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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02996266
Registration number
NCT02996266
Ethics application status
Date submitted
5/12/2016
Date registered
19/12/2016
Date last updated
21/09/2023
Titles & IDs
Public title
Impact of Fever Prevention in Brain Injured Patients
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Scientific title
Impact of Fever Prevention in Brain Injured Patients
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Secondary ID [1]
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BMD-1111
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Universal Trial Number (UTN)
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Trial acronym
INTREPID
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Fever
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Ischemic Stroke
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Intracerebral Hemorrhage
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Subarachnoid Hemorrhage
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0
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Condition category
Condition code
Stroke
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0
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Ischaemic
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Neurological
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Other neurological disorders
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Cardiovascular
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0
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Stroke
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0
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0
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Haemorrhagic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Targeted Temperature Management
Other interventions - Standard Care
Experimental: Fever Prevention - Fever will be prevented using a surface targeted temperature management system
Active Comparator: Standard Care - Standard care in which fever may spontaneously develop
Treatment: Devices: Targeted Temperature Management
Prophylactic normothermia
Other interventions: Standard Care
No intervention to control temperature unless fever occurs
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Fever Burden
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Assessment method [1]
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Daily average fever burden (°C-hour)
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Timepoint [1]
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Up to 14 days
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Secondary outcome [1]
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Primary Neurologic Outcome: Modified Rankin Scale Short-Term
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Assessment method [1]
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Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.
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Timepoint [1]
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3-months post injury
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Secondary outcome [2]
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Other Neurologic Outcomes: NIH Stroke Scale Short-Term
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Assessment method [2]
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NIH Stroke Scale is a systematic, quantitative assessment tool to measure stroke-related neurological deficit. Scores range from 0 to 42, with higher scores indicating worse outcome.
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Timepoint [2]
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3-months post injury
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Secondary outcome [3]
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Other Neurologic Outcomes: Barthel Index Short-Term
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Assessment method [3]
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Barthel Index is an assessment of functional independence. Scores range from 0 to 100, with lower scores indicating worse outcome.
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Timepoint [3]
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3-months post injury
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Secondary outcome [4]
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Other Neurologic Outcomes: Glasgow Outcome Scale Extended Short-Term
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Assessment method [4]
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Glasgow Outcome Scale assesses functional outcome after acute brain injury. Scores range from 1-8, with lower scores indicating worse outcome.
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Timepoint [4]
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3-months post injury
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Secondary outcome [5]
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Other Neurologic Outcomes: Montreal Cognitive Assessment Short-Term
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Assessment method [5]
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Montreal Cognitive Assessment assesses for cognitive impairment. Scores range from 0-30, with lower scores indicating worse outcome.
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Timepoint [5]
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3-months post injury
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Secondary outcome [6]
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Primary Neurologic Outcome: Modified Rankin Scale Mid-Term
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Assessment method [6]
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Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.
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Timepoint [6]
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6-months post injury
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Secondary outcome [7]
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Other Neurologic Outcomes: NIH Stroke Scale Mid-Term
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Assessment method [7]
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NIH Stroke Scale is a systematic, quantitative assessment tool to measure stroke-related neurological deficit. Scores range from 0 to 42, with higher scores indicating worse outcome.
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Timepoint [7]
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6-months post injury
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Secondary outcome [8]
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Other Neurologic Outcomes: Barthel Index Mid-Term
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Assessment method [8]
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Barthel Index is an assessment of functional independence. Scores range from 0 to 100, with lower scores indicating worse outcome.
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Timepoint [8]
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6-months post injury
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Secondary outcome [9]
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Other Neurologic Outcomes: Glasgow Outcome Scale Extended Mid-Term
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Assessment method [9]
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Glasgow Outcome Scale assesses functional outcome after acute brain injury. Scores range from 1-8, with lower scores indicating worse outcome.
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Timepoint [9]
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6-months post injury
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Secondary outcome [10]
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Other Neurologic Outcomes: Montreal Cognitive Assessment Mid-Term
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Assessment method [10]
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Montreal Cognitive Assessment assesses for cognitive impairment. Scores range from 0-30, with lower scores indicating worse outcome.
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Timepoint [10]
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6-months post injury
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Secondary outcome [11]
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Primary Neurologic Outcome: Modified Rankin Scale Long-Term
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Assessment method [11]
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Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.
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Timepoint [11]
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12-months post injury
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Secondary outcome [12]
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Adverse Events
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Assessment method [12]
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An untoward medical occurrence, unintended disease or injury, or unanticipated complication
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Timepoint [12]
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From date of randomization until hospital discharge, assessed up to 30 days
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Secondary outcome [13]
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Major Adverse Events
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Assessment method [13]
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MAEs defined as one of the following: pneumonia, sepsis, malignant cerebral edema, death
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Timepoint [13]
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From date of randomization until end of study, assessed up to 12 months
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Secondary outcome [14]
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Number of Participants With Infection
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Assessment method [14]
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Healthcare associated infection
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Timepoint [14]
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From date of randomization until hospital discharge, assessed up to 30 days
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Secondary outcome [15]
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Number of Subjects With Shivering
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Assessment method [15]
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Shivering greater than or equal to 1 on the Bedside Shivering Assessment Scale (BSAS). BSAS scores range from 0-3 with 0 indicating no shivering noted and 3 indicating severe shivering involving gross movements of the trunk and upper and lower extremities.
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Timepoint [15]
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Up to 14 days
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Eligibility
Key inclusion criteria
1. Admitted with a primary neurological diagnosis of ischemic stroke, intracerebral
hemorrhage, or subarachnoid hemorrhage
2. Prior to onset of acute symptoms, was considered functionally independent (mRS 0-2)
3. Meets disease-specific criteria
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Minimum age
21
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Fever (=38°C) prior to study enrollment
2. Pre-existing neurological, psychiatric, or other condition that would confound
neurological assessment or would make it difficult to accurately assess neurologic
and/or functional outcome
3. Has a pre-morbid condition with poor likelihood of survival to 6 months
4. Has a pre-morbid mRS =3
5. Diagnosed with brain death
6. Is undergoing therapeutic hypothermia therapy
7. Has sustained neurological injury felt to be catastrophic with little chance of
recovery
8. Has a skin condition in which the use of the ArcticGel Pads is contraindicated (i.e.,
skin that has signs of ulceration, burns, hives, or rash)
9. Has poor skin integrity or poor tissue perfusion
10. Participation in a concurrent investigational / interventional study (medical device
or drug)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/05/2022
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Sample size
Target
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Accrual to date
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Final
686
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Recruitment in Australia
Recruitment state(s)
NSW,SA
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Recruitment hospital [1]
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Royal North Shore Hospital - Sydney
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Recruitment hospital [2]
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Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
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2065 - Sydney
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Recruitment postcode(s) [2]
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- Adelaide
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
0
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United States of America
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State/province [2]
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Colorado
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Country [3]
0
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United States of America
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State/province [3]
0
0
Connecticut
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Country [4]
0
0
United States of America
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State/province [4]
0
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Florida
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Illinois
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Kentucky
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Louisiana
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Maryland
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Country [9]
0
0
United States of America
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State/province [9]
0
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Massachusetts
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Country [10]
0
0
United States of America
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State/province [10]
0
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Michigan
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Country [11]
0
0
United States of America
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State/province [11]
0
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Missouri
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Country [12]
0
0
United States of America
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State/province [12]
0
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New Mexico
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Country [13]
0
0
United States of America
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State/province [13]
0
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New York
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Country [14]
0
0
United States of America
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State/province [14]
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North Carolina
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Country [15]
0
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United States of America
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State/province [15]
0
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Ohio
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Country [16]
0
0
United States of America
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State/province [16]
0
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Oregon
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Country [17]
0
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United States of America
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State/province [17]
0
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Pennsylvania
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Country [18]
0
0
United States of America
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State/province [18]
0
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Rhode Island
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Country [19]
0
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United States of America
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State/province [19]
0
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Tennessee
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Country [20]
0
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United States of America
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State/province [20]
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Texas
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Country [21]
0
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United States of America
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State/province [21]
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Washington
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Country [22]
0
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Austria
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State/province [22]
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Innsbruck
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Country [23]
0
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Germany
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State/province [23]
0
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Berlin
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Country [24]
0
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Germany
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State/province [24]
0
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Dresden
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Country [25]
0
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Germany
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State/province [25]
0
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Jena
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Country [26]
0
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Germany
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State/province [26]
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Munich
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Country [27]
0
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Korea, Republic of
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State/province [27]
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Daegu
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Country [28]
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Korea, Republic of
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State/province [28]
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Seoul
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Country [29]
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Switzerland
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State/province [29]
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Zürich
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
C. R. Bard
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Yale University
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Boston University
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will assess the impact of fever prevention on fever burden and short- and
long-term neurologic outcomes in brain injured patients. Half of the subjects will undergo
fever prevention using a targeted temperature management system and half of the subjects will
be treated for fever should it develop.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02996266
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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David M. Greer, MD, MA
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Address
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Boston University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02996266
Download to PDF