iNtrAcranial PreSsurE in Intensive Care (ICU) (SynapseICU) | NCT03257904

Studies
iNtrAcranial PreSsurE in Intensive Care (ICU) (SynapseICU)

NCT03257904

Sponsor

University of Milano Bicocca

Status

Completed

Last Update Posted

Jul 7, 2020Actual

Enrollment

2,395Actual

Phase

Not provided

Conditions

Traumatic Brain Injury
Subarachnoid Hemorrhage
Intracerebral Hemorrhage

Interventions

intracranial pressure monitoring

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2018Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Jun 11, 2020Actual

First Submitted Date

Aug 17, 2017

First Submission Date that Met QC Criteria

Aug 19, 2017

First Posted Date

Aug 22, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2020

Last Update Posted Date

Jul 7, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Giuseppe Citerio, MD, Professor, University of Milano BicoccaPrincipal Investigator

Lead Sponsor

University of Milano BicoccaOTHER

Collaborators

Name	Class
European Society of Intensive Care Medicine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Intracranial pressure (ICP) monitoring is the most common neuromonitoring modality used in neurocritical care units (NCCU) around the world. Uncertainties remain around intracranial pressure monitoring both in traumatic and non-traumatic brain injury, and variation in clinical practice of intracranial pressure monitoring exists between neurocritical care units.

The objectives of the study will explore intracranial pressure monitoring variation in practice to prioritise uncertainties in the clinical management of critical care patients with acute brain injury and support further collaborative hypotheses-based prospective studies.

Detailed Description

Sample Size: This international prospective observational study aims to recruit >2000 patients in coma after acute traumatic and non-traumatic brain damage admitted to >200 Intensive Care Units.

Inclusion Criteria:

Acute brain injury (ABI) admitted to ICU following:
1. Hemorrhagic stroke, including intracerebral hematoma and subarachnoid hemorrhage,
2. Traumatic brain injury (penetrating and non-penetrating).
Age >18 years old
Glasgow Coma Score with Eyes response = 1 (no eyes opening) and Motor score ≤5 (not following commands) at the admission to ICU or neuro-worsening within the first 48 hours with no eye opening and the Motor score decreased to ≤5

Exclusion Criteria:

ABI who are not admitted to ICU;
ABI due to infections of the central nervous system, ischemic stroke or other causes not defined in the inclusion criteria

Outcome measures:

Glasgow Outcome Score-Extended at 6 months

Endpoint:

The primary endpoint is the variation in clinical practice around ICP monitoring in acute brain injury patients.

Screening and recruitment: 12 weeks at each centre, or the duration required to enrol 90 patients per centre.

Follow-up: outcome measures will be collected at 6 months.

Duration of study: 2 years.

The SYNAPSE-ICU study is partly funded by ESICM (ESICM Trials Group Portfolio).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,395Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intracranial pressure monitoring	Procedure	measurement of intracranial pressure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Long-term outcome measures of neurological disability	Extended Glasgow Outcome Scale score	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years;
Diagnosis of an acute brain injury (ABI) due to primary hemorrhagic stroke (including intracranial hemorrhage or subarachnoid hemorrhage) or traumatic brain injury;
Glasgow Coma Score with Eyes response = 1 (no eyes opening) and Motor score ≤5 (not following commands) at the admission to ICU or neuro-worsening within the first 48 hours with no eye opening and the Motor score decreased to ≤5.

Exclusion Criteria:

Acute Brain Injury (ABI) who are not admitted to ICU;
ABI due to infections of the central nervous system, ischaemic stroke or other causes not defined in the inclusion criteria.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Hemorrhagic stroke, including intracerebral hematoma and subarachnoid hemorrhage, Traumatic brain injury

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Giuseppe Citerio	University Milano Bicocca	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ASST-Monza		Monza	MB	20900	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28504109	Background	Stocchetti N, Carbonara M, Citerio G, Ercole A, Skrifvars MB, Smielewski P, Zoerle T, Menon DK. Severe traumatic brain injury: targeted management in the intensive care unit. Lancet Neurol. 2017 Jun;16(6):452-464. doi: 10.1016/S1474-4422(17)30118-7.
27654000	Background	Carney N, Totten AM, O'Reilly C, Ullman JS, Hawryluk GW, Bell MJ, Bratton SL, Chesnut R, Harris OA, Kissoon N, Rubiano AM, Shutter L, Tasker RC, Vavilala MS, Wilberger J, Wright DW, Ghajar J. Guidelines for the Management of Severe Traumatic Brain Injury, Fourth Edition. Neurosurgery. 2017 Jan 1;80(1):6-15. doi: 10.1227/NEU.0000000000001432.

ID	Term
D000070642	Brain Injuries, Traumatic
D013345	Subarachnoid Hemorrhage
D002543	Cerebral Hemorrhage

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases