[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631883":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":289,"collaborators":26,"id":291,"slug":292,"hasResults":293,"nctId":294,"briefTitle":295,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":293,"sex":298,"minAge":299,"maxAge":26,"enrollmentInfo":300,"targetDuration":26,"studyType":303,"phases":304,"briefSummary":306,"conditions":307,"keywords":310,"overallStatus":314,"whyStopped":26,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":324},{"fullName":5,"class":6},"University Hospital, Grenoble","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Dose LMWH","ACTIVE_COMPARATOR","Patients in the control group receive a standard dose of enoxaparin during 14 days. They will receive two injections per day, one of them being a placebo.",[13],"Drug: Enoxaparin standard dose",{"label":15,"type":16,"description":17,"interventionNames":18},"Intermediate Dose LMWH","EXPERIMENTAL","Patients in the experimental group receive a intermediate dose of enoxparin. They receive two injections of enoxaparin per day.",[19],"Drug: Enoxaparin intermediate dose",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Enoxaparin standard dose","In the control group, patients will receive 1 injection of enoxaparin 4000 IU and 1 injection of placebo until day 14 or hospital discharge in the same form as enoxaparin (subcutaneous injection).\n\nA placebo injection is administered as needed to maintain blinding and ensure the same number of injections as in the intermediate-dose arm.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Enoxaparin intermediate dose","In the experimental group, patients will receive 2 injections of enoxaparin 4000 IU until day 14 or hospital discharge.",[15],[32],{"name":33,"affiliation":34,"role":35},"Alexandre GODON","CHU Grenoble Alpes","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+33 4 76 76 75 75","agodon1@chu-grenoble.fr",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Juliana BENY","+33 4 76 76 79 55","JBeny@chu-grenoble.fr",[46,64,79,94,106,121,136,151,163,178,193,208,223,235,250,265,280],{"facility":47,"status":26,"city":48,"state":26,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"CHU Angers","Angers","49100","France","FR",{"type":53,"coordinates":54},"Point",[55,56],-0.55202,47.47156,{"lat":56,"lon":55},[59,63],{"name":60,"role":38,"phone":61,"phoneExt":26,"email":62},"Sigismond LASOCKI","+33 2 41 35 36 35","silasocki@chu-angers.fr",{"name":60,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":65,"status":26,"city":66,"state":26,"zip":67,"country":50,"countryCode":51,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"CHU Clermont Ferrand","Clermont-Ferrand","63000",{"type":53,"coordinates":69},[70,71],3.08682,45.77969,{"lat":71,"lon":70},[74,78],{"name":75,"role":38,"phone":76,"phoneExt":26,"email":77},"Benjamin RIEU","+33 4 73 75 41 56","brieu@chu-clermontferrand.fr",{"name":75,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":80,"status":26,"city":81,"state":26,"zip":82,"country":50,"countryCode":51,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Hôpital Beaujon AP-HP","Clichy","92110",{"type":53,"coordinates":84},[85,86],2.30952,48.90018,{"lat":86,"lon":85},[89,93],{"name":90,"role":38,"phone":91,"phoneExt":26,"email":92},"Charles BERNARD","+33 1 40 87 50 81","charles.bernard@aphp.fr",{"name":90,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":34,"status":26,"city":95,"state":26,"zip":96,"country":50,"countryCode":51,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Grenoble","38000",{"type":53,"coordinates":98},[99,100],5.71479,45.17869,{"lat":100,"lon":99},[103,104,105],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":107,"status":26,"city":108,"state":26,"zip":109,"country":50,"countryCode":51,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"AP-HP Bicêtre","Le Kremlin-Bicêtre","94270",{"type":53,"coordinates":111},[112,113],2.36073,48.81471,{"lat":113,"lon":112},[116,120],{"name":117,"role":38,"phone":118,"phoneExt":26,"email":119},"Inaame ETTOUMI","+33 1 45 21 25 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86","anne-claire.lukaszewicz@chu-lyon.fr",{"name":147,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":152,"status":26,"city":138,"state":26,"zip":153,"country":50,"countryCode":51,"cosmosGeoPoint":154,"geoPoint":156,"contacts":157},"HCL Lyon Sud","69310",{"type":53,"coordinates":155},[142,143],{"lat":143,"lon":142},[158,162],{"name":159,"role":38,"phone":160,"phoneExt":26,"email":161},"Jean Stéphane DAVID","+33 4 78 86 41 40","jean-stephane.david@chu-lyon.fr",{"name":159,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":164,"status":26,"city":165,"state":26,"zip":166,"country":50,"countryCode":51,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Assistance Publique - Hôpitaux de Marseille","Marseille","13005",{"type":53,"coordinates":168},[169,170],5.38107,43.29695,{"lat":170,"lon":169},[173,177],{"name":174,"role":38,"phone":175,"phoneExt":26,"email":176},"Gary DUCLOS","+33 4 91 96 55 31","GARY.DUCLOS@ap-hm.fr",{"name":174,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":179,"status":26,"city":180,"state":26,"zip":181,"country":50,"countryCode":51,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"CHU Montpellier","Montpellier","34080",{"type":53,"coordinates":183},[184,185],3.87635,43.61093,{"lat":185,"lon":184},[188,192],{"name":189,"role":38,"phone":190,"phoneExt":26,"email":191},"Pauline DERAS","+33 4 67 33 82 57","p-deras@chu-montpellier.fr",{"name":189,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":194,"status":26,"city":195,"state":26,"zip":196,"country":50,"countryCode":51,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"CHU Nantes","Nantes","44000",{"type":53,"coordinates":198},[199,200],-1.55336,47.21725,{"lat":200,"lon":199},[203,207],{"name":204,"role":38,"phone":205,"phoneExt":26,"email":206},"Yannick HOURMANT","+33 2 40 08 73 80","yannick.hourmant@chu-nantes.fr",{"name":204,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":209,"status":26,"city":210,"state":26,"zip":211,"country":50,"countryCode":51,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"Hôpital Pitié-Salpêtrière APHP","Paris","75013",{"type":53,"coordinates":213},[214,215],2.3488,48.85341,{"lat":215,"lon":214},[218,222],{"name":219,"role":38,"phone":220,"phoneExt":26,"email":221},"Pauline GLASMAN","+33 1 84 82 71 17","pauline.glasman@aphp.fr",{"name":219,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":224,"status":26,"city":210,"state":26,"zip":225,"country":50,"countryCode":51,"cosmosGeoPoint":226,"geoPoint":228,"contacts":229},"Hôpital Européen Georges Pompidou AP-HP","75015",{"type":53,"coordinates":227},[214,215],{"lat":215,"lon":214},[230,234],{"name":231,"role":38,"phone":232,"phoneExt":26,"email":233},"Anne GODIER","+33 1 56 09 25 84","anne.godier@aphp.fr",{"name":231,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":236,"status":26,"city":237,"state":26,"zip":238,"country":50,"countryCode":51,"cosmosGeoPoint":239,"geoPoint":243,"contacts":244},"CHU Rennes","Rennes","35000",{"type":53,"coordinates":240},[241,242],-1.67431,48.11109,{"lat":242,"lon":241},[245,249],{"name":246,"role":38,"phone":247,"phoneExt":26,"email":248},"Yoann LAUNEY","+33 2 99 28 24 22","yoann.launey@chu-rennes.fr",{"name":246,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":251,"status":26,"city":252,"state":26,"zip":253,"country":50,"countryCode":51,"cosmosGeoPoint":254,"geoPoint":258,"contacts":259},"CHU Strasbourg","Strasbourg","67200",{"type":53,"coordinates":255},[256,257],7.74553,48.58392,{"lat":257,"lon":256},[260,264],{"name":261,"role":38,"phone":262,"phoneExt":26,"email":263},"Julien POTTECHER","+33 3 88 12 70 95","julien.pottecher@chru-strasbourg.fr",{"name":261,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":266,"status":26,"city":267,"state":26,"zip":268,"country":50,"countryCode":51,"cosmosGeoPoint":269,"geoPoint":273,"contacts":274},"CHU de Toulouse","Toulouse","31300",{"type":53,"coordinates":270},[271,272],1.44367,43.60426,{"lat":272,"lon":271},[275,279],{"name":276,"role":38,"phone":277,"phoneExt":26,"email":278},"Véronique ROMANDA","+33 6 43 56 44 07","ramonda.v@chu-toulouse.fr",{"name":276,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":281,"status":26,"city":282,"state":26,"zip":283,"country":50,"countryCode":51,"cosmosGeoPoint":284,"geoPoint":288,"contacts":26},"CHU Tours","Tours","37000",{"type":53,"coordinates":285},[286,287],0.70398,47.39484,{"lat":287,"lon":286},{"type":290,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100631883","intermediate-versus-standard-dose-enoxaparin-to-prevent-venous-thromboembolism-in-severe-trauma-patients-a-multicenter-double-blind-randomised-controlled-trial-100631883",false,"NCT07506473","Intermediate Versus Standard Dose Enoxaparin to Prevent Venous Thromboembolism in Severe Trauma Patients: a Multicenter Double Blind Randomised Controlled Trial","HEPTRAUMA","Inclusion Criteria:\n\n* All adult patients (age ≥18 years) admitted to an intensive care unit following trauma with an expected stay \\>48 hours and a planned administration of LMWH.\n* Affiliation to the French social security system or European (CEAM)\n\nExclusion Criteria:\n\n* Prehospital cardiac arrest\n* Hospital admission \\>72 hours\n* More than one dose of prophylactic anticoagulant already administered since trauma\n* Renal failure defined by creatinine clearance of 30 mL\u002Fmin or less (Cockcroft-Gault formula)\n* Body weight \\>100 kg or \\\u003C45 kg\n* Indication for therapeutic anticoagulation\n* Major known thrombophilia (e.g. antiphospholipid syndrome, antithrombin deficiency)\n* Constitutional bleeding disorder (haemophilia, von Willebrand disease, coagulation factor deficiency, platelet disorder).\n* Thrombocytopenia inferior to 50 G.L-1\n* History of heparin-induced thrombocytopenia\n* Study drug hypersensitivity\n* Limitation of life support, life expectancy ≤7 days or palliative care\n* Contraindication to the administration of anticoagulant according to the SPC (Active clinically significant bleeding or a condition associated with a high risk of bleeding, such as a recent haemorrhagic stroke, gastrointestinal ulcer, the presence of a malignant tumour at high risk of bleeding, recent brain, spinal or ophthalmological surgery, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intrarachid or intracerebral vascular anomalies.)\n* pregnant or breastfeeding woman\n* Inclusion in another experimental trial\n* Protected person (art. L1121-5 to L1121-8 of the CSP or art. 31 to 35 of European regulation 536\u002F2014)","ALL","18 Years",{"count":301,"type":302},540,"ESTIMATED","INTERVENTIONAL",[305],"NA","Venous thromboembolism is a frequent issue in severe trauma patients. Guidelines for venous thromboembolism prevention include the use of pharmacological thromboprophylaxis, mainly with low-molecular-weight heparin, and\u002For mechanical thromboprophylaxis. However, a high incidence of venous thromboembolism is observed despite standard dose thromboprophylaxis (such as enoxaparin 40 mg once daily).\n\nAn increase of the dose of anticoagulants could improve thromboprophylaxis in trauma patients. To date, two randomised trials have assessed the effect of weight-based low-molecular-weight heparin dosing vs. fixed dose in trauma patients. These pilot studies did not demonstrate a statistical difference between groups although there was a trend in favour of a lower incidence of deep vein thromboses with the increased dose low-molecular-weight heparin prophylaxis. However, both studies included non-severe trauma patients and the second study focused only on deep vein thromboses. Other studies suggested that a superior-than-standard dose of low-molecular-weight heparin, sometimes\n\nguided by the anti-Xa activity, decreases the incidence of venous thromboembolism in severe trauma without increasing bleeding events, but they were observational in nature.\n\nThe hypothesis of the HEPTRAUMA trial is that, in severe trauma patients, a thromboprophylaxis with intermediate dose low-molecular-weight heparin (twice the standard dose) decreases the incidence of major venous thromboembolism compared to standard dose.",[308,309],"Severe Trauma Patient","Venous Thromboembolism",[311,312,313],"Thromboprophylaxis","Severe trauma","Anticoagulant","NOT_YET_RECRUITING","2026-04-23",{"date":317,"type":318},"2026-04-29","ACTUAL",{"date":320,"type":302},"2026-04",{"date":322,"type":302},"2028-05",{"name":5,"class":6},17]