Intensive Monitoring of Brain Injured Patients
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|ClinicalTrials.gov Identifier: NCT00163774|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : May 19, 2008
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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury||Device: Brain oxygenation and microdialysis catheters||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intensive Monitoring of Brain Injured Patients; Icp Monitoring, Transcranial Doppler, Jugular Bulb Oximetry, Brain Oxygenation, Brain Temperature and Microdialysis.|
|Study Start Date :||November 2002|
|Study Completion Date :||December 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00163774
|The Alfred Hospital|
|Melbourne, Victoria, Australia, 3004|
|Principal Investigator:||Thomas Kossmann, Professor||The Alfred|