic hypotension or sustained tachycardia, possible uncontrolled bleeding, GCS score of 3 and unreactive pupils.
Interventions
N=266 hypothermia (targeting a core temperature of 33°C or 35°C if bleeding concerns persist).
N=245 normothermia (the temperature target of 37 +- 0.5 degree Celsius).
Primary outcome
Favorable neurologic outcome, Glasgow Outcome Scale-Extended score of 5-8, at 6 months
48.8%
49.1%
49.1 %
36.8 %
24.6 %
12.3 %
0.0 %
Hypothermia
Normothermia
No significant
difference ↔
No significant difference in favorable neurologic outcome, Glasgow Outcome Scale-Extended score of 5-8, at 6 months (48.8% vs. 49.1%; RR 0.99, 99% CI 0.82 to 1.19).
Secondary outcomes
No significant difference in death in the hospital (20% vs. 18%; RR 1.11, 95% CI 0.77 to 1.6).
No significant difference in death at 6 months (21.1% vs. 18.4%; RR 1.15, 95% CI 0.8 to 1.64).
No significant difference in new or worsening intracranial bleeding (18.1% vs. 15.4%; RR 1.23, 95% CI 0.43 to 3.5).
Safety outcomes
No significant differences in bacteremia, pneumonia, new significant extracranial bleeding.
Conclusion
In patients both out-of-hospital and in emergency departments after severe traumatic brain injury, hypothermia was not superior to normothermia with respect to favorable neurologic outcome, Glasgow Outcome Scale-Extended score of 5-8, at 6 months.
Reference
D James Cooper, Alistair D Nichol, Michael Bailey et al. Effect of Early Sustained Prophylactic Hypothermia on Neurologic Outcomes Among Patients With Severe Traumatic Brain Injury: The POLAR Randomized Clinical Trial. JAMA. 2018 Dec 4;320(21):2211-2220.
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