CHIC FM
Research type
Research Study
Full title
A pilot Phase II randomised controlled trial in patients with malignant cerebral infarction eligible for surgical intervention to assess the feasibility and safety of local brain temperature reduction and estimate its effect on patient outcomes.
IRAS ID
141603
Contact name
Bartlomiej Maciej Piechowski-Jozwiak
Contact email
Sponsor organisation
King's College Hospital
Research summary
Stroke is the third leading cause of death/disability in developed countries. The risk of severe disability and risk of death is increased in ischaemic stroke caused by occlusion of the middle cerebral artery. In people younger than 60 years, this may cause severe brain swelling and secondary damage of the remaining healthy brain. Therapeutic resection of a part of the skull vault is a life-saving procedure in this situation. Adding mild hypothermia in the perioperative period for these patients may be beneficial firstly by limiting the size of the stroke and secondly it may lead to improved outcomes. This is a randomized study comparing standard craniotomy vs. craniotomy with cooling of the brain through the nose with the RhinoChill Nasal Cooling Device (RNCD). Half of the hypothermia patients will be treated with blanket cooling in the post-operative period. Primary endpoint is the size of the stroke. Secondary endpoints include functional outcomes and survival rates
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
14/EE/0115
Date of REC Opinion
20 Oct 2014
REC opinion
Further Information Favourable Opinion