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Completed

NCT Number: NCT00807833

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Evaluate the "optimal CPP", defined by PRx, corresponds to the acceptable CBF values

    Time frame: one week

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera San Gerardo di Monza

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 12, 2008
Registry last updated
Aug 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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