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Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury

NCT ID: NCT00810940

Last Updated: 2010-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Severe Head Trauma

Keywords

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TBI closed head injury severe head trauma traumatic brain injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Control: Standard treatment for severe head trauma including mannitol

Group Type ACTIVE_COMPARATOR

mannitol

Intervention Type DRUG

mannitol plus standard treatment

2

Study drug plus standard treatment

Group Type EXPERIMENTAL

AbelaDrug200

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

mannitol

mannitol plus standard treatment

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University

OTHER

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role collaborator

Dr. Mahajan's Hospital & Industrial Trauma Centre

OTHER

Sponsor Role collaborator

Abela Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Abela Pharmaceuticals, Inc.

Locations

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University of California, Irvine

Irvine, California, United States

Site Status RECRUITING

Boston University Medical Center

Boston, Massachusetts, United States

Site Status ACTIVE_NOT_RECRUITING

Ohio State University

Columbus, Ohio, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Michael Lekawa, MD

Role: primary

John McGregor, MD

Role: primary

Other Identifiers

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AbelaTBI2

Identifier Type: -

Identifier Source: org_study_id