Safety of Dexmedetomidine in Severe Traumatic Brain Injury

• Status: Withdrawn
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to assess the safety and feasibility of dexmedetomidine as an adjunct to conventional sedative therapy compared to conventional sedative therapy alone in patients with severe traumatic brain injury.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborators: Hospira, Inc.; Hospira, now a wholly owned subsidiary of Pfizer
• Treatments: Dexmedetomidine; Fentanyl; Propofol

Criteria

Inclusion Criteria:

• Diagnosis of severe traumatic brain injury, as defined by AIS score >2 for the head.

• Glasgow Coma Score (GCS) <9 on admission, or deterioration of GCS to <9 within 48 hours of admission due to traumatic brain injury.

• Placement of an intracranial pressure (ICP) monitor or intraventricular catheter (IVC) at the discretion of the Neurosurgical staff as part of standard of care.

• Patient is between 18 and 80 years of age, inclusive.

Exclusion Criteria:

• A body region, other than the brain, with an AIS score >2, or multiple system injury at the investigator's discretion.

• Glasgow Coma Score (GCS) >8 on admission or no decrease of GCS to <9 within 48 hours of admission.

• Placement of an ICP monitor or IVC not clinically indicated by Neurosurgical staff.

• Patient is under the age of 18, or over the age of 80.

• Determination of non-survivability due to the severity of brain injury.

• Non-English speaking, consentable LAR, or patient is non-English speaking.

• Patient is pregnant.

• Unable to obtain consent from a legally authorized representative (LAR).

• Patient is a prisoner, on parole or probation.