protocolSection identificationModule nctId: NCT06270615, orgStudyIdInfo id: CRCBDD1712, briefTitle: Prospective Validation of the SHOCKMATRIX Hemorrhage Predictive Model, acronym: SHOCKMATRIX, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-07-01, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, collaborators name: Traumabase Group, collaborators name: Capgemini Invent, collaborators name: Ecole polytechnique, collaborators name: EHESS (Ecole des hautes études en sciences sociales), collaborators name: CNRS (Centre national de la recherche scientifique), descriptionModule briefSummary: Management of post-traumatic severe hemorrhage remains a challenge to any trauma care system. Studying integrated and innovative tools designed to predict the risk of early severe hemorrhage (ESH) and resource needs could offer a promising option to improve clinical decisions and then shorten the time of intervention in the context of pre-hospital severe trauma. As evidence seems to be lacking to address this issue, this ambispective validation study proposes to assess on an independent cohort the predictive performance of a newly developed machine learning-based model, as well as the feasibility of its clinical deployment under real-time healthcare conditions., conditionsModule conditions: Wounds and Injuries, conditions: Traumatic Shock, conditions: Hemorrhagic Shock, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: OTHER, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Ambispective validation of machine learning-based predictive model, outcomesModule primaryOutcomes measure: Fβ-score, with β = 4, secondaryOutcomes measure: Common binary classification metrics, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Beaujon Hospital AP-HP, Anesthesia-Intensive Care Department, status: RECRUITING, city: Clichy, zip: 92110, country: France, contacts name: Mathilde Holleville, MD, role: CONTACT, email: mathilde.holleville@aphpr.fr, geoPoint lat: 48.90018, lon: 2.30952, locations facility: Grenoble Alpes University Hospital, status: RECRUITING, city: La Tronche, zip: 38700, country: France, contacts name: Tobias Gauss, MD, role: CONTACT, phone: +33476769288, email: tgauss@chu-grenoble.fr, contacts name: Samia Salah, role: CONTACT, phone: +33476769288, email: SSalah1@chu-grenoble.fr, geoPoint lat: 45.20429, lon: 5.73645, locations facility: Bicêtre Hospital AP-HP, Anesthesia-Intensive Care Department, status: RECRUITING, city: Le Kremlin-Bicêtre, zip: 94270, country: France, contacts name: Marie Werner, MD, role: CONTACT, email: marie.werner@aphp.fr, geoPoint lat: 48.81471, lon: 2.36073, locations facility: Lille University Hospital, Anaesthesia and Intensive Care Unit, status: RECRUITING, city: Lille, zip: 59037, country: France, contacts name: Benjamin Bijok, MD, role: CONTACT, email: Benjamin.BIJOK@CHRU-LILLE.FR, geoPoint lat: 50.63297, lon: 3.05858, locations facility: Pitié-Salpêtrière Hospital AP-HP, Anesthesia-Intensive Care Department, status: RECRUITING, city: Paris, zip: 75013, country: France, contacts name: Arthur James, MD, role: CONTACT, email: arthur.james@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Georges-Pompidou European Hospital AP-HP, Anesthesia-Intensive Care Department, status: RECRUITING, city: Paris, zip: 75015, country: France, contacts name: Nathalie Delhaye, MD, role: CONTACT, email: nathalie.delhaye@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, locations facility: University Hospitals Strasbourg, Anaesthesia, Intensive Care and Peri-Operative Medicine Department, status: RECRUITING, city: Strasbourg, zip: 67200, country: France, contacts name: Alain Meyer, MD, role: CONTACT, email: alain.meyer@chru-strasbourg.fr, geoPoint lat: 48.58392, lon: 7.74553, locations facility: University Hospital of Toulouse, Polyvalent Intensive Care, status: RECRUITING, city: Toulouse, zip: 31059, country: France, contacts name: Véronique Ramonda, MD, role: CONTACT, email: ramonda.v@chu-toulouse.fr, geoPoint lat: 43.60426, lon: 1.44367, hasResults: False