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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807833
• Other study ID #: 08-007
• Status: Completed
• Phase: N/A
• First received: December 11, 2008
• Last updated: August 17, 2015
• Start date: February 2009
• Est. completion date: December 2011

Study information

• Verified date: August 2015
• Source: Azienda Ospedaliera San Gerardo di Monza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Hemorrhage
• Subarachnoid Hemorrhage
• Traumatic Brain Injury

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera San Gerardo	Monza

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera San Gerardo di Monza

Country where clinical trial is conducted

Italy, 

References & Publications (18)

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. — View Citation

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. — View Citation

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. — View Citation

Czosnyka M, Pickard JD. Monitoring and interpretation of intracranial pressure. J Neurol Neurosurg Psychiatry. 2004 Jun;75(6):813-21. Review. — View Citation

Howells T, Elf K, Jones PA, Ronne-Engström 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. — View Citation

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. — View Citation

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. Epub 2007 Feb 1. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Robertson CS. Management of cerebral perfusion pressure after traumatic brain injury. Anesthesiology. 2001 Dec;95(6):1513-7. Review. — View Citation

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. — View Citation

Thomé C, Vajkoczy P, Horn P, Bauhuf C, Hübner 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. — View Citation

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. — View Citation

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. — View Citation

Vajkoczy P, Roth H, Horn P, Lucke T, Thomé 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. — View Citation

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. — View Citation

Weyer GW, Nolan CP, Macdonald RL. Evidence-based cerebral vasospasm management. Neurosurg Focus. 2006 Sep 15;21(3):E8. Review. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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