Dexanabinol in Severe Traumatic Brain Injury

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Each year a large number of patients are hospitalized at Shock Trauma Centers with severe head injuries. Bleeding into and swelling of these patients' brains may cause compression of vital structures, disability and death. Sometimes surgery is needed. Unfortunately, the investigators have no medication to treat the bad effects of head trauma. Part of the brain damage is due to toxic chemicals (including one called glutamate) that are released by the damaged nerves. Dexanabinol may prevent some of the bad effects of glutamate on the brain and may protect the brain against uncontrollable swelling and death.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmos
• Treatments: Dronabinol; HU 211

Criteria

Inclusion Criteria:

• Traumatic head injury within the last 6 hours

• Glasgow Coma Motor score of 2 to 5; severity requires intracranial pressure (ICP) monitoring

• Brain computed tomography (CT) showing intracranial parenchymal abnormality and hemodynamically stable

• An informed consent

Exclusion Criteria:

• Penetrating head injury

• Spinal cord injury

• Coma due to pure epidural hematoma with initial Glasgow Coma Scale (GCS) of => 12

• Previous major cerebral damage

• Concomitant severe conditions