Trial Description

When fever is present in patients with stroke, traumatic brain injury (TBI), or brain hemorrhage, it has been associated with worse outcomes including larger areas of tissue death, increased length of stay, worse degree of coma, lower ability to function, and higher mortality. Both adult and pediatric TBI national guidelines state that maintenance of normal body temperature should be a standard of care. However, no further standards or options are presented to specifically guide practice. The current ischemic stroke guidelines state that fever should be treated with fever-reducing agents and offer "cooling devices" as an option but do not provide specifics to guide practice. Over 50% of patients in the Neurosurgical Intensive Care Unit (ICU) at Harborview Medical Center develop fever during the course of their stay. With elevated temperatures the body consumes more oxygen than if the temperature was normal, causing less oxygen to be available to the brain. This may lead to injury of the brain cells and a diminished capacity for healing. Thus, temperature management in neurologically vulnerable patients is both a prevalent and problematic challenge. Based on this information the goal of the present proposal is to evaluate if 1) A standardized, step-wise approach to temperature management using a Normothermia Protocol is successful in achieving and maintaining normal temperature in Neurosurgical ICU patients; and 2) If maintenance of normal temperature will be associated with fewer episodes of diminished responsiveness in their neurological exams as evidenced by a measure of depth of coma, as measured by the Glasgow Coma Score (GCS) compared to a control group treated according to usual care.

Trial Stopped: Practice change created contamination of usual care arm

Conditions

• Subarachnoid Hemorrhage
• Severe Traumatic Brain Injury

Interventions

• Acetaminophen (Tylenol)Drug

  Intervention Desc:	APAP 650mg q4h prn; RTC dosing
  ARM 1:	Kind: Experimental
  	Label: 2
  	Description: Normothermia Protocol

• Aspirin Drug

  Intervention Desc:	Antiplatelet agent; inhibits thromboxane A2; antipyretic

• Standard Medical Care Procedure

  Intervention Desc:	per the National Guidelines for Stroke.

• Ibuprofen (Motrin, Advil,Nurofen )Drug

  Intervention Desc:	Ibuprofen 600mg q6h
  ARM 1:	Kind: Experimental
  	Label: 2
  	Description: Normothermia Protocol

• Physical Cooling Measures Other

  Intervention Desc:	Fan, Ice Packs
  ARM 1:	Kind: Experimental
  	Label: 2
  	Description: Normothermia Protocol

• Cooling blanket Device

  Other Names:	Gaymar Rap'r Round
  Intervention Desc:	Water Circulating Cooling Blanket
  ARM 1:	Kind: Experimental
  	Label: 2
  	Description: Normothermia Protocol

• Hydrogel Cooling Pads Device

  Other Names:	Arctic Sun
  Intervention Desc:	Application to torso and extremities
  ARM 1:	Kind: Experimental
  	Label: 2
  	Description: Normothermia Protocol

• Usual care Other

  Intervention Desc:	Care per attending physician discretion for fever management
  ARM 1:	Kind: Experimental
  	Label: 1
  	Description: Usual Care

Trial Design

• Allocation: Randomized
• Masking: Open Label
• Purpose: Treatment
• Endpoint: Efficacy Study
• Intervention: Parallel Assignment

Patient Involvement

Patient will be randomized to one of two arms: Usual standard of care per their physician or the experimental arm receiving A standardized, step-wise approach to temperature management using a Normothermia Protocol.

Sponsors

• University of Washington Lead
• Gaymar Industries, Inc.