Cerebral Blood Flow (CBF) Disturbances Following Traumatic Brain Injury (TBI) and Subarachnoid Hemorrhage (SAH)
This study is currently recruiting participants.
Verified September 2011 by Azienda Ospedaliera San Gerardo di Monza
Sponsor:
Azienda Ospedaliera San Gerardo di Monza
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
| Tracking Information | |||||
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| First Received Date ICMJE | December 11, 2008 | ||||
| Last Updated Date | September 7, 2011 | ||||
| Start Date ICMJE | February 2009 | ||||
| Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Evaluate the "optimal CPP", defined by PRx, corresponds to the acceptable CBF values [ Time Frame: one week ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00807833 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cerebral Blood Flow (CBF) Disturbances Following Traumatic Brain Injury (TBI) and Subarachnoid Hemorrhage (SAH) | ||||
| Official Title ICMJE | Cerebral Blood Flow (CBF) Disturbances Following Traumatic Brain Injury (TBI) and Subarachnoid Hemorrhage (SAH) | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Arm (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | December 2011 | ||||
| Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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| Gender | Both | ||||
| Ages | 16 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Italy | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00807833 | ||||
| Other Study ID Numbers ICMJE | 08-007 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dott. Giuseppe Citerio, Azienda Ospedaliera San Gerardo di Monza | ||||
| Study Sponsor ICMJE | Azienda Ospedaliera San Gerardo di Monza | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Azienda Ospedaliera San Gerardo di Monza | ||||
| Verification Date | September 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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