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CompletedNCT00807833Updated Aug 18, 2015

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

An observational study in Traumatic Brain Injury and Subarachnoid Hemorrhage, sponsored by Azienda Ospedaliera San Gerardo di Monza. Completed at 1 site in Italy. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2015-08-18.

Sponsored by Azienda Ospedaliera San Gerardo di Monza · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
16 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Traumatic Brain Injury
  • Subarachnoid Hemorrhage

Keywords

  • SAH
  • TBI
03

In context

Brain Injuries, Traumatic

1,818 studies on the registry are indexed under Brain Injuries, Traumatic; 460 are open to participants now.

This study's enrollment of 20 is below the median of 119 across 579 observational studies indexed under Brain Injuries, Traumatic.

Browse Brain Injuries, Traumatic studies →

Lead sponsor

Azienda Ospedaliera San Gerardo di Monza is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria:

  • Age \< 16 years
  • Previous SAH, brain surgery, stroke, brain trauma
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • CBF measurement

    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.

06

What researchers measure

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

07

Study locations

1 site
  • Azienda Ospedaliera San Gerardo
    Monza, Italy 20052, Italy
08

References and documents

Publications

  • Claassen J, Vu A, Kreiter KT, Kowalski RG, Du EY, Ostapkovich N, Fitzsimmons BF, Connolly ES, Mayer SA. Effect of acute physiologic derangements on outcome after subarachnoid hemorrhage. Crit Care Med. 2004 Mar;32(3):832-8. doi: 10.1097/01.ccm.0000114830.48833.8a. PubMed 15090970 ↗
  • Vespa P, Bergsneider M, Hattori N, Wu HM, Huang SC, Martin NA, Glenn TC, McArthur DL, Hovda DA. Metabolic crisis without brain ischemia is common after traumatic brain injury: a combined microdialysis and positron emission tomography study. J Cereb Blood Flow Metab. 2005 Jun;25(6):763-74. doi: 10.1038/sj.jcbfm.9600073. PubMed 15716852 ↗
  • Coles JP, Fryer TD, Smielewski P, Chatfield DA, Steiner LA, Johnston AJ, Downey SP, Williams GB, Aigbirhio F, Hutchinson PJ, Rice K, Carpenter TA, Clark JC, Pickard JD, Menon DK. Incidence and mechanisms of cerebral ischemia in early clinical head injury. J Cereb Blood Flow Metab. 2004 Feb;24(2):202-11. doi: 10.1097/01.WCB.0000103022.98348.24. PubMed 14747747 ↗
  • Czosnyka M, Pickard JD. Monitoring and interpretation of intracranial pressure. J Neurol Neurosurg Psychiatry. 2004 Jun;75(6):813-21. doi: 10.1136/jnnp.2003.033126. PubMed 15145991 ↗
  • Lam JM, Smielewski P, Czosnyka M, Pickard JD, Kirkpatrick PJ. Predicting delayed ischemic deficits after aneurysmal subarachnoid hemorrhage using a transient hyperemic response test of cerebral autoregulation. Neurosurgery. 2000 Oct;47(4):819-25; discussions 825-6. doi: 10.1097/00006123-200010000-00004. PubMed 11014420 ↗
  • Hutchinson PJ, Al-Rawi PG, O'Connell MT, Gupta AK, Maskell LB, Hutchinson DB, Pickard JD, Kirkpatrick PJ. Monitoring of brain metabolism during aneurysm surgery using microdialysis and brain multiparameter sensors. Neurol Res. 1999 Jun;21(4):352-8. doi: 10.1080/01616412.1999.11740943. PubMed 10406006 ↗
  • Weyer GW, Nolan CP, Macdonald RL. Evidence-based cerebral vasospasm management. Neurosurg Focus. 2006 Sep 15;21(3):E8. doi: 10.3171/foc.2006.21.3.8. PubMed 17029347 ↗
  • Longstreth WT Jr, Nelson LM, Koepsell TD, van Belle G. Clinical course of spontaneous subarachnoid hemorrhage: a population-based study in King County, Washington. Neurology. 1993 Apr;43(4):712-8. doi: 10.1212/wnl.43.4.712. PubMed 8469328 ↗
  • Biller J, Toffol GJ, Kassell NF, Adams HP Jr, Beck DW, Boarini DJ. Spontaneous subarachnoid hemorrhage in young adults. Neurosurgery. 1987 Nov;21(5):664-7. doi: 10.1227/00006123-198711000-00011. PubMed 3696399 ↗
  • Linn FH, Rinkel GJ, Algra A, van Gijn J. Incidence of subarachnoid hemorrhage: role of region, year, and rate of computed tomography: a meta-analysis. Stroke. 1996 Apr;27(4):625-9. doi: 10.1161/01.str.27.4.625. PubMed 8614919 ↗
  • Robertson CS. Management of cerebral perfusion pressure after traumatic brain injury. Anesthesiology. 2001 Dec;95(6):1513-7. doi: 10.1097/00000542-200112000-00034. No abstract available. PubMed 11748413 ↗
  • Howells T, Elf K, Jones PA, Ronne-Engstrom E, Piper I, Nilsson P, Andrews P, Enblad P. Pressure reactivity as a guide in the treatment of cerebral perfusion pressure in patients with brain trauma. J Neurosurg. 2005 Feb;102(2):311-7. doi: 10.3171/jns.2005.102.2.0311. PubMed 15739560 ↗
  • Soehle M, Jaeger M, Meixensberger J. Online assessment of brain tissue oxygen autoregulation in traumatic brain injury and subarachnoid hemorrhage. Neurol Res. 2003 Jun;25(4):411-7. doi: 10.1179/016164103101201580. PubMed 12870270 ↗
  • Jaeger M, Schuhmann MU, Soehle M, Nagel C, Meixensberger J. Continuous monitoring of cerebrovascular autoregulation after subarachnoid hemorrhage by brain tissue oxygen pressure reactivity and its relation to delayed cerebral infarction. Stroke. 2007 Mar;38(3):981-6. doi: 10.1161/01.STR.0000257964.65743.99. Epub 2007 Feb 1. PubMed 17272764 ↗
  • Vajkoczy P, Horn P, Thome C, Munch E, Schmiedek P. Regional cerebral blood flow monitoring in the diagnosis of delayed ischemia following aneurysmal subarachnoid hemorrhage. J Neurosurg. 2003 Jun;98(6):1227-34. doi: 10.3171/jns.2003.98.6.1227. PubMed 12816269 ↗
  • Vajkoczy P, Roth H, Horn P, Lucke T, Thome C, Hubner U, Martin GT, Zappletal C, Klar E, Schilling L, Schmiedek P. Continuous monitoring of regional cerebral blood flow: experimental and clinical validation of a novel thermal diffusion microprobe. J Neurosurg. 2000 Aug;93(2):265-74. doi: 10.3171/jns.2000.93.2.0265. PubMed 10930012 ↗
  • Vajkoczy P, Horn P, Bauhuf C, Munch E, Hubner U, Ing D, Thome C, Poeckler-Schoeninger C, Roth H, Schmiedek P. Effect of intra-arterial papaverine on regional cerebral blood flow in hemodynamically relevant cerebral vasospasm. Stroke. 2001 Feb;32(2):498-505. doi: 10.1161/01.str.32.2.498. PubMed 11157189 ↗
  • Thome C, Vajkoczy P, Horn P, Bauhuf C, Hubner U, Schmiedek P. Continuous monitoring of regional cerebral blood flow during temporary arterial occlusion in aneurysm surgery. J Neurosurg. 2001 Sep;95(3):402-11. doi: 10.3171/jns.2001.95.3.0402. PubMed 11565860 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00807833
Lead sponsor
Azienda Ospedaliera San Gerardo di Monza
Responsible party
Dott. Giuseppe Citerio (MD, Azienda Ospedaliera San Gerardo di Monza) — Principal investigator
First posted
Dec 12, 2008
Start date
Feb 2009
Primary completion
Jul 2011
Completion
Dec 2011
Last update
Aug 18, 2015

Study contacts

Giuseppe Citerio, DM
principal investigator · Azienda Ospedaliera San Gerardo Monza

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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