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Clinical Trials/NCT00807833
NCT00807833
Completed
Not Applicable

Cerebral Blood Flow (CBF) Disturbances Following Traumatic Brain Injury (TBI) and Subarachnoid Hemorrhage (SAH)

Azienda Ospedaliera San Gerardo di Monza1 site in 1 country20 target enrollmentFebruary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
Azienda Ospedaliera San Gerardo di Monza
Enrollment
20
Locations
1
Primary Endpoint
Evaluate the "optimal CPP", defined by PRx, corresponds to the acceptable CBF values
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

It is a "proof of concept" study, aimed to evaluate whether the "optimal CPP", defined by the best PRx, corresponds to the acceptable CBF values in patients affected by CBF disfunction caused by TBI or SAH.

Detailed Description

Cerebral blood flow (CBF) disturbances are common following TBI and SAH. The occurrence of CBF derangements is detrimental for the neurological outcome in both settings, but the management of neurologically critically ill patients does not involve CBF measure routinely. Cerebrovascular autoregulation, can be assessed by the cerebrovascular pressure-reactivity index (PRx) that point out the response of ICP to spontaneous changes in arterial blood pressure (ABP). Autoregulation has been proven to be a powerful protective mechanism. Adding together the information on CBF and autoregulation, might drive clinical strategy in exceptionally noteworthy and innovative way. Currently, a novel Thermal Diffusion (TDP) microprobe has been introduced for the continuous bedside monitoring of regional CBF: TDP is a promising technique in the reliable detection of flow derangements at the patient's bedside. It is a "proof of concept" study, aimed to evaluate whether the "optimal CPP", defined by the best PRx, corresponds to the acceptable CBF values. Patients admitted with the diagnosis of TBI and SAH in for whom ICP and CPP needs to be monitored on clinical ground will be also monitored with a TD probe and routinely tested for cerebral autoregulation, thus obtaining the CBF corresponding at a given the "best CPP" and autoregulation status. Continuous CBF measures and PRx monitoring may allow more accurate identification and early detection of adverse cerebral conditions. This approach may bring us a step closer to the goal of outcome improvements in patients suffering from intracranial insult.

Registry
clinicaltrials.gov
Start Date
February 2009
End Date
December 2011
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Azienda Ospedaliera San Gerardo di Monza
Responsible Party
Principal Investigator
Principal Investigator

Dott. Giuseppe Citerio

MD

Azienda Ospedaliera San Gerardo di Monza

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Evaluate the "optimal CPP", defined by PRx, corresponds to the acceptable CBF values

Time Frame: one week

Secondary Outcomes

  • Compare in cohort group PRx/CPP curve to CBFx/CPP curve.The "CBFx" index is defined as the moving correlation between slow waves in CPP and CBF(one week)

Study Sites (1)

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