Controlled Trial of ABELADRUG200 in Closed, Severe Head Injury

Abela Pharmaceuticals, Inc.30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Severe Head Trauma

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

mannitolDRUG

mannitol plus standard treatment

Eligibility

Sex: ALLMin age: 16 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (3)

University of California, Irvine

Irvine, California, United States

RECRUITING

Boston University Medical Center

Boston, Massachusetts, United States

ACTIVE_NOT_RECRUITING

Ohio State University

Columbus, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

reduction in intracranial pressure

Time frame: 24 hours, 5 days

Secondary Outcomes

mortality

Time frame: 3 months

Glasgow Outcome Scale

Time frame: 3 months

Data from ClinicalTrials.gov

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