Intra Cerebral HemorrhageCLOSEDNCT06057155
Intracranial Pressure and Optic Nerve Sheath Diameter With CLOSED Bundle
An observational study of Intra Cerebral Hemorrhage and Subarachnoid Hemorrhage, Aneurysmal, run by IRCCS Istituto delle Scienze Neurologiche di Bologna at 1 site in Italy.
Trial summary
The design of the present study will be a multicenter prospective observational protocol. Approximately 100 patients will be recruited over the 24-month period with Acute Brain Injury (trauma brain injury, intracerebral hemorrhage, subarachnoid hemorrhage, ischemic stroke), who in their acute phase of intensive care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra Cerebral Hemorrhage, Subarachnoid Hemorrhage, Aneurysmal, Trauma, Brain
- What is being tested?
- ultrasound optic nerve sheath diameter assessment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2024to 1 Jun 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: acute brain injury patients at risk of intra-cranial hypertension
Who may be able to join
- acute brain injury patients with an invasive intra-cranial pressure monitoring
- -
Who cannot join
- patients affected by disease or trauma of eye ball patients or relatives that don't want to participate to the study
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Intracranial Pressure and Optic Nerve Sheath Diameter Measured With CLOSED Bundle in Patients With Acute Brain Injury: Multicenter Observational Study
The design of the present study will be a multicenter prospective observational protocol. Approximately 100 patients will be recruited over the 24-month period with Acute Brain Injury (trauma brain injury, intracerebral hemorrhage, subarachnoid hemorrhage, ischemic stroke), who in their acute phase of intensive care unit require placement of a catheter capable of monitoring intracranial pressure (intra parenchymal catheter or external ventricular shunt). In addition to all the intensive care provided by the most recent guidelines, patients will undergo measurement of optic nerve sheath diameter through ultrasonography. At least, three measurements will be performed within the first 3 hours after admission, within the first 24-48 hours, and at each invasive intracranial pressure value greater than 18 cmH2O. Those patients with intracranial pressure values greater than 35 mmHg. At the first intracranial pressure measurement, patients with eyeball disease or trauma will be excluded. Measurements will be performed following the CLOSED bundle.
Analysis of the results will include correlation between the invasive pressure values and the mean value of optic nerve sheath diameter measurements in the two projections (sagittal and transverse). In addition, the correlation of the absolute value of invasive pressure detected with the ratio of the optic nerve sheath diameter measurement to the eyeball diameter measured always ultrasound will be sought.
- Conditions
- Intra Cerebral Hemorrhage, Subarachnoid Hemorrhage, Aneurysmal, Trauma, Brain, Hypertension Intracranial, Stroke, Ischemic
- Being tested
- ultrasound optic nerve sheath diameter assessment
- Keywords
- optic nerve sheath diameter, ultrasonography, Hypertension Intracranial, neuro monitoring
- Medical subject headings
- Cerebral Hemorrhage, Subarachnoid Hemorrhage, Brain Injuries, Traumatic, Intracranial Hypertension, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound optic nerve sheath diameter assessmentDiagnostic test
ultrasound optic nerve sheath diameter assessment
| Study group | Role | What they receive |
|---|---|---|
| acute brain injury | Intra Cerebral Hemorrhage Subarachnoid Hemorrhage, Aneurysmal Trauma, Brain Stroke, Ischemic Receives: Diagnostic Test: ultrasound optic nerve sheath diameter assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between invasive ICP/ONSD
correlation between invasive intra-cranial pression assessment and ultasound ONSD assessment
Measured: 3, 24, 48 hours after admission
Secondary outcomes (1)
correlation between invasive intra-cranial pression assessment and ultasound ratio of ONSD assessment and eyeball transverse diameter
correlation between invasive ICP/(ONSD/ETD)
Measured: 3, 24, 48 hours after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 May 2024 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Intra Cerebral HemorrhageStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Istituto delle Scienze Neurologiche di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raffaele Aspide, IRCCS Istituto delle Scienze Neurologiche di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057155
- Sponsor's protocol ID
- 6669
- Acronym
- CLOSED
- Status last verified
- Mar 2024
- First submitted
- 21 Sep 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Publications
Hansen HC, Helmke K. Validation of the optic nerve sheath response to changing cerebrospinal fluid pressure: ultrasound findings during intrathecal infusion tests. J Neurosurg. 1997 Jul;87(1):34-40. doi: 10.3171/jns.1997.87.1.0034.
PubMed 9202262Liu D, Kahn M. Measurement and relationship of subarachnoid pressure of the optic nerve to intracranial pressures in fresh cadavers. Am J Ophthalmol. 1993 Nov 15;116(5):548-56. doi: 10.1016/s0002-9394(14)73195-2.
PubMed 8238213Zoerle T, Caccioppola A, D'Angelo E, Carbonara M, Conte G, Avignone S, Zanier ER, Birg T, Ortolano F, Triulzi F, Stocchetti N. Optic Nerve Sheath Diameter is not Related to Intracranial Pressure in Subarachnoid Hemorrhage Patients. Neurocrit Care. 2020 Oct;33(2):491-498. doi: 10.1007/s12028-020-00970-y.
PubMed 32314244Vitiello L, De Bernardo M, Rosa N. Optic Nerve Sheath Diameter Evaluation With Two Ultrasound Techniques in Patients at Risk for Increased Intracranial Pressure. Crit Care Med. 2019 Sep;47(9):e787. doi: 10.1097/CCM.0000000000003811. No abstract available.
PubMed 31415320Vaiman M, Abuita R, Bekerman I. Optic nerve sheath diameters in healthy adults measured by computer tomography. Int J Ophthalmol. 2015 Dec 18;8(6):1240-4. doi: 10.3980/j.issn.2222-3959.2015.06.30. eCollection 2015.
PubMed 26682181Patterson DF, Ho ML, Leavitt JA, Smischney NJ, Hocker SE, Wijdicks EF, Hodge DO, Chen JJ. Comparison of Ocular Ultrasonography and Magnetic Resonance Imaging for Detection of Increased Intracranial Pressure. Front Neurol. 2018 Apr 24;9:278. doi: 10.3389/fneur.2018.00278. eCollection 2018.
PubMed 29740393Cochrane Central Register of Controlled Trials - Optic nerve sheath diameter as a marker of raised intracranial pressure in pediatric patients with suspected ventriculoperitoneal shunt malfunction: a pilot study Ramirez T, Abdeen N Pediatric radiology. Conference: 60th annual meeting of the society for pediatric radiology, SPR 2017. Canada, 2017, 47, S255-S256 | added to CENTRAL: 30 June 2017 | 2017 Issue 6 https://doi.org/10.1007/s00247-017-3809-x
Robba C, Santori G, Czosnyka M, Corradi F, Bragazzi N, Padayachy L, Taccone FS, Citerio G. Optic nerve sheath diameter measured sonographically as non-invasive estimator of intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2018 Aug;44(8):1284-1294. doi: 10.1007/s00134-018-5305-7. Epub 2018 Jul 17.
PubMed 30019201Montorfano L, Yu Q, Bordes SJ, Sivanushanthan S, Rosenthal RJ, Montorfano M. Mean value of B-mode optic nerve sheath diameter as an indicator of increased intracranial pressure: a systematic review and meta-analysis. Ultrasound J. 2021 Jul 2;13(1):35. doi: 10.1186/s13089-021-00235-5.
PubMed 34215966Aletreby W, Alharthy A, Brindley PG, Kutsogiannis DJ, Faqihi F, Alzayer W, Balhahmar A, Soliman I, Hamido H, Alqahtani SA, Karakitsos D, Blaivas M. Optic Nerve Sheath Diameter Ultrasound for Raised Intracranial Pressure: A Literature Review and Meta-analysis of its Diagnostic Accuracy. J Ultrasound Med. 2022 Mar;41(3):585-595. doi: 10.1002/jum.15732. Epub 2021 Apr 24.
PubMed 33893746Cardim D, Griesdale DE, Ainslie PN, Robba C, Calviello L, Czosnyka M, Smielewski P, Sekhon MS. A comparison of non-invasive versus invasive measures of intracranial pressure in hypoxic ischaemic brain injury after cardiac arrest. Resuscitation. 2019 Apr;137:221-228. doi: 10.1016/j.resuscitation.2019.01.002. Epub 2019 Jan 7.
PubMed 30629992Aspide R, Bertolini G, Albini Riccioli L, Mazzatenta D, Palandri G, Biasucci DG. A Proposal for a New Protocol for Sonographic Assessment of the Optic Nerve Sheath Diameter: The CLOSED Protocol. Neurocrit Care. 2020 Feb;32(1):327-332. doi: 10.1007/s12028-019-00853-x.
PubMed 31583527Aspide R, Bertolini G, Belotti LMB, Albini Riccioli L, Toni F, Mazzatenta D, Palandri G, Vetrugno L, Biasucci DG. The CLOSED protocol to assess optic nerve sheath diameter using color-Doppler: a comparison study in a cohort of idiopathic normal pressure hydrocephalus patients. Ultrasound J. 2022 Oct 29;14(1):43. doi: 10.1186/s13089-022-00291-5.
PubMed 36309606Aspide R, Bertolini G, Belotti LMB, Albini Riccioli L, Toni F, Mazzatenta D, Palandri G, Vetrugno L, Biasucci DG. Magnetic Resonance-Based Assessment of Optic Nerve Sheath Diameter: A Prospective Observational Cohort Study on Inter- and Intra-Rater Agreement. J Clin Med. 2023 Apr 5;12(7):2713. doi: 10.3390/jcm12072713.
PubMed 37048796Toms DA. The mechanical index, ultrasound practices, and the ALARA principle. J Ultrasound Med. 2006 Apr;25(4):560-1; author reply 561-2. doi: 10.7863/jum.2006.25.4.560. No abstract available.
PubMed 16567451
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Intracranial Pressure and Optic Nerve Sheath Diameter Measured With CLOSED Bundle in Patients With Acute Brain Injury: Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT06057155
- Acronym / sponsor ID
- CLOSED / 6669
- Conditions
- Intra Cerebral Hemorrhage, Subarachnoid Hemorrhage, Aneurysmal, Trauma, Brain, Hypertension Intracranial, Stroke, Ischemic
- Keywords
- optic nerve sheath diameter, ultrasonography, Hypertension Intracranial, neuro monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- IRCCS Istituto delle Scienze Neurologiche di BolognaUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 28 Sep 2023 (actual)
- 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.
The design of the present study will be a multicenter prospective observational protocol. Approximately 100 patients will be recruited over the 24-month period with Acute Brain Injury (trauma brain injury, intracerebral hemorrhage, subarachnoid hemorrhage, ischemic stroke), who in their acute phase of intensive care unit require placement of a catheter capable of monitoring intracranial pressure (intra parenchymal catheter or external ventricular shunt). In addition to all the intensive care provided by the most recent guidelines, patients will undergo measurement of optic nerve sheath diameter through ultrasonography. At least, three measurements will be performed within the first 3 hours after admission, within the first 24-48 hours, and at each invasive intracranial pressure value greater than 18 cmH2O. Those patients with intracranial pressure values greater than 35 mmHg. At the first intracranial pressure measurement, patients with eyeball disease or trauma will be excluded. Measurements will be performed following the CLOSED bundle.
Analysis of the results will include correlation between the invasive pressure values and the mean value of optic nerve sheath diameter measurements in the two projections (sagittal and transverse). In addition, the correlation of the absolute value of invasive pressure detected with the ratio of the optic nerve sheath diameter measurement to the eyeball diameter measured always ultrasound will be sought.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute brain injury | – | Diagnostic Test: ultrasound optic nerve sheath diameter assessmentIntra Cerebral Hemorrhage Subarachnoid Hemorrhage, Aneurysmal Trauma, Brain Stroke, Ischemic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- acute brain injury patients at risk of intra-cranial hypertension
Key inclusion criteria (2 listed)
- acute brain injury patients with an invasive intra-cranial pressure monitoring
- -
Key exclusion criteria (2 listed)
- patients affected by disease or trauma of eye ball patients or relatives that don't want to participate to the study
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound optic nerve sheath diameter assessmentultrasound optic nerve sheath diameter assessment | Diagnostic test | acute brain injury |
Primary outcome
correlation between invasive ICP/ONSD
Time frame: 3, 24, 48 hours after admission
correlation between invasive intra-cranial pression assessment and ultasound ONSD assessment
1 secondary outcome
correlation between invasive intra-cranial pression assessment and ultasound ratio of ONSD assessment and eyeball transverse diameter
Time frame: 3, 24, 48 hours after admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Background: PubMed 9202262Hansen HC, Helmke K. Validation of the optic nerve sheath response to changing cerebrospinal fluid pressure: ultrasound findings during intrathecal infusion tests. J Neurosurg. 1997 Jul;87(1):34-40. doi: 10.3171/jns.1997.87.1.0034.
- Background: PubMed 8238213Liu D, Kahn M. Measurement and relationship of subarachnoid pressure of the optic nerve to intracranial pressures in fresh cadavers. Am J Ophthalmol. 1993 Nov 15;116(5):548-56. doi: 10.1016/s0002-9394(14)73195-2.
- Background: PubMed 32314244Zoerle T, Caccioppola A, D'Angelo E, Carbonara M, Conte G, Avignone S, Zanier ER, Birg T, Ortolano F, Triulzi F, Stocchetti N. Optic Nerve Sheath Diameter is not Related to Intracranial Pressure in Subarachnoid Hemorrhage Patients. Neurocrit Care. 2020 Oct;33(2):491-498. doi: 10.1007/s12028-020-00970-y.
- Background: PubMed 31415320Vitiello L, De Bernardo M, Rosa N. Optic Nerve Sheath Diameter Evaluation With Two Ultrasound Techniques in Patients at Risk for Increased Intracranial Pressure. Crit Care Med. 2019 Sep;47(9):e787. doi: 10.1097/CCM.0000000000003811. No abstract available.
- Background: PubMed 26682181Vaiman M, Abuita R, Bekerman I. Optic nerve sheath diameters in healthy adults measured by computer tomography. Int J Ophthalmol. 2015 Dec 18;8(6):1240-4. doi: 10.3980/j.issn.2222-3959.2015.06.30. eCollection 2015.
- Background: PubMed 29740393Patterson DF, Ho ML, Leavitt JA, Smischney NJ, Hocker SE, Wijdicks EF, Hodge DO, Chen JJ. Comparison of Ocular Ultrasonography and Magnetic Resonance Imaging for Detection of Increased Intracranial Pressure. Front Neurol. 2018 Apr 24;9:278. doi: 10.3389/fneur.2018.00278. eCollection 2018.
- BackgroundCochrane Central Register of Controlled Trials - Optic nerve sheath diameter as a marker of raised intracranial pressure in pediatric patients with suspected ventriculoperitoneal shunt malfunction: a pilot study Ramirez T, Abdeen N Pediatric radiology. Conference: 60th annual meeting of the society for pediatric radiology, SPR 2017. Canada, 2017, 47, S255-S256 | added to CENTRAL: 30 June 2017 | 2017 Issue 6 https://doi.org/10.1007/s00247-017-3809-x
- Background: PubMed 30019201Robba C, Santori G, Czosnyka M, Corradi F, Bragazzi N, Padayachy L, Taccone FS, Citerio G. Optic nerve sheath diameter measured sonographically as non-invasive estimator of intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2018 Aug;44(8):1284-1294. doi: 10.1007/s00134-018-5305-7. Epub 2018 Jul 17.
- Background: PubMed 34215966Montorfano L, Yu Q, Bordes SJ, Sivanushanthan S, Rosenthal RJ, Montorfano M. Mean value of B-mode optic nerve sheath diameter as an indicator of increased intracranial pressure: a systematic review and meta-analysis. Ultrasound J. 2021 Jul 2;13(1):35. doi: 10.1186/s13089-021-00235-5.
- Background: PubMed 33893746Aletreby W, Alharthy A, Brindley PG, Kutsogiannis DJ, Faqihi F, Alzayer W, Balhahmar A, Soliman I, Hamido H, Alqahtani SA, Karakitsos D, Blaivas M. Optic Nerve Sheath Diameter Ultrasound for Raised Intracranial Pressure: A Literature Review and Meta-analysis of its Diagnostic Accuracy. J Ultrasound Med. 2022 Mar;41(3):585-595. doi: 10.1002/jum.15732. Epub 2021 Apr 24.
- Background: PubMed 30629992Cardim D, Griesdale DE, Ainslie PN, Robba C, Calviello L, Czosnyka M, Smielewski P, Sekhon MS. A comparison of non-invasive versus invasive measures of intracranial pressure in hypoxic ischaemic brain injury after cardiac arrest. Resuscitation. 2019 Apr;137:221-228. doi: 10.1016/j.resuscitation.2019.01.002. Epub 2019 Jan 7.
- Background: PubMed 31583527Aspide R, Bertolini G, Albini Riccioli L, Mazzatenta D, Palandri G, Biasucci DG. A Proposal for a New Protocol for Sonographic Assessment of the Optic Nerve Sheath Diameter: The CLOSED Protocol. Neurocrit Care. 2020 Feb;32(1):327-332. doi: 10.1007/s12028-019-00853-x.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Intra Cerebral Hemorrhage and Subarachnoid Hemorrhage, Aneurysmal, run by IRCCS Istituto delle Scienze Neurologiche di Bologna 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: status not confirmed, as of the sponsor's last update on 6 Mar 2024. 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?
Results are not available in the source record.
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?
correlation between invasive ICP/ONSD (time frame: 3, 24, 48 hours after admission). 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 NCT06057155, which also lists 15 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 6 Mar 2024.