Last reviewed · How we verify
NCT06057155: CLOSED
Intracranial Pressure and Optic Nerve Sheath Diameter With CLOSED Bundle
trial testing ultrasound optic nerve sheath diameter assessment in Intra Cerebral Hemorrhage in 150 participants. Not yet recruiting.
1 November 2025
Quick facts
| Lead sponsor | IRCCS Istituto delle Scienze Neurologiche di Bologna |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 150 |
| Start date | 1 May 2024 |
| Primary completion | 1 November 2025 |
| Estimated completion | 1 June 2026 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- ultrasound optic nerve sheath diameter assessment
Conditions studied
- Intra Cerebral Hemorrhage — all drugs for Intra Cerebral Hemorrhage →
- Subarachnoid Hemorrhage, Aneurysmal — all drugs for Subarachnoid Hemorrhage, Aneurysmal →
- Trauma, Brain — all drugs for Trauma, Brain →
- Hypertension Intracranial — all drugs for Hypertension Intracranial →
Sponsor
IRCCS Istituto delle Scienze Neurologiche di Bologna — full company profile →
Who can join
18 and older, any sex, with Intra Cerebral Hemorrhage or Subarachnoid Hemorrhage, Aneurysmal. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06057155
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Related trials
Other recruiting trials for Intra Cerebral Hemorrhage
Currently open trials in the same condition.
- NCT06383741 — Predicting Outcomes in ICH Patients on Direct Factor Xa Inhibitors · recruiting
- NCT03990558 — Recovery of Consciousness Following Intracerebral Hemorrhage · recruiting
Other IRCCS Istituto delle Scienze Neurologiche di Bologna trials
Trials by the same sponsor.
- NCT06316232 — DBS and Levodopa for Treating Freezing of Gait in Parkinson's Disease · Phase 4 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06057155 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IRCCS Istituto delle Scienze Neurologiche di Bologna
- Last refreshed: 6 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06057155.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing