Impact of Fever Prevention in Brain Injured Patients | NCT02996266

NCT02996266

Status Module

Sponsor/Collaborators Module

Name	Class
Yale University	OTHER
Boston University	OTHER

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fever Prevention	Experimental	Fever will be prevented using a surface targeted temperature management system	Device: Targeted Temperature Management
Standard Care	Active Comparator	Standard care in which fever may spontaneously develop	Other: Standard Care

Name	Type	Description	Arm Group Labels	Other Names
Targeted Temperature Management	Device	Prophylactic normothermia	Fever Prevention

Outcomes Module

Measure	Description	Time Frame
Fever Burden	Daily average fever burden (°C-hour)	Up to 14 days

Secondary Outcomes

Measure	Description	Time Frame
Primary Neurologic Outcome: Modified Rankin Scale Short-Term	Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.	3-months post injury
Other Neurologic Outcomes: NIH Stroke Scale Short-Term

Other Outcomes

Measure	Description	Time Frame
Hospital Length of Stay	Overall hospitalization duration	From date of randomization until hospital discharge, assessed up to 90 days
ICU Length of Stay	ICU Duration

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
David M. Greer, MD, MA	Boston University	Principal Investigator
Kevin N. Sheth, MD	Yale University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Southern California		Los Angeles	California	90033	United States
Stanford University Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39320879	Derived	Greer DM, Helbok R, Badjatia N, Ko SB, Guanci MM, Sheth KN; INTREPID Study Group. Fever Prevention in Patients With Acute Vascular Brain Injury: The INTREPID Randomized Clinical Trial. JAMA. 2024 Nov 12;332(18):1525-1534. doi: 10.1001/jama.2024.14745.
33761119	Derived	Greer DM, Ritter J, Helbok R, Badjatia N, Ko SB, Guanci M, Sheth KN. Impact of Fever Prevention in Brain-Injured Patients (INTREPID): Study Protocol for a Randomized Controlled Trial. Neurocrit Care. 2021 Oct;35(2):577-589. doi: 10.1007/s12028-021-01208-1. Epub 2021 Mar 24.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Fever Prevention	Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia
FG001	Standard Care

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 9, 2020	Jul 10, 2023

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Arctic Sun 5000 Temperature Management System

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.

Standard care in which fever may spontaneously develop

Standard Care: No intervention to control temperature unless fever occurs

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Fever Prevention	Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia
BG001	Standard Care	Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0000.37± 0.961 OG0010.73± 1.075

Secondary

Primary Neurologic Outcome: Modified Rankin Scale Short-Term

Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.

Intent to Treat

Posted

Mean

Standard Deviation

mRS score

3-months post injury

ID	Title	Description
OG000	Fever Prevention	Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia
OG001	Standard Care	Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs

Units	Counts
Participants	OG000

Secondary

Other Neurologic Outcomes: NIH Stroke Scale Short-Term

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.

Intent to Treat

Posted

Mean

Standard Deviation

NIHSS Score

3-months post injury

ID	Title	Description
OG000	Fever Prevention	Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia
OG001	Standard Care	Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs

Units	Counts
Participants	OG000

Secondary

Other Neurologic Outcomes: Barthel Index Short-Term

Barthel Index is an assessment of functional independence. Scores range from 0 to 100, with lower scores indicating worse outcome.

Intent to Treat

Posted

Mean

Standard Deviation

Barthel Index Score

3-months post injury

ID	Title	Description
OG000	Fever Prevention	Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia
OG001	Standard Care	Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs

Units	Counts
Participants	OG000

Secondary

Other Neurologic Outcomes: Glasgow Outcome Scale Extended Short-Term

Glasgow Outcome Scale assesses functional outcome after acute brain injury. Scores range from 1-8, with lower scores indicating worse outcome.

Intent to Treat

Posted

Mean

Standard Deviation

Glasgow Outcome Scale Extended Score

3-months post injury

ID	Title	Description
OG000	Fever Prevention	Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia
OG001	Standard Care	Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs

Units	Counts
Participants	OG000

Secondary

Other Neurologic Outcomes: Montreal Cognitive Assessment Short-Term

Montreal Cognitive Assessment assesses for cognitive impairment. Scores range from 0-30, with lower scores indicating worse outcome.

Intent to Treat

Posted

Mean

Standard Deviation

MOCA Score

3-months post injury

ID	Title	Description
OG000	Fever Prevention	Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia
OG001	Standard Care	Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs

Units	Counts
Participants	OG000

Secondary

Primary Neurologic Outcome: Modified Rankin Scale Mid-Term

Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.

Intent to Treat

Posted

Mean

Standard Deviation

mRS score

6-months post injury

ID	Title	Description
OG000	Fever Prevention	Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia
OG001	Standard Care	Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs

Units	Counts
Participants	OG000

Secondary

Other Neurologic Outcomes: NIH Stroke Scale Mid-Term

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.

Intent to Treat

Posted

Mean

Standard Deviation

NIHSS Score

6-months post injury

ID	Title	Description
OG000	Fever Prevention	Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia
OG001	Standard Care	Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs

Units	Counts
Participants	OG000

Secondary

Other Neurologic Outcomes: Barthel Index Mid-Term

Barthel Index is an assessment of functional independence. Scores range from 0 to 100, with lower scores indicating worse outcome.

Intent to Treat

Posted

Mean

Standard Deviation

Barthel Index Score

6-months post injury

ID	Title	Description
OG000	Fever Prevention	Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia
OG001	Standard Care	Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs

Units	Counts
Participants	OG000

Secondary

Other Neurologic Outcomes: Glasgow Outcome Scale Extended Mid-Term

Glasgow Outcome Scale assesses functional outcome after acute brain injury. Scores range from 1-8, with lower scores indicating worse outcome.

Intent to Treat

Posted

Mean

Standard Deviation

Glasgow Outcome Scale Extended Score

6-months post injury

ID	Title	Description
OG000	Fever Prevention	Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia
OG001	Standard Care	Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs

Units	Counts
Participants	OG000

Secondary

Other Neurologic Outcomes: Montreal Cognitive Assessment Mid-Term

Montreal Cognitive Assessment assesses for cognitive impairment. Scores range from 0-30, with lower scores indicating worse outcome.

Intent to Treat

Posted

Mean

Standard Deviation

MOCA Score

6-months post injury

ID	Title	Description
OG000	Fever Prevention	Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia
OG001	Standard Care	Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs

Units	Counts
Participants	OG000

Secondary

Primary Neurologic Outcome: Modified Rankin Scale Long-Term

Modified Rankin Scale is a 6-category outcome measurement with 0 = no limitations, no symptoms and 6 = death.

Intent to Treat

Posted

Mean

Standard Deviation

mRS score

12-months post injury

ID	Title	Description
OG000	Fever Prevention	Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia
OG001	Standard Care	Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs

Units	Counts
Participants	OG000

Secondary

Adverse Events

An untoward medical occurrence, unintended disease or injury, or unanticipated complication

As Treated

Posted

Number

Adverse Events

From date of randomization until hospital discharge, assessed up to 30 days

ID	Title	Description
OG000	Fever Prevention	Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia
OG001	Standard Care	Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs

Units	Counts
Participants	OG000

Secondary

Major Adverse Events

MAEs defined as one of the following: pneumonia, sepsis, malignant cerebral edema, death

As Treated

Posted

Number

Major Adverse Events

From date of randomization until end of study, assessed up to 12 months

ID	Title	Description
OG000	Fever Prevention	Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia
OG001	Standard Care	Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs

Units	Counts
Participants	OG000

Secondary

Number of Participants With Infection

Healthcare associated infection

As Treated

Posted

Count of Participants

Participants

From date of randomization until hospital discharge, assessed up to 30 days

ID	Title	Description
OG000	Fever Prevention	Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia
OG001	Standard Care	Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs

Units	Counts
Participants	OG000

Secondary

Number of Subjects With Shivering

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.

Intent to Treat

Posted

Count of Participants

Participants

Up to 14 days

ID	Title	Description
OG000	Fever Prevention	Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia
OG001	Standard Care	Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs

Units	Counts
Participants	OG000

Other Pre-specified

Hospital Length of Stay

Overall hospitalization duration

Intent to Treat

Posted

Mean

Standard Deviation

Days

From date of randomization until hospital discharge, assessed up to 90 days

ID	Title	Description
OG000	Fever Prevention	Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia
OG001	Standard Care	Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs

Units	Counts
Participants	OG000

Other Pre-specified

ICU Length of Stay

ICU Duration

Intent to Treat

Posted

Mean

Standard Deviation

Hours

From date of randomization until ICU discharge

ID	Title	Description
OG000	Fever Prevention	Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia
OG001	Standard Care	Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs

Units	Counts
Participants	OG000

Other Pre-specified

Mortality

Intent to Treat

Posted

Count of Participants

Participants

7-day (or hospital discharge); 3-, 6-, and 12-months

ID	Title	Description
OG000	Fever Prevention	Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia
OG001	Standard Care	Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Fever Prevention	Fever will be prevented using a surface targeted temperature management system Targeted Temperature Management: Prophylactic normothermia	75	339	150	331	122	331
EG001	Standard Care	Standard care in which fever may spontaneously develop Standard Care: No intervention to control temperature unless fever occurs	77	338	132	336	48	336

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Brain Oedema	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG00027 affected331 at risk EG00129 affected336 at risk
Pneumonia	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG00045 affected331 at risk EG00148 affected336 at risk
Urinary Tract Infection	Infections and infestations	MedDRA (23.1)	Systematic Assessment	EG00031 affected331 at risk EG0011 affected336 at risk
Cerebral Vasoconstriction	Nervous system disorders	MedDRA (23.1)	Systematic Assessment	EG00026 affected331 at risk EG00126 affected336 at risk
Pneumonia Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Systematic Assessment	EG00037 affected331 at risk EG00128 affected336 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Leukocytosis	Blood and lymphatic system disorders	MedDRA (23.1)	Systematic Assessment	EG00018 affected331 at risk EG0017 affected336 at risk
Chills	General disorders	MedDRA (23.1)	Systematic Assessment	EG00073 affected331 at risk EG0015 affected336 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG00017 affected331 at risk EG00123 affected336 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Systematic Assessment	EG00020 affected331 at risk EG00113 affected336 at risk

ID	Term
D005334	Fever
D000083242	Ischemic Stroke
D002543	Cerebral Hemorrhage
D013345	Subarachnoid Hemorrhage

Ancestor Terms

ID	Term
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D020300	Intracranial Hemorrhages
D006470	Hemorrhage
D010335	Pathologic Processes

ID	Term
D007036	Hypothermia, Induced
D059039	Standard of Care

Ancestor Terms

ID	Term
D017679	Cryotherapy
D013812	Therapeutics
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation