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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
Impact of Fever Prevention in Brain Injured Patients
Secondary ID [1] 0 0
BMD-1111
Universal Trial Number (UTN)
Trial acronym
INTREPID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fever 0 0
Ischemic Stroke 0 0
Intracerebral Hemorrhage 0 0
Subarachnoid Hemorrhage 0 0
Condition category
Condition code
Stroke 0 0 0 0
Ischaemic
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Stroke 0 0 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Fever Burden
Assessment method [1] 0 0
Daily average fever burden (°C-hour)
Timepoint [1] 0 0
Up to 14 days
Secondary outcome [1] 0 0
Primary Neurologic Outcome: Modified Rankin Scale Short-Term
Assessment method [1] 0 0
Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.
Timepoint [1] 0 0
3-months post injury
Secondary outcome [2] 0 0
Other Neurologic Outcomes: NIH Stroke Scale Short-Term
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
3-months post injury
Secondary outcome [3] 0 0
Other Neurologic Outcomes: Barthel Index Short-Term
Assessment method [3] 0 0
Barthel Index is an assessment of functional independence. Scores range from 0 to 100, with lower scores indicating worse outcome.
Timepoint [3] 0 0
3-months post injury
Secondary outcome [4] 0 0
Other Neurologic Outcomes: Glasgow Outcome Scale Extended Short-Term
Assessment method [4] 0 0
Glasgow Outcome Scale assesses functional outcome after acute brain injury. Scores range from 1-8, with lower scores indicating worse outcome.
Timepoint [4] 0 0
3-months post injury
Secondary outcome [5] 0 0
Other Neurologic Outcomes: Montreal Cognitive Assessment Short-Term
Assessment method [5] 0 0
Montreal Cognitive Assessment assesses for cognitive impairment. Scores range from 0-30, with lower scores indicating worse outcome.
Timepoint [5] 0 0
3-months post injury
Secondary outcome [6] 0 0
Primary Neurologic Outcome: Modified Rankin Scale Mid-Term
Assessment method [6] 0 0
Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.
Timepoint [6] 0 0
6-months post injury
Secondary outcome [7] 0 0
Other Neurologic Outcomes: NIH Stroke Scale Mid-Term
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
6-months post injury
Secondary outcome [8] 0 0
Other Neurologic Outcomes: Barthel Index Mid-Term
Assessment method [8] 0 0
Barthel Index is an assessment of functional independence. Scores range from 0 to 100, with lower scores indicating worse outcome.
Timepoint [8] 0 0
6-months post injury
Secondary outcome [9] 0 0
Other Neurologic Outcomes: Glasgow Outcome Scale Extended Mid-Term
Assessment method [9] 0 0
Glasgow Outcome Scale assesses functional outcome after acute brain injury. Scores range from 1-8, with lower scores indicating worse outcome.
Timepoint [9] 0 0
6-months post injury
Secondary outcome [10] 0 0
Other Neurologic Outcomes: Montreal Cognitive Assessment Mid-Term
Assessment method [10] 0 0
Montreal Cognitive Assessment assesses for cognitive impairment. Scores range from 0-30, with lower scores indicating worse outcome.
Timepoint [10] 0 0
6-months post injury
Secondary outcome [11] 0 0
Primary Neurologic Outcome: Modified Rankin Scale Long-Term
Assessment method [11] 0 0
Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.
Timepoint [11] 0 0
12-months post injury
Secondary outcome [12] 0 0
Adverse Events
Assessment method [12] 0 0
An untoward medical occurrence, unintended disease or injury, or unanticipated complication
Timepoint [12] 0 0
From date of randomization until hospital discharge, assessed up to 30 days
Secondary outcome [13] 0 0
Major Adverse Events
Assessment method [13] 0 0
MAEs defined as one of the following: pneumonia, sepsis, malignant cerebral edema, death
Timepoint [13] 0 0
From date of randomization until end of study, assessed up to 12 months
Secondary outcome [14] 0 0
Number of Participants With Infection
Assessment method [14] 0 0
Healthcare associated infection
Timepoint [14] 0 0
From date of randomization until hospital discharge, assessed up to 30 days
Secondary outcome [15] 0 0
Number of Subjects With Shivering
Assessment method [15] 0 0
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.
Timepoint [15] 0 0
Up to 14 days

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
Minimum age
21 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/05/2022
Sample size
Target
Accrual to date
Final
686
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
2065 - Sydney
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Mexico
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Rhode Island
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
Austria
State/province [22] 0 0
Innsbruck
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Dresden
Country [25] 0 0
Germany
State/province [25] 0 0
Jena
Country [26] 0 0
Germany
State/province [26] 0 0
Munich
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Daegu
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Seoul
Country [29] 0 0
Switzerland
State/province [29] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
C. R. Bard
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Yale University
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Boston University
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David M. Greer, MD, MA
Address 0 0
Boston University
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02996266