6/29/23, 1:41 AM POLAR Pathway Feedback Search Clinical Topics Home Studies POLAR POLAR Disease Traumatic brain injury Trial question What is the effect of early sustained prophylactic hypothermia among patients with severe TBI? Study design Multi-center Open label RCT Population Characteristics of study participants 19.6% female N = 511 80.4% male 511 patients (99 female, 401 male) Inclusion criteria: patients both out-of-hospital and in emergency departments after severe TBI Key exclusion criteria: significant bleeding suggested by systolic hypotension or sustained tachycardia, possible uncontrolled bleeding, Glasgow Coma Scale 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 https://web.pathway.md/studies/rec0RdEBTgQLZH5Tc 1/2 6/29/23, 1:41 AM POLAR Pathway 49.1 % 49.1 48.8 36.8 % 24.6 % 12.3 % No significant difference 0.0 % Hypothermia Normothermia 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 TBI, 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. Open reference URL https://web.pathway.md/studies/rec0RdEBTgQLZH5Tc 2/2