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Biomarkers of Traumatic Brain Injury With Tbit System

2019-10-03 07:54:46 | BioPortfolio

Summary

A prospective, multi-center, non-randomized, pivotal study to assess the safety and efficacy of the Tbit™ System to aid in patient evaluation, suspected of traumatic brain injury, as adjunct companion test to radiologic standard of care, Cranial Computerized Tomography (CCT).

Study Design

Conditions

Brain Injuries, Traumatic

Intervention

Tbit system

Status

Not yet recruiting

Source

BioDirection Inc

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-03T07:54:46-0400

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Medical and Biotech [MESH] Definitions

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

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.

Traumatic injuries to the cranium where the integrity of the skull is not compromised and no bone fragments or other objects penetrate the skull and dura mater. This frequently results in mechanical injury being transmitted to intracranial structures which may produce traumatic brain injuries, hemorrhage, or cranial nerve injury. (From Rowland, Merritt's Textbook of Neurology, 9th ed, p417)

A form of acquired brain injury which occurs when a sudden trauma causes damage to the brain.

Bleeding within the SKULL induced by penetrating and nonpenetrating traumatic injuries, including hemorrhages into the tissues of CEREBRUM; BRAIN STEM; and CEREBELLUM; as well as into the epidural, subdural and subarachnoid spaces of the MENINGES.

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