SELETHERM 2 - PILOT
Research type
Research Study
Full title
SELETHERM 2 (pilot) - Targeted Cervical Cooling in Severe Traumatic Brain Injury
IRAS ID
350095
Contact name
Andrea Lavinio
Contact email
Sponsor organisation
Cambridge University Hospitals
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
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.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
25/EE/0162
Date of REC Opinion
23 Oct 2025
REC opinion
Further Information Favourable Opinion