Severe Head Trauma
Conditions
Keywords
TBI, closed head injury, severe head trauma, traumatic brain injury
Brief summary
This is a randomized, controlled clinical trial at three sites to determine the safety and preliminary efficacy of the study drug to treat severe head trauma (GCS 4-8). It is hypothesized that the drug may lower pressure in the brain, reduce mortality and the patient may have improved neurological function following treatment.
Interventions
DRUGAbelaDrug200
IV 200 ml 28%drug in D5W every six hours, 10 min. duration, until ICP \< 20 mmHg, then IV 100 ml same schedule for 24 hours
DRUGmannitol
mannitol plus standard treatment
Sponsors
Ohio State University
University of California, Irvine
Dr. Mahajan's Hospital & Industrial Trauma Centre
Abela Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis TBI * GCS 4-8 * Age 16-70
Exclusion criteria
* Multiple trauma resulting in shock * Bilateral absent pupil response * Time from injury \> 6 hours * Brain tumor or mass effect secondary to hemorrhage or brain surgery * Pregnancy * Confounding condition or injury * Spinal cord injury * Sustained high blood pressure or arterial oxygen saturation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| reduction in intracranial pressure | 24 hours, 5 days |
Secondary
| Measure | Time frame |
|---|---|
| mortality | 3 months |
| Glasgow Outcome Scale | 3 months |
Countries
United States
Outcome results
None listed