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

C.R. Bard0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•* Adult patients ><=18 and <<=85 years of age (for patients >80 and <<=85 years of age, the qualifying mRS must be <= 0)
•* Admitted with a primary neurological diagnosis of ischemic stroke (AIS), intracerebral hemorrhage (ICH), or subarachnoid hemorrhage (SAH)
•* Prior to onset of acute symptoms, was considered functionally independent (mRS 0-2)
•* Disease-specific criteria:
•For AIS patients:
•- imaging confirmed diagnosis
•- NIHSS ><= 6 at the time of consideration of enrollment
•For ICH patients:
•- imaging confirmed diagnosis
•- NIHSS ><= 6 at the time of consideration of enrollment
•- GCS ><= 5 at the time of consideration of enrollment
•- ICH volume of 1-60 cc
•For SAH patients:
•- aneurysmal SAH confirmed within 24 hrs of symptom onset
•- admission imaging shows Fisher Grade 2, 3 or 4
•- WFNS Grade II-IV
•- neurological stability within 6-48 hrs of endovascular or surgical procedure (if performed)

•* Fever (>= 38°C) for more than one hour 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 that in the opinion of the investigator suggests poor likelihood of survival to 6 months
•* Is undergoing therapeutic hypothermia therapy
•* Has sustained neurological injury felt to be catastrophic with little chance of recovery or is on comfort measures only
•* Has a skin condition in which the use of the ArcticGel Pads is contraindicated
•* Participation in a concurrent interventional study
•* In the investigator*s opinion is likely to stay in the ICU <= 72 hours
•* Is known to be pregnant
•* fever (>= 38°C) at time of study enrollment

发起方

C.R. Bard