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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00807833
Enrollment
20
Registered
2008-12-12
Start date
2009-02-28
Completion date
2011-12-31
Last updated
2015-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subarachnoid Hemorrhage, Traumatic Brain Injury

Keywords

SAH, TBI

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.

Interventions

None listed

Sponsors

Azienda Ospedaliera San Gerardo di Monza
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Evaluate the optimal CPP, defined by PRx, corresponds to the acceptable CBF valuesone week

Secondary

MeasureTime frame
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 CBFone week

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026