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

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Thermal Diffusion Probe (TDP) Hemedex┬« System Drug
    Intervention Desc: Absolute, real-time continuous perfusion measured from 0 to 200 ml/100g-min. Works with the thermal diffusion probe (TDP) - a minimally invasive (<1 mm diameter) flexible, interstitial catheter.
  • CBF measurement Procedure
    Intervention Desc: 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

Trial Design

  • Masking: Open Label
  • Purpose: Diagnostic
  • Intervention: Single Group Assignment
  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

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.

Patient Involvement

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.

Outcomes

Type Measure Time Frame Safety Issue
Primary Evaluate the 'optimal CPP', defined by PRx, corresponds to the acceptable CBF values.
Secondary 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.
Primary Evaluate the "optimal CPP", defined by PRx, corresponds to the acceptable CBF values one week No
Secondary 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 No

Sponsors