Cerebral Blood Flow (CBF) Disturbances Following Traumatic Brain Injury (TBI) and Subarachnoid Hemorrhage (SAH)
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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) |
- Evaluate the "optimal CPP", defined by PRx, corresponds to the acceptable CBF values [ Time Frame: one week ] [ Designated as safety issue: No ]
- 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) |
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Procedure: CBF measurement
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 |
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| Contact: Giuseppe Citerio, DM | 0039392334316 | g.citerio@hsgerardo.org |
| 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 | |
| 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 Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 21, 2013