Trial | NCT00810940  Report issue

Title

Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury
Phase 1/2 Multicenter, Randomized, Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    30
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.
Study Started
Oct 31
2010
Primary Completion
Dec 31
2011
Anticipated
Study Completion
Dec 31
2011
Anticipated
Last Update
Dec 08
2010
Estimate

Drug AbelaDrug200

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

Drug mannitol

mannitol plus standard treatment

1 Active Comparator

Control: Standard treatment for severe head trauma including mannitol

2 Experimental

Study drug plus standard treatment

Criteria 

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
No Results Posted