INTREPID Study
Research type
Research Study
Full title
Impact of Fever Prevention in Brain Injured Patients (INTREPID)
IRAS ID
227769
Contact name
Gerald Smith
Contact email
Sponsor organisation
Bard Medical Division CR Bard Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 7 months, 30 days
Research summary
The INTREPID study will be the first study to research if preventing fever might improve outcomes for patients with ischemic stroke, intracerebral haemorrhage (ICH)or subarachnoid haemorrhage.
To be included in the study, participants must be between the ages of 21 and 80 years, admitted to hospital with a primary neurological diagnosis of ischemic stroke, intracerebral hemorrhage, or subarachnoid haemorrhage; prior to the onset of acute symptoms was considered functionally independent (score of 0-2 on the Modified Rankin Scale). Additional disease specific criteria would also apply.
Informed consent would be obtained from the participant or legal representative. Once enrolled, participants will be randomised into the Fever Prevention (treatment group) or Standard Care (control group).
The Fever Prevention group will have their temperature managed by the Arctic Sun® 5000 Temperature Management System. The Standard Care group may develop fever spontaneously and would be treated in line with standard medical practice at the hospital, which may include medications and/or ice packs, fans and blankets.
Participants will be monitored closely during the 'acute' phase of the study which covers day 1 to 14 or deemed ready to be discharged from intensive care (whichever is sooner). Participants will be followed up at 5 days, 3 months, 6 months & 12 months post discharge, during which neurological assessments will be performed and Major Adverse Events will be collected.
It is planned to enrol 1,176 patients at up to 40 sites globally including Europe, US, South Korea & Australia.
REC name
North West - Haydock Research Ethics Committee
REC reference
17/NW/0507
Date of REC Opinion
20 Nov 2017
REC opinion
Further Information Favourable Opinion