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Discrete Hypothermia in the Management of Traumatic Brain Injury

2014-08-27 03:30:40 | BioPortfolio

Summary

The primary goal of this project is to demonstrate the feasibility and clinical benefits of a new rapid treatment for secondary treatment for secondary brain injury called Discrete Cerebral Hypothermia System by CoolSystems, Inc., Berkley, CA. This device induced hypothermia in the adult brain without significant whole body hypothermia. Discrete Cerebral Hypothermia System holds a great potential for protecting the brain from the devastating secondary complications of trauma without the associated deleterious system effects.

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Severe Traumatic Brain Injury

Intervention

CoolSystems Discrete Cerebral Hypothermia System

Location

Emory University School of Medicine, Grady Health System campus
Atlanta
Georgia
United States
30303

Status

Active, not recruiting

Source

Emory University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:30:40-0400

Clinical Trials [2488 Associated Clinical Trials listed on BioPortfolio]

Hypothermia in Traumatic Brain Injury in Children (HiTBIC)

The purpose of this study is: - To determine the safety and feasibility of performing an international multi-centre randomized control trial of early and prolonged hypothermia to ...

Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury

Induction of hypothermia to < 35˚C by < 2.5 hours after severe traumatic brain injury, reaching 33˚C by 4 hours after injury and maintained for 48 hours in patients aged 16-45 will resul...

Randomized Controlled Trial of Long-term Mild Hypothermia for Severe Traumatic Brain Injury

This study is a prospective multi-centre randomized trial to compare the effect of long-term mild hypothermia versus routine normothermic intensive management in patients with severe traum...

IHPOTOTAM : Induced HyPOthermia TO Treat Adult Meningitis

Bacterial meningitis is a severe infection of the envelope which surrounds the brain. It is sometimes responsible for a cerebral oedema mattering with a loss of consciousness (coma). The u...

Hypothermia in Children After Trauma

The primary hypothesis for this application for a multicenter phase III randomized clinical trial (RCT) is that induced moderate hypothermia (HYPO) (32-33 °C) after severe traumatic brain...

PubMed Articles [20020 Associated PubMed Articles listed on BioPortfolio]

Early-Onset Ventilator-Associated Pneumonia in Patients with Severe Traumatic Brain Injury: Incidence, Risk Factors, and Consequences in Cerebral Oxygenation and Outcome.

Early-onset ventilator-associated pneumonia (EOVAP) occurs frequently in severe traumatic brain-injured patients, but potential consequences on cerebral oxygenation and outcome have been poorly studie...

Updating Evidence for Using Hypothermia in Pediatric Severe Traumatic Brain Injury: Conventional and Bayesian Meta-Analytic Perspectives.

To evaluate clinical trials of hypothermia management on outcome in pediatric patients with severe traumatic brain injury using conventional and Bayesian meta-analyses.

Updating Evidence for Using Therapeutic Hypothermia in Pediatric Severe Traumatic Brain Injury.

Brain Oxygen Optimization in Severe Traumatic Brain Injury Phase-II: A Phase II Randomized Trial.

A relationship between reduced brain tissue oxygenation and poor outcome following severe traumatic brain injury has been reported in observational studies. We designed a Phase II trial to assess whet...

Severe traumatic brain injury in children: an evidence-based review of emergency department management digest.

More than 1.7 million traumatic brain injuries occur in adults and children each year in the United States, with approximately 30% occurring in children aged < 14 years. Traumatic brain injury is a si...

Medical and Biotech [MESH] Definitions

Bleeding within the brain as a result of penetrating and nonpenetrating CRANIOCEREBRAL TRAUMA. Traumatically induced hemorrhages may occur in any area of the brain, including the CEREBRUM; BRAIN STEM (see BRAIN STEM HEMORRHAGE, TRAUMATIC); and CEREBELLUM.

Radiography of the ventricular system of the brain after injection of air or other contrast medium directly into the cerebral ventricles. It is used also for x-ray computed tomography of the cerebral ventricles.

Acute and chronic (see also BRAIN INJURIES, CHRONIC) injuries to the brain, including the cerebral hemispheres, CEREBELLUM, and BRAIN STEM. Clinical manifestations depend on the nature of injury. Diffuse trauma to the brain is frequently associated with DIFFUSE AXONAL INJURY or COMA, POST-TRAUMATIC. Localized injuries may be associated with NEUROBEHAVIORAL MANIFESTATIONS; HEMIPARESIS, or other focal neurologic deficits.

Prolonged unconsciousness from which the individual cannot be aroused, associated with traumatic injuries to the BRAIN. This may be defined as unconsciousness persisting for 6 hours or longer. Coma results from injury to both cerebral hemispheres or the RETICULAR FORMATION of the BRAIN STEM. Contributing mechanisms include DIFFUSE AXONAL INJURY and BRAIN EDEMA. (From J Neurotrauma 1997 Oct;14(10):699-713)

Traumatic injuries to the brain, cranial nerves, spinal cord, autonomic nervous system, or neuromuscular system, including iatrogenic injuries induced by surgical procedures.

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