Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-02 @ 12:57 PM
Study NCT ID:
NCT03257904
Status:
COMPLETED
Last Update Posted:
2020-07-07
First Post:
2017-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iNtrAcranial PreSsurE in Intensive Care (ICU) (SynapseICU)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}, {'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D002543', 'term': 'Cerebral Hemorrhage'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2395}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-01', 'studyFirstSubmitDate': '2017-08-17', 'studyFirstSubmitQcDate': '2017-08-19', 'lastUpdatePostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long-term outcome measures of neurological disability', 'timeFrame': '6 months', 'description': 'Extended Glasgow Outcome Scale score'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intracranial pressure'], 'conditions': ['Traumatic Brain Injury', 'Subarachnoid Hemorrhage', 'Intracerebral Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '28504109', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27654000', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '26431625', 'type': 'BACKGROUND', 'citation': 'Cnossen MC, Scholten AC, Lingsma HF, Synnot A, Tavender E, Gantner D, Lecky F, Steyerberg EW, Polinder S. Adherence to Guidelines in Adult Patients with Traumatic Brain Injury: A Living Systematic Review. J Neurotrauma. 2021 Apr 15;38(8):1072-1085. doi: 10.1089/neu.2015.4121. Epub 2016 Aug 25.'}, {'pmid': '25208677', 'type': 'BACKGROUND', 'citation': 'Helbok R, Olson DM, Le Roux PD, Vespa P; Participants in the International Multidisciplinary Consensus Conference on Multimodality Monitoring. Intracranial pressure and cerebral perfusion pressure monitoring in non-TBI patients: special considerations. Neurocrit Care. 2014 Dec;21 Suppl 2:S85-94. doi: 10.1007/s12028-014-0040-6.'}, {'pmid': '26061135', 'type': 'BACKGROUND', 'citation': 'Chesnut RM, Bleck TP, Citerio G, Classen J, Cooper DJ, Coplin WM, Diringer MN, Grande PO, Hemphill JC 3rd, Hutchinson PJ, Le Roux P, Mayer SA, Menon DK, Myburgh JA, Okonkwo DO, Robertson CS, Sahuquillo J, Stocchetti N, Sung G, Temkin N, Vespa PM, Videtta W, Yonas H. A Consensus-Based Interpretation of the Benchmark Evidence from South American Trials: Treatment of Intracranial Pressure Trial. J Neurotrauma. 2015 Nov 15;32(22):1722-4. doi: 10.1089/neu.2015.3976. Epub 2015 Aug 31.'}, {'pmid': '26022637', 'type': 'BACKGROUND', 'citation': 'Hemphill JC 3rd, Greenberg SM, Anderson CS, Becker K, Bendok BR, Cushman M, Fung GL, Goldstein JN, Macdonald RL, Mitchell PH, Scott PA, Selim MH, Woo D; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Clinical Cardiology. Guidelines for the Management of Spontaneous Intracerebral Hemorrhage: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2015 Jul;46(7):2032-60. doi: 10.1161/STR.0000000000000069. Epub 2015 May 28.'}, {'pmid': '25208680', 'type': 'BACKGROUND', 'citation': 'Chesnut R, Videtta W, Vespa P, Le Roux P; Participants in the International Multidisciplinary Consensus Conference on Multimodality Monitoring. Intracranial pressure monitoring: fundamental considerations and rationale for monitoring. Neurocrit Care. 2014 Dec;21 Suppl 2:S64-84. doi: 10.1007/s12028-014-0048-y.'}, {'pmid': '25138226', 'type': 'BACKGROUND', 'citation': "Le Roux P, Menon DK, Citerio G, Vespa P, Bader MK, Brophy GM, Diringer MN, Stocchetti N, Videtta W, Armonda R, Badjatia N, Boesel 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."}, {'pmid': '25184881', 'type': 'BACKGROUND', 'citation': 'Stocchetti N, Maas AI. Traumatic intracranial hypertension. N Engl J Med. 2014 Sep 4;371(10):972. doi: 10.1056/NEJMc1407775. No abstract available.'}, {'pmid': '9726257', 'type': 'BACKGROUND', 'citation': 'Wilson JT, Pettigrew LE, Teasdale GM. Structured interviews for the Glasgow Outcome Scale and the extended Glasgow Outcome Scale: guidelines for their use. J Neurotrauma. 1998 Aug;15(8):573-85. doi: 10.1089/neu.1998.15.573.'}, {'pmid': '27045637', 'type': 'BACKGROUND', 'citation': 'Cossu G, Messerer M, Stocchetti N, Levivier M, Daniel RT, Oddo M. Intracranial pressure and outcome in critically ill patients with aneurysmal subarachnoid hemorrhage: a systematic review. Minerva Anestesiol. 2016 Jun;82(6):684-96. Epub 2016 Apr 5.'}, {'pmid': '25689123', 'type': 'BACKGROUND', 'citation': 'Citerio G, Oddo M, Taccone FS. Recommendations for the use of multimodal monitoring in the neurointensive care unit. Curr Opin Crit Care. 2015 Apr;21(2):113-9. doi: 10.1097/MCC.0000000000000179.'}, {'pmid': '23320763', 'type': 'BACKGROUND', 'citation': 'Stocchetti N, Le Roux P, Vespa P, Oddo M, Citerio G, Andrews PJ, Stevens RD, Sharshar T, Taccone FS, Vincent JL. Clinical review: neuromonitoring - an update. Crit Care. 2013 Jan 15;17(1):201. doi: 10.1186/cc11513.'}, {'pmid': '36622462', 'type': 'DERIVED', 'citation': 'Robba C, Graziano F, Guglielmi A, Rebora P, Galimberti S, Taccone FS, Citerio G; SYNAPSE-ICU Investigators. Treatments for intracranial hypertension in acute brain-injured patients: grading, timing, and association with outcome. Data from the SYNAPSE-ICU study. Intensive Care Med. 2023 Jan;49(1):50-61. doi: 10.1007/s00134-022-06937-1. Epub 2023 Jan 9.'}, {'pmid': '35508390', 'type': 'DERIVED', 'citation': 'Dallagiacoma S, Robba C, Graziano F, Rebora P, Hemphill JC, Galimberti S, Citerio G; SYNAPSE-ICU Investigators. Intracranial Pressure Monitoring in Patients With Spontaneous Intracerebral Hemorrhage: Insights From the SYNAPSE-ICU Study. Neurology. 2022 Jul 12;99(2):e98-e108. doi: 10.1212/WNL.0000000000200568. Epub 2022 May 4.'}, {'pmid': '34146513', 'type': 'DERIVED', 'citation': 'Robba C, Graziano F, Rebora P, Elli F, Giussani C, Oddo M, Meyfroidt G, Helbok R, Taccone FS, Prisco L, Vincent JL, Suarez JI, Stocchetti N, Citerio G; SYNAPSE-ICU Investigators. Intracranial pressure monitoring in patients with acute brain injury in the intensive care unit (SYNAPSE-ICU): an international, prospective observational cohort study. Lancet Neurol. 2021 Jul;20(7):548-558. doi: 10.1016/S1474-4422(21)00138-1.'}, {'pmid': '31005932', 'type': 'DERIVED', 'citation': 'Citerio G, Prisco L, Oddo M, Meyfroidt G, Helbok R, Stocchetti N, Taccone F, Vincent JL, Robba C, Elli F, Sala E, Vargiolu A, Lingsma H. International prospective observational study on intracranial pressure in intensive care (ICU): the SYNAPSE-ICU study protocol. BMJ Open. 2019 Apr 20;9(4):e026552. doi: 10.1136/bmjopen-2018-026552.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.\n\nThe 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.\n\nSample 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.\n\nInclusion Criteria:\n\n* Acute brain injury (ABI) admitted to ICU following:\n\n 1. Hemorrhagic stroke, including intracerebral hematoma and subarachnoid hemorrhage,\n 2. Traumatic brain injury (penetrating and non-penetrating).\n* Age \\>18 years old\n* 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\n\nExclusion Criteria:\n\n* ABI who are not admitted to ICU;\n* ABI due to infections of the central nervous system, ischemic stroke or other causes not defined in the inclusion criteria\n\nOutcome measures:\n\nGlasgow Outcome Score-Extended at 6 months\n\nEndpoint:\n\nThe primary endpoint is the variation in clinical practice around ICP monitoring in acute brain injury patients.\n\nScreening and recruitment: 12 weeks at each centre, or the duration required to enrol 90 patients per centre.\n\nFollow-up: outcome measures will be collected at 6 months.\n\nDuration of study: 2 years.\n\nThe SYNAPSE-ICU study is partly funded by ESICM (ESICM Trials Group Portfolio).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hemorrhagic stroke, including intracerebral hematoma and subarachnoid hemorrhage, Traumatic brain injury', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\> 18 years;\n2. Diagnosis of an acute brain injury (ABI) due to primary hemorrhagic stroke (including intracranial hemorrhage or subarachnoid hemorrhage) or traumatic brain injury;\n3. 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.\n\nExclusion Criteria:\n\n1. Acute Brain Injury (ABI) who are not admitted to ICU;\n2. ABI due to infections of the central nervous system, ischaemic stroke or other causes not defined in the inclusion criteria.'}, 'identificationModule': {'nctId': 'NCT03257904', 'acronym': 'SynapseICU', 'briefTitle': 'iNtrAcranial PreSsurE in Intensive Care (ICU) (SynapseICU)', 'organization': {'class': 'OTHER', 'fullName': 'University of Milano Bicocca'}, 'officialTitle': 'International Prospective Observational StudY on iNtrAcranial PreSsurE in Intensive Care (ICU) (SynapseICU)', 'orgStudyIdInfo': {'id': 'SynapseICU'}}, 'armsInterventionsModule': {'interventions': [{'name': 'intracranial pressure monitoring', 'type': 'PROCEDURE', 'description': 'measurement of intracranial pressure'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20900', 'city': 'Monza', 'state': 'MB', 'country': 'Italy', 'facility': 'ASST-Monza', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}], 'overallOfficials': [{'name': 'Giuseppe Citerio', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Milano Bicocca'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milano Bicocca', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Society of Intensive Care Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Giuseppe Citerio, MD', 'investigatorAffiliation': 'University of Milano Bicocca'}}}}