Traumatic Brain InjuryNCT00807833
Cerebral Blood Flow (CBF) Disturbances Following Traumatic Brain Injury (TBI) and Subarachnoid Hemorrhage (SAH)
An observational study of Traumatic Brain Injury and Subarachnoid Hemorrhage, run by Azienda Ospedaliera San Gerardo di Monza at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Traumatic Brain Injury, Subarachnoid Hemorrhage
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2009to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Age < 16 years
- Previous SAH, brain surgery, stroke, brain trauma
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Traumatic Brain Injury, Subarachnoid Hemorrhage
- Keywords
- SAH, TBI
- Medical subject headings
- Brain Injuries, Traumatic, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the "optimal CPP", defined by PRx, corresponds to the acceptable CBF values
Measured: 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
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionJul 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera San Gerardo di Monza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dott. Giuseppe Citerio, Azienda Ospedaliera San Gerardo di Monza
- Investigators
- Giuseppe Citerio, DM, Principal investigator, Azienda Ospedaliera San Gerardo Monza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807833
- Sponsor's protocol ID
- 08-007
- Status last verified
- Aug 2015
- First submitted
- 11 Dec 2008
- Last updated
- 18 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
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 15090970Vespa 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 15716852Coles 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 14747747Czosnyka 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 15145991Lam 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 11014420Hutchinson 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 10406006Weyer 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 17029347Longstreth 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 8469328Biller 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 3696399Linn 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 8614919Robertson 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 11748413Howells 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 15739560Soehle 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 12870270Jaeger 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 17272764Vajkoczy 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Blood Flow (CBF) Disturbances Following Traumatic Brain Injury (TBI) and Subarachnoid Hemorrhage (SAH)
- ClinicalTrials.gov ID
- NCT00807833
- Acronym / sponsor ID
- 08-007
- Conditions
- Traumatic Brain Injury, Subarachnoid Hemorrhage
- Keywords
- SAH, TBI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Azienda Ospedaliera San Gerardo di MonzaUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Age < 16 years
- Previous SAH, brain surgery, stroke, brain trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the "optimal CPP", defined by PRx, corresponds to the acceptable CBF values
Time frame: one week
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2015.
- Background: PubMed 15090970Claassen 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.
- Background: PubMed 15716852Vespa 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.
- Background: PubMed 14747747Coles 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.
- Background: PubMed 15145991Czosnyka 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.
- Background: PubMed 11014420Lam 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.
- Background: PubMed 10406006Hutchinson 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.
- Background: PubMed 17029347Weyer 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.
- Background: PubMed 8469328Longstreth 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.
- Background: PubMed 3696399Biller 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.
- Background: PubMed 8614919Linn 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.
- Background: PubMed 11748413Robertson 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.
- Background: PubMed 15739560Howells 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Citerio, DM principal investigator
Azienda Ospedaliera San Gerardo Monza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Subarachnoid Hemorrhage, run by Azienda Ospedaliera San Gerardo di Monza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the "optimal CPP", defined by PRx, corresponds to the acceptable CBF values (time frame: one week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00807833, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2015.