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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Azienda Ospedaliera San Gerardo di Monza.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Dott. Giuseppe Citerio, Azienda Ospedaliera San Gerardo di Monza
ClinicalTrials.gov Identifier:
NCT00807833
First received: December 11, 2008
Last updated: September 7, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Traumatic Brain Injury
Subarachnoid Hemorrhage
Procedure: CBF measurement

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Cerebral Blood Flow (CBF) Disturbances Following Traumatic Brain Injury (TBI) and Subarachnoid Hemorrhage (SAH)

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera San Gerardo di Monza:

Primary Outcome Measures:
  • Evaluate the "optimal CPP", defined by PRx, corresponds to the acceptable CBF values [ Time Frame: one week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: one week ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: February 2009
Estimated Study Completion Date: December 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: CBF measurement
    The Thermal Diffusion Probe (TDP) Hemedex® System, allows continuous real-time measurement of cerebral hemodynamic parameters.To date, TDP is the only technique that has been shown to allow for a continuous and quantitative assessment of regional tissue perfusion and the TD-rCBF values have been validated using the Xe-enhanced CT technique
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients admitted with the diagnosis of SAH and requiring intensive monitoring, and ICP probe.
  • Patients admitted diagnosis of severe TBI and requiring intensive monitoring, and ICP probe.

Exclusion criteria:

  • Age < 16 years
  • Previous SAH, brain surgery, stroke, brain trauma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807833

Contacts
Contact: Giuseppe Citerio, DM 0039392334316 g.citerio@hsgerardo.org

Locations
Italy
Azienda Ospedaliera San Gerardo Recruiting
Monza, Italy, 20052
Contact: Giuseppe Citerio, DM    0039392334316    g.citerio@hsgerardo.org   
Sub-Investigator: Federico Villa, DM         
Sub-Investigator: Maria Giulia Abate, DM         
Sponsors and Collaborators
Azienda Ospedaliera San Gerardo di Monza
Investigators
Principal Investigator: Giuseppe Citerio, DM Azienda Ospedaliera San Gerardo Monza
  More Information

Publications:

Responsible Party: Dott. Giuseppe Citerio, MD, Azienda Ospedaliera San Gerardo di Monza
ClinicalTrials.gov Identifier: NCT00807833     History of Changes
Other Study ID Numbers: 08-007
Study First Received: December 11, 2008
Last Updated: September 7, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Azienda Ospedaliera San Gerardo di Monza:
SAH
TBI

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Brain Injuries
Wounds and Injuries
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on April 17, 2014