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San Antonio, Texas 78229


Purpose:

This is a clinical study comparing the physiologic effects of two hypertonic solutions (mannitol, hypertonic saline) with a particular emphasis on changes in cerebral blood flow in patients with intracranial hypertension following serious traumatic brain injury (TBI).


Study summary:

This is a study comparing effects of two hypertonic solutions (mannitol, 6.4% hypertonic saline) on intracranial hypertension, cerebral blood flow, serum/urine osmolarity in patients with increased intracranial pressure caused by traumatic brain injury. The study is conducted during first 72 hours after the injury without any interference with standard medical treatment as performed at the institution. When the hypertonic solution is indicated by caregiver, the study team is informed and performs a set of physiologic bedside measurements including evaluation of cerebral blood flow and changes in plasma and urine osmolarity. The study is noninvasive and the study protocol does not hamper, in any way, standard care of treatment for these patients.


Criteria:

Inclusion Criteria: - Patients with severe TBI (motor Glasgow Coma Scale [GCS] score < 5) - Age > 18 years - Health care provider indicated a treatment of intracranial hypertension using hyperosmotic agent Exclusion Criteria: - Brain dead (GCS 3, fixed dilated pupils) - Life-threatening systemic injuries (AIS > 4 in an organ system other than brain); AIS = Abbreviated Injury Score - Hypotension not responsive to fluid resuscitation and low doses of dopamine - Clinical or imaging sign/suspicion for internal carotid artery injury


NCT ID:

NCT00125229


Primary Contact:

Principal Investigator
Roman Hlatky, M.D.
Center for Neurosurgical Sciences - UTHSC San Antonio

Roman Hlatky, M.D.
Phone: 210-567-5625
Email: hlatky@uthscsa.edu


Backup Contact:

N/A


Location Contact:

San Antonio, Texas 78229
United States

Roman Hlatky, M.D.
Phone: 210-567-5625
Email: hlatky@uthscsa.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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