Impact of Fever Prevention in Brain Injured Patients (INTREPID)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02996266 |
Recruitment Status :
Recruiting
First Posted : December 19, 2016
Last Update Posted : November 12, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fever Ischemic Stroke Intracerebral Hemorrhage Subarachnoid Hemorrhage | Device: Targeted Temperature Management Other: Standard Care | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1176 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Impact of Fever Prevention in Brain Injured Patients |
Study Start Date : | January 2017 |
Estimated Primary Completion Date : | February 2021 |
Estimated Study Completion Date : | December 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Fever Prevention
Fever will be prevented using a surface targeted temperature management system
|
Device: Targeted Temperature Management
Prophylactic normothermia
Other Name: Arctic Sun 5000 Temperature Management System |
Active Comparator: Standard Care
Standard care in which fever may spontaneously develop
|
Other: Standard Care
No intervention to control temperature unless fever occurs |
- Fever Burden [ Time Frame: Up to 14 days ]Daily average fever burden (°C-hour)
- Primary Neurologic Outcome: Short-Term [ Time Frame: 3-months post injury ]Modified Rankin Scale
- Other Neurologic Outcomes: NIH Stroke Scale Short-Term [ Time Frame: 3-months post injury ]NIH Stroke Scale
- Other Neurologic Outcomes: Barthel Index Short-Term [ Time Frame: 3-months post injury ]Barthel Index
- Other Neurologic Outcomes: Glasgow Outcome Scale Short-Term [ Time Frame: 3-months post injury ]Glasgow Outcome Scale
- Other Neurologic Outcomes: Montreal Cognitive Assessment Short-Term [ Time Frame: 3-months post injury ]Montreal Cognitive Assessment
- Primary Neurologic Outcome: Mid-Term [ Time Frame: 6-months post injury ]Modified Rankin Scale
- Other Neurologic Outcomes: NIH Stroke Scale Mid-Term [ Time Frame: 6-months post injury ]NIH Stroke Scale
- Other Neurologic Outcomes: Barthel Index Mid-Term [ Time Frame: 6-months post injury ]Barthel Index
- Other Neurologic Outcomes: Glasgow Outcome Scale Mid-Term [ Time Frame: 6-months post injury ]Glasgow Outcome Scale
- Other Neurologic Outcomes: Montreal Cognitive Assessment Mid-Term [ Time Frame: 6-months post injury ]Montreal Cognitive Assessment
- Primary Neurologic Outcome: Long-Term [ Time Frame: 12-months post injury ]Modified Rankin Scale
- Adverse Events [ Time Frame: From date of randomization until hospital discharge, assessed up to 30 days ]An untoward medical occurrence, unintended disease or injury, or unanticipated complication
- Infection Rate [ Time Frame: From date of randomization until hospital discharge, assessed up to 30 days ]Healthcare associated infection
- Incidence of Shivering [ Time Frame: Up to 14 days ]Shivering greater than or equal to 1 on the Bedside Shivering Assessment Scale
- Length of Stay [ Time Frame: From date of randomization until hospital discharge, assessed up to 90 days ]ICU and overall hospital length of stay
- Mortality [ Time Frame: 7-day (or hospital discharge); 3-, 6-, and 12-months ]Mortality

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Admitted with a primary neurological diagnosis of ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage
- Prior to onset of acute symptoms, was considered functionally independent (mRS 0-2)
- Meets disease-specific criteria
Exclusion Criteria:
- Fever (≥38°C) prior to study enrollment
- 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
- Has a pre-morbid condition with poor likelihood of survival to 6 months
- Has a pre-morbid mRS ≥3
- Diagnosed with brain death
- Is undergoing therapeutic hypothermia therapy
- Has sustained neurological injury felt to be catastrophic with little chance of recovery
- 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)
- Has poor skin integrity or poor tissue perfusion
- Participation in a concurrent investigational / interventional study (medical device or drug)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996266
Contact: Peter Fayek | (847) 362-8796 | peter.fayek@bd.com |

Principal Investigator: | David M. Greer, MD, MA | Boston University | |
Principal Investigator: | Kevin N. Sheth, MD | Yale University |
Responsible Party: | C. R. Bard |
ClinicalTrials.gov Identifier: | NCT02996266 |
Other Study ID Numbers: |
BMD-1111 |
First Posted: | December 19, 2016 Key Record Dates |
Last Update Posted: | November 12, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Targeted Temperature Management |
Subarachnoid Hemorrhage Cerebral Hemorrhage Hemorrhage Fever Pathologic Processes Body Temperature Changes Intracranial Hemorrhages |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |