search
Back to results

Intensive Monitoring of Brain Injured Patients

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Brain oxygenation and microdialysis catheters
Sponsored by
Bayside Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

17 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • The Alfred Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
May 16, 2008
Sponsor
Bayside Health
search

1. Study Identification

Unique Protocol Identification Number
NCT00163774
Brief Title
Intensive Monitoring of Brain Injured Patients
Official Title
Intensive Monitoring of Brain Injured Patients; Icp Monitoring, Transcranial Doppler, Jugular Bulb Oximetry, Brain Oxygenation, Brain Temperature and Microdialysis.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Bayside Health

4. Oversight

5. Study Description

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.
Detailed Description
The ultimate aim of this study is to improve the outcome of patients with severe head injury by reducing secondary brain injury. It is hoped that this will be achieved by improving clinical management through the adoption of Best Practice monitoring measures. The severe head injury population is a disparate clinical group with varying CBF derangements, and complex inter-relationships between the various physiological parameters which are being measured. Common protocol based therapy for all head-injured patients is simplistic and cannot fully accommodate the variations between patients or within an individual brain. We believe that to improve outcome, these individual derangements and patterns have to be identified and the correct therapeutic combinations fashioned on an individual basis. This is not the current practice in Australia. The first phase of this project was completed in March 2004 following the recruitment of ten patients. These patients were intensively monitored and based on the data collected and current international literature we devised a new treatment protocol for patients with severe head injuries. We anticipate that implementation of this new protocol will improve outcome. We aim to: further clarify what the above mentioned relationships between monitoring parameters are, what are the most critical ones and the effect that optimisation of these parameters has on brain swelling, ICP control and on clinical outcome. introduce treatment algorithms/protocols to alter the haemodynamic parameters, CPP and ICP and to optimise PbrO2. study the patients having decompressive craniectomy using these techniques where possible compare patient outcomes to previous outcome studies at the Alfred Hospital.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Brain oxygenation and microdialysis catheters

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Kossmann, Professor
Organizational Affiliation
The Alfred
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

Intensive Monitoring of Brain Injured Patients

We'll reach out to this number within 24 hrs