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Transnasal Induction of Normothermia in Febrile Stroke Patients | Clinical Trials | Clareo Health

COMPLETEDNA

Transnasal Induction of Normothermia in Febrile Stroke Patients

NCT03360656•CoolTech LLC

Summary

The objective of this study is to evaluate safety and performance of the COOLSTAT® Transnasal Thermal Regulating Device in reducing temperature in a population of febrile subjects who meet the inclusion/exclusion criteria.

Eligibility

Age

18 - 95 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Admitted to the Neurosciences Critical Care Unit (NCCU).
•2. Patient has ischemic or hemorrhagic stroke, seizure, or metabolic encephalopathy.
•3. Patient is orally intubated or has tracheostomy tube and is mechanically ventilated.
•4. Planned stay in NCCU \> 24 hours.
•5. Must have informed consent from the patient or the legally authorized representative (LAR)

Exclusion Criteria

•1. Age \< 18 years old or \> 95 years.
•2. Intubation is contraindicated.
•3. With a coagulopathy. INR above 1.5 or PTT above 45 seconds.
•4. Hemodynamic instability, including elevated SPB for \>5 minutes despite standard of care interventions (SPB ≥ 160 mmHg for intracerebral hemorrhagic stroke; SPB ≥ 220 mmHg for subarachnoid hemorrhagic stroke or ischemic stroke).
•5. History of cryoglobulinemia.
•6. History of sickle cell disease.
•7. History of serum cold agglutinin disease.
•8. Active/ongoing of nose bleeds.
•9. Known or suspected pregnancy.
•10. Participation in another ongoing investigational study.
+14 more criteria

Locations (3)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

University of Texas, Houston

Houston, Texas, United States

Key Dates

Start Date

January 16, 2018

Primary Completion Date

April 22, 2022

Completion Date

April 22, 2022

Last Updated

June 18, 2023

Enrollment

ACTUAL participants

Conditions

Stroke, IschemicStroke HemorrhagicFeverSeizuresMetabolic Encephalopathy

Interventions

Transnasal Thermal Regulating Device

DEVICE

Rapid Evacuation and Access of Cerebral Hemorrhage Trial

NCT06870812

Stroke Hemorrhagic

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RECRUITINGNA

The Fourth Left Atrial Appendage Occlusion Study

NCT05963698

Atrial FibrillationStroke, Ischemic+1 more

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RECRUITINGPHASE3

A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Transnasal Induction of Normothermia in Febrile Stroke Patients

Inclusion Criteria

Exclusion Criteria

Rapid Evacuation and Access of Cerebral Hemorrhage Trial

The Fourth Left Atrial Appendage Occlusion Study

A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population

Utility of CC7 Transfer in Stroke Subtypes

Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke

VAC-SIP-YF (Vaccination- Safety & Immunogenicity During Pregnancy- Yellow Fever)