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

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ClinicalTrials.gov Identifier: NCT03257904
Recruitment Status : Recruiting
First Posted : August 22, 2017
Last Update Posted : September 6, 2018
Sponsor:
Collaborator:
European Society of Intensive Care Medicine
Information provided by (Responsible Party):
Giuseppe Citerio, MD, University of Milano Bicocca

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.


Condition or disease Intervention/treatment
Traumatic Brain Injury Subarachnoid Hemorrhage Intracerebral Hemorrhage Procedure: intracranial pressure monitoring

Detailed Description:

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.

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 infection 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).


Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Prospective Observational StudY on iNtrAcranial PreSsurE in Intensive Care (ICU) (SynapseICU)
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: intracranial pressure monitoring
    measurement of intracranial pressure


Primary Outcome Measures :
  1. Long-term outcome measures of neurological disability [ Time Frame: 6 months ]
    Extended Glasgow Outcome Scale score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hemorrhagic stroke, including intracerebral hematoma and subarachnoid hemorrhage, Traumatic brain injury
Criteria

Inclusion Criteria:

  1. Age > 18 years;
  2. Diagnosis of an acute brain injury (ABI) due to primary hemorrhagic stroke (including intracranial hemorrhage or subarachnoid hemorrhage) or traumatic brain injury;
  3. 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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03257904


Contacts
Contact: Giuseppe Citerio +390392334316 gciterio@gmail.com
Contact: Lara Prisco +44 7901 192056 priscolara@gmail.com

Locations
Italy
ASST-Monza Recruiting
Monza, MB, Italy, 20900
Contact: Giuseppe Citerio, MD    +390392334316    giuseppe.citerio@unimib.it   
Sponsors and Collaborators
University of Milano Bicocca
European Society of Intensive Care Medicine
Investigators
Principal Investigator: Giuseppe Citerio University Milano Bicocca

Publications:
Le Roux P, Menon DK, Citerio G, Vespa P, Bader MK, Brophy GM, Diringer MN, Stocchetti N, Videtta W, Armonda R, Badjatia N, Böesel J, Chesnut R, Chou S, Claassen J, Czosnyka M, De Georgia M, Figaji A, Fugate J, Helbok R, Horowitz D, Hutchinson P, Kumar M, McNett M, Miller C, Naidech A, Oddo M, Olson D, O'Phelan K, Provencio JJ, Puppo C, Riker R, Robertson C, Schmidt M, Taccone F; Neurocritical Care Society; European Society of Intensive Care Medicine. Consensus summary statement of the International Multidisciplinary Consensus Conference on Multimodality Monitoring in Neurocritical Care : a statement for healthcare professionals from the Neurocritical Care Society and the European Society of Intensive Care Medicine. Intensive Care Med. 2014 Sep;40(9):1189-209. doi: 10.1007/s00134-014-3369-6. Epub 2014 Aug 20.

Responsible Party: Giuseppe Citerio, MD, Professor, University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT03257904     History of Changes
Other Study ID Numbers: SynapseICU
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Giuseppe Citerio, MD, University of Milano Bicocca:
intracranial pressure

Additional relevant MeSH terms:
Brain Injuries
Hemorrhage
Brain Injuries, Traumatic
Subarachnoid Hemorrhage
Cerebral Hemorrhage
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases