SELETHERM 1.2
Research type
Research Study
Full title
Selective brain temperature management after Traumatic Brain Injury - SELETHERM - Clinical investigation protocol
IRAS ID
248587
Contact name
Andrea Lavinio
Contact email
Sponsor organisation
Cambridge University Hospital
Duration of Study in the UK
0 years, 3 months, 4 days
Research summary
In emergency situations such as after a traumatic head injury it is important to control brain temperature, as fever can lead to more severe brain damages, permanent disability and higher healthcare costs.
The aim of the study is to study a new approach to brain temperature management: instead of the total body cooling strategy currently used, that is associated with whole body side effects, we want to target as selectively as possible the brain by modifying the temperature of the surface of the neck. This approach has the potential of significantly reducing side effects.
For this initial study a total of 10 patients will be included. The patients eligible are those admitted to the Neuro-Intensive-Care Unit of the Addenbrooke's Hospital in Cambridge after a traumatic head injury or neurosurgery.
Patients would be divided into two groups: one, the control group, undergoes the standard treatment as far as temperature management is concerned, the other, the study group, receives an additional cooling treatment, targeted to the neck.
We will monitor the temperature of the brain (a standard of care procedure for these patients) and check if the neck approach can keep the brain at the desired temperature without resorting to whole body treatments.
The study treatment will last 24 hours.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
19/EE/0001
Date of REC Opinion
9 Jan 2019
REC opinion
Further Information Favourable Opinion