NCT00174980

Brief Summary

Brain damage as a result of decreased oxygen to the brain is found in 80% of patients that die with severe head injuries. Laboratory studies in animals and clinical trials have shown that increasing oxygen in the brain results in better brain oxygen consumption, less cell death, and better functional outcome. This study will test the hypothesis that Oxycyte is an effective way to increase brain oxygen levels in severe head injury.

Trial Health

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Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
17.9 years until next milestone

Results Posted

Study results publicly available

February 24, 2026

Completed
Last Updated

February 24, 2026

Status Verified

October 1, 2012

Enrollment Period

2.5 years

First QC Date

September 9, 2005

Results QC Date

October 17, 2016

Last Update Submit

February 4, 2026

Conditions

Traumatic Brain Injury

Keywords

Oxycyteperfluorocarbon oxygen carrierbrain oxygen tension

Outcome Measures

Primary Outcomes (1)

  • Brain Dialysate Concentration Data

    40 hours

Study Arms (1)

Oxycyte, perfluorocarbon

EXPERIMENTAL

one time dose of 3mL/kg over 15 minutes

Drug: Oxycyte

Interventions

OxycyteDRUG

intravenous infusion

Also known as: perfluorocarbon
Oxycyte, perfluorocarbon

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • severe closed head injury patients or GCS 3-9 patients who receive brain oxygen monitoring
  • ventriculostomy/ICP monitor
  • at least one reactive pupil
  • no known life threatening disease prior to trauma
  • age 18-70 years old
  • consent for microdialysis/brain 02 monitoring
  • legal family representative present that can give informed consent for perfluorocarbon administration

You may not qualify if:

  • no motor response
  • both pupils fixed and dilated
  • no consent available
  • allergy to egg proteins
  • coagulopathy
  • major liver injury
  • major pulmonary injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

perfluoro(t-butylcyclohexane)Fluorocarbons

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Hydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsOrganic Chemicals

Limitations and Caveats

This study involved a sample size of just nine patients, with multiple concomitant injuries and medications, results must be regarded as provisional.

Results Point of Contact

Title
Dr. Douglas Hay
Organization
Tenax Therapeutics, Inc
t.bradshaw@oxybiomed.com
919-855-2110

Study Officials

  • M. R Bullock, M.D.

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

September 1, 2005

Primary Completion

March 1, 2008

Study Completion

April 1, 2008

Last Updated

February 24, 2026

Results First Posted

February 24, 2026

Record last verified: 2012-10

Locations

US(1)