Ignite Creation Date:
2024-05-05 @ 9:04 PM
Last Modification Date:
2024-10-26 @ 9:59 AM
Study NCT ID:
NCT00807833
Status:
COMPLETED
Last Update Posted:
2015-08-18
First Post:
2008-12-11
Brief Title:
Cerebral Blood Flow CBF Disturbances Following Traumatic Brain Injury TBI and Subarachnoid Hemorrhage SAH
Sponsor:
Azienda Ospedaliera San Gerardo di Monza
Organization:
Azienda Ospedaliera San Gerardo di Monza
Study Overview
Official Title:
Cerebral Blood Flow CBF Disturbances Following Traumatic Brain Injury TBI and Subarachnoid Hemorrhage SAH
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None