In patients with severe traumatic brain injury (TBI), controlling brain temperature is essential because elevated brain temperature (fever) is associated with worse brain damage, long-term disability, and higher healthcare costs. Current methods for reducing brain temperature involve whole-body cooling techniques like cooling blankets or intravascular devices, but these can lead to significant side effects and may not efficiently target the brain itself.

This study aims to test a new, more focused approach to managing brain temperature.

We will evaluate a specially designed cooling collar around the neck, which targets the brain more directly. This targeted method has the potential to lower brain temperature effectively while reducing the side effects associated with whole-body cooling and could also help lower healthcare costs.

Throughout the study, we will closely monitor brain temperature (a standard procedure in these patients) to determine whether the new neck cooling device can keep the brain temperature at safe levels without needing whole-body cooling. We will also collect blood samples to measure brain damage biomarkers, which can show the level of brain injury and the effectiveness of the treatment.
The cooling treatment will last up to 72 hours. By the end of the study, we hope to demonstrate that this new cooling device can reduce brain fever, minimise side effects, and improve recovery for patients with severe TBI, while also reducing the use of intensive resources. This could lead to a safer, more effective approach to brain temperature management in future treatments.

Regulatory status of the device used in the study:

• Registered with the MHRA as a class IIa medical device and accessories
• CE-marked under MDR as a class IIa medical device and accessories
• Listed by FDA  as a class II medical device and accessories