Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2026-02-13 @ 6:58 AM
Study NCT ID:
NCT03143751
Status:
COMPLETED
Last Update Posted:
2020-12-08
First Post:
2017-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Hyperosomolar Therapy for Traumatic Brain-injured Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Masking: Open label , Masked Roles: Subject and Outcomes assessor'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 370}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-04', 'studyFirstSubmitDate': '2017-04-28', 'studyFirstSubmitQcDate': '2017-05-04', 'lastUpdatePostDateStruct': {'date': '2020-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Score on the Extended Glasgow Outcome Scale (GOS-E) at 6 months', 'timeFrame': '6 months', 'description': 'The GOS-E is a scale measuring the neurological recovery after traumatic brain injuries'}], 'secondaryOutcomes': [{'measure': 'Mortality rate in ICU', 'timeFrame': '3 months'}, {'measure': 'Mortality rate in ICU', 'timeFrame': '6 months'}, {'measure': 'GOS-E', 'timeFrame': '3 months', 'description': 'The GOS-E is a scale measuring the neurological recovery after traumatic brain injuries'}, {'measure': 'functional independence measure : ADL (Activities of Daily Living) of Katz', 'timeFrame': '3 months', 'description': 'Scale measuring the autonomy of patient'}, {'measure': 'functional independence measure : ADL (Activities of Daily Living) of Katz', 'timeFrame': '6 months', 'description': 'Scale measuring the autonomy of patient'}, {'measure': 'Short Form 36', 'timeFrame': '3 months', 'description': 'Scale measuring the quality of life'}, {'measure': 'Short Form 36', 'timeFrame': '6 months', 'description': 'Scale measuring the quality of life'}, {'measure': 'Rate of patients with anterograde amnesia', 'timeFrame': '3 months'}, {'measure': 'Rate of patients with anterograde amnesia', 'timeFrame': '6 months'}, {'measure': 'Intracranial pressure control', 'timeFrame': '7 Days'}, {'measure': 'Blood level of sodium', 'timeFrame': '7 Days'}, {'measure': 'blood osmolality', 'timeFrame': '7 Days'}, {'measure': 'Rate of thrombo-embolic events', 'timeFrame': '28 days'}, {'measure': 'Rate of acute kidney injury', 'timeFrame': '28 days', 'description': 'KDIGO 3'}, {'measure': 'Rate of centropontine myelinolysis', 'timeFrame': '28 days', 'description': 'Diagnosis on MRI realized in case of clinical suspicion'}, {'measure': 'Blood level of chlore', 'timeFrame': '7 Days'}, {'measure': 'Blood level of potassium', 'timeFrame': '5 Days'}, {'measure': 'Blood level of pH (Hydrogen Potention)', 'timeFrame': '5 Days'}, {'measure': 'brain oxygenation (PtiO2)', 'timeFrame': '5 Days'}, {'measure': 'blood level of creatinine', 'timeFrame': '5 Days'}, {'measure': 'Diuresis', 'timeFrame': '5 Days'}, {'measure': 'weight', 'timeFrame': '5 Days'}, {'measure': "Ancillary study: questionnaire HADS (Hospital Anxiety and Depression Scale) in patient's relative", 'timeFrame': '6 months', 'description': 'Scale measuring the quality of life'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Moderate to Severe Traumatic Brain Injury']}, 'referencesModule': {'references': [{'pmid': '36707841', 'type': 'DERIVED', 'citation': "Huet O, Chapalain X, Vermeersch V, Moyer JD, Lasocki S, Cohen B, Dahyot-Fizelier C, Chalard K, Seguin P, Hourmant Y, Asehnoune K, Roquilly A; Atlanrea Study Group and the Societe Francaise d'Anesthesie Reanimation (SFAR) Research Network. Impact of continuous hypertonic (NaCl 20%) saline solution on renal outcomes after traumatic brain injury (TBI): a post hoc analysis of the COBI trial. Crit Care. 2023 Jan 27;27(1):42. doi: 10.1186/s13054-023-04311-1."}, {'pmid': '34032829', 'type': 'DERIVED', 'citation': "Roquilly A, Moyer JD, Huet O, Lasocki S, Cohen B, Dahyot-Fizelier C, Chalard K, Seguin P, Jeantrelle C, Vermeersch V, Gaillard T, Cinotti R, Demeure Dit Latte D, Mahe PJ, Vourc'h M, Martin FP, Chopin A, Lerebourg C, Flet L, Chiffoleau A, Feuillet F, Asehnoune K; Atlanrea Study Group and the Societe Francaise d'Anesthesie Reanimation (SFAR) Research Network. Effect of Continuous Infusion of Hypertonic Saline vs Standard Care on 6-Month Neurological Outcomes in Patients With Traumatic Brain Injury: The COBI Randomized Clinical Trial. JAMA. 2021 May 25;325(20):2056-2066. doi: 10.1001/jama.2021.5561."}, {'pmid': '28947465', 'type': 'DERIVED', 'citation': 'Roquilly A, Lasocki S, Moyer JD, Huet O, Perrigault PF, Dahyot-Fizelier C, Seguin P, Sharshar T, Geeraerts T, Remerand F, Feuillet F, Asehnoune K; COBI group. COBI (COntinuous hyperosmolar therapy for traumatic Brain-Injured patients) trial protocol: a multicentre randomised open-label trial with blinded adjudication of primary outcome. BMJ Open. 2017 Sep 24;7(9):e018035. doi: 10.1136/bmjopen-2017-018035.'}]}, 'descriptionModule': {'briefSummary': 'Traumatic brain injury (TBI) is a major cause of death and severe prolonged disability. Intracranial hypertension (ICH) is a critical risk factor of bad outcomes after TBI. Continuous infusion of hyperosmolar therapy has been proposed for the prevention or the treatment of ICH. Whether an early administration of continuous hyperosmolar therapy improves long term outcomes is uncertain. The aim of the current study is to assess the efficiency and the safety of continuous hyperosmolar therapy in TBI patients.\n\nThe COBI trial is the first randomized controlled trial powered to investigate whether continuous hyperosmolar therapy in TBI patients improve long term recovery.\n\nHypothesis\n\nPatients treated with early continuous hyperosmolar therapy have reduced morbidity and mortality rates compared to those receiving standard care alone after traumatic brain injury.\n\nResearch Questions\n\n1. Does early continuous hyperosmolar therapy reduce morbidity and mortality rates at 3 and 6 months after TBI assessed by the GOSE questionnaire?\n2. Does early continuous hyperosmolar therapy prevent intracranial hypertension?', 'detailedDescription': 'Background Traumatic brain injury (TBI) is a major cause of death and severe prolonged disability. Intracranial hypertension (ICH) is a critical risk factor of bad outcomes after TBI.\n\nContinuous infusion of hyperosmolar therapy has been proposed for the prevention or the treatment of ICH. Whether an early administration of continuous hyperosmolar therapy improves long term outcomes is uncertain. The aim of the current study is to assess the efficiency and the safety of continuous hyperosmolar therapy in TBI patients.\n\nMethods The COBI (Continuous hyperosmolar therapy in traumatic brain-injured patients) trial is a multicenter, randomized, controlled, open-label, two-arms study with blinded adjudication of primary outcome. Three hundred and seventy patients hospitalized in Intensive Care Unit with a traumatic brain injury (Glasgow Coma Scale ≤ 12 and abnormal brain CT-scan) are randomized in the first 24 hours following trauma to standard care or continuous hyperosmolar therapy (NaCl 20%) plus standard care. Continuous hyperosmolar therapy is maintained for at least 48 hours in the treatment group and continued for as long as is necessary to prevent intracranial hypertension. The primary outcome is the score on the Extended Glasgow Outcome Scale (GOS-E) at 6 months. The treatment effect is estimated with ordinal logistic regression adjusted for pre-specified prognostic factors and expressed as a common odds ratio.\n\nDiscussion The COBI trial is the first randomized controlled trial powered to investigate whether continuous hyperosmolar therapy in TBI patients improve long term recovery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-80 years old\n* Moderate to severe traumatic brain injury defined as the association of a Coma Glasgow Scale ≤ 12 together with a traumatic abnormal brain CT-scan\n* Time to inclusion inferior to 24 hours\n* Informed consent (or emergency procedure)\n\nExclusion Criteria:\n\n* dependence for daily activity\n* Coma Glasgow Scale of 3 and fixed dilated pupils\n* associated cervical spine injury\n* imminent death and do-not-resuscitate orders\n* pregnancy.\n* Major not legally responsible\n* Oedemato-ascitic decompensation of hepatic cirrhosis\n* State of hydro-sodium retention secondary to heart failure'}, 'identificationModule': {'nctId': 'NCT03143751', 'acronym': 'COBI', 'briefTitle': 'Continuous Hyperosomolar Therapy for Traumatic Brain-injured Patients', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Continuous Hyperosomolar Therapy for Traumatic Brain-injured Patients Study Protocol for a Multicenter Randomized Open-label Trial With Blinded Adjudication of Primary Outcome', 'orgStudyIdInfo': {'id': 'RC16_0474'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continuous hyperosmolar therapy', 'description': 'Standard cares plus continuous hyperosmolar therapy (NaCl20%)', 'interventionNames': ['Drug: NaCl20% (Continuous hyperosmolar therapy)']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard cares alone.'}], 'interventions': [{'name': 'NaCl20% (Continuous hyperosmolar therapy)', 'type': 'DRUG', 'description': 'Early intravenous administration (\\<24 hours after traumatic brain injury) of NaCl20% for a minimal duration of 48 hours (continued for as long as is necessary to prevent intracranial hypertension)\n\n1-hour bolus (15 g if Na+ \\< 145 mmol/L; 7.5 g if 145 \\< Na+ \\< 150 mmol/L; or no bolus) followed by 1 g/hour as long as Na+\\< 150 mmol/L, reduced to 0.5 g/L if 150 \\< Na+ \\< 155 mmol/L, Discontinuation when 155 mmol/L\\<Na+', 'armGroupLabels': ['Continuous hyperosmolar therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '29600', 'city': 'Brest', 'country': 'France', 'facility': 'CHU Brest Hopital La Cavale Blanche', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '92118', 'city': 'Clichy', 'country': 'France', 'facility': 'AP-HP Beaujon', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'city': 'Montpellier', 'country': 'France', 'facility': 'CHU Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Centre Hospitalier Sainte-Anne', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'city': 'Rennes', 'country': 'France', 'facility': 'CHU Rennes-Hopital Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse Hôpital Pierre-Paul Riquet', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'CHU Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Olivier Huet, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Brest'}, {'name': 'Lasocki Sigismond, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Angers'}, {'name': 'Thomas Geerraerts, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}, {'name': 'Francis Remerand, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Tours'}, {'name': 'Philippe Seguin, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rennes University Hospital'}, {'name': 'Claire Dahyot, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Poitiers'}, {'name': 'Pierre François Perrigault, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}, {'name': 'Jean Denis Moyer, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AP-HP Beaujon'}, {'name': 'Tarek SHARSHAR, PU-PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AP-HP Saint-Anne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}