NCT00810940

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2008

Completed
1.8 years until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 8, 2010

Status Verified

December 1, 2010

Enrollment Period

1.2 years

First QC Date

December 16, 2008

Last Update Submit

December 6, 2010

Conditions

Severe Head Trauma

Keywords

TBIclosed head injurysevere head traumatraumatic brain injury

Outcome Measures

Primary Outcomes (1)

  • reduction in intracranial pressure

    24 hours, 5 days

Secondary Outcomes (2)

  • mortality

    3 months

  • Glasgow Outcome Scale

    3 months

Study Arms (2)

1

ACTIVE COMPARATOR

Control: Standard treatment for severe head trauma including mannitol

Drug: mannitol

2

EXPERIMENTAL

Study drug plus standard treatment

Drug: AbelaDrug200

Interventions

AbelaDrug200DRUG

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

2
mannitolDRUG

mannitol plus standard treatment

1

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis TBI
  • GCS 4-8
  • Age 16-70

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California, Irvine

Irvine, California, 92868, United States

RECRUITING

Boston University Medical Center

Boston, Massachusetts, 02118, United States

ACTIVE NOT RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Craniocerebral TraumaHead Injuries, ClosedBrain Injuries, Traumatic

Interventions

Mannitol

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesWounds, NonpenetratingBrain InjuriesBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 16, 2008

First Posted

December 18, 2008

Study Start

October 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 8, 2010

Record last verified: 2010-12

Locations

US(3)