Impact of Fever Prevention in Brain Injured Patients (INTREPID) - INTREPID

Bard Medical Division C. R. Bard, Inc.0 个研究点目标入组 685 人开始时间: 2018年3月9日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1. Admitted with a primary neurological diagnosis of ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage; and
•2. Prior to onset of acute symptoms, was considered functionally independent (mRS 0-2); and
•3. Meets the disease-specific criteria

•1. Fever (=38.0°C) for more than one hour or one instance prior to study enrollment; or
•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; or
•3. Has a pre-morbid condition with poor likelihood of survival to 6 months; or
•4. Has a pre-morbid mRS =3 for subjects 18 – 80 years of age or =1 for subjects =81 years of age; or
•5. Diagnosed with brain death; or
•6. Is undergoing therapeutic hypothermia therapy; or
•7. Has sustained neurological injury felt to be catastrophic with little chance of recovery or is on comfort measures only; or
•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); or
•9. Has poor skin integrity or poor tissue perfusion; or
•10. Participation in a concurrent investigational / interventional study (medical device or drug); or
•11. In the investigator’s opinion is likely to stay in the ICU =72 hours; or
•12. Is known to be pregnant, or has a positive pregnancy test (for women of childbearing age.
•13. Fever (=38.0°C) at time of study enrollment.

发起方

Bard Medical Division C. R. Bard, Inc.