NCT00163774

Brief Summary

Analysis of cerebral blood flow (CBF) and oxygenation using complementary focal and global monitoring techniques will permit the delivery of more informed individualised and 'targeted' therapy on the patient with severe head injury, reduce episodes of secondary brain injury and therefore improve outcomes. Aims

  • To develop a deeper understanding of Cerebral Blood Flow and auto-regulation for TBI patients based on the results of data collected in patients post TBI.
  • To establish the basis for further multi modality clinical trials in severely brain injured patients in the future.
  • To improve understanding of the various secondary processes that continue to cause neuronal damage after the initial injury, and therefore affect patient outcome.
  • To proceed to the second phase of the study, with the introduction of algorithms for treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2002

Typical duration for not_applicable

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
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

May 19, 2008

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

May 16, 2008

Conditions

Traumatic Brain Injury

Interventions

Brain oxygenation and microdialysis cathetersDEVICE

Eligibility Criteria

Age17 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Traumatic Brain Injury with a Glascow Coma Score \< 9 (ie: severe head injury)
  • Traumatic Brain Injury with a Glascow Coma Score \> 8 with an intracranial pressure monitor in situ and CTscan evidence of one or more of the following: Cerebral oedema (Marshall grades III \& IV), midline shift \>5 mm cerebral contusion \>3cm, evacuated subdural haematoma
  • Enrolled within the first 48 hours after trauma
  • Aged 17- 70years

You may not qualify if:

  • Has had a cardiac arrest at or post the trauma scene
  • Pupils are fixed bilaterally and dilated \>4mm,GCS=3
  • Coagulopathy sufficient to contraindicate surgery
  • No chance of survival after consideration of CT and clinical findings
  • Patients with lower limb/pelvic trauma excluded from Innercool monitoring only

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

  • Thomas Kossmann, Professor

    The Alfred

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 14, 2005

Study Start

November 1, 2002

Study Completion

December 1, 2005

Last Updated

May 19, 2008

Record last verified: 2005-09

Locations

AU(1)