NCT00170352

Brief Summary

The purpose of this study is to study the effects of EARLY (no more than 24 four hours from injury) administration of extra amounts of oxygen on traumatic brain injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 1, 2002

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

August 28, 2015

Status Verified

August 1, 2015

Enrollment Period

5 years

First QC Date

September 12, 2005

Last Update Submit

August 27, 2015

Conditions

Traumatic Brain Injury

Keywords

hyperbaric oxygencerebral metabolismhyperoxiatraumatic brain injury

Outcome Measures

Primary Outcomes (4)

  • Cerebral Metabolic Rate of Oxygen (CMRO2)

  • Microdialysis Lactate

  • Brain tissue oxygen (PtO2)

  • Intracranial Pressure (ICP)

Secondary Outcomes (6)

  • Microdialysis-Glycerol,Glucose,Pyruvate,Lactate/Pyruvate Ratio

  • Cerebral Spinal Fluid (CSF) Lactate

  • Arterial-Venous Oxygen Difference (AVDO2)

  • Cerebral Blood Flow (CBF)

  • Cerebral Spinal Fluid Isoprostane

  • +1 more secondary outcomes

Interventions

Hyperbaric Oxygen Treatment (HBOT)PROCEDURE
Enhanced Oxygen Treatment (Enhanced FiO2)PROCEDURE

Eligibility Criteria

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

You may qualify if:

  • All closed head trauma victims with GCS score \< 8, when no effects from paralytics, sedation, alcohol and/or street drugs are present.
  • Informed consent obtained.
  • Entry into the study within 24 hours after injury.
  • If a patient enters the hospital with a mild or moderate brain injury and subsequently deteriorates to a GCS \< 8 within 48 hours of admission, the patient is considered a candidate for entry into the study.
  • CT scan score \> II in accordance with the classification system of the Traumatic Coma Data Bank.

You may not qualify if:

  • Consent could not be obtained.
  • Patients who are brain dead or close to brain death (fixed, dilated pupils).
  • Unstable pulmonary status requiring FiO2 of 50% or greater to maintain a PaO2 of 70 mm Hg or greater.
  • History of severe pulmonary disease, such as COPD or asthma.
  • Unstable fracture (spine, pelvis, femur, etc) preventing placement into the HBO chamber.
  • Patients placed in barbiturate coma during initial management due to the potential effect barbiturates have on cerebral metabolism.
  • Age range \< 16 years or \> 65 years.
  • Coagulopathy.
  • Pregnancy.
  • Severe mental retardation or prior severe head injury.
  • High velocity penetrating injury to the head,(e.g. gunshot wound).
  • Multiple organ failure.
  • Massive cerebral hemisphere or brainstem hematoma, stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Related Publications (1)

  • Rockswold SB, Rockswold GL, Zaun DA, Liu J. A prospective, randomized Phase II clinical trial to evaluate the effect of combined hyperbaric and normobaric hyperoxia on cerebral metabolism, intracranial pressure, oxygen toxicity, and clinical outcome in severe traumatic brain injury. J Neurosurg. 2013 Jun;118(6):1317-28. doi: 10.3171/2013.2.JNS121468. Epub 2013 Mar 19.

    PMID: 23510092DERIVED

MeSH Terms

Conditions

Brain Injuries, TraumaticHyperoxia

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gaylan L Rockswold, M.D., PhD

    Hennepin County Medical Center, Minneapolis

    PRINCIPAL INVESTIGATOR

  • Sarah B Rockswold, M.D.

    Hennepin County Medical Center, Minneapolis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

November 1, 2002

Primary Completion

November 1, 2007

Study Completion

November 1, 2008

Last Updated

August 28, 2015

Record last verified: 2015-08

Locations

US(1)