[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644438":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":34,"locations":43,"responsibleParty":125,"collaborators":25,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":129,"sex":135,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":25,"studyType":141,"phases":142,"briefSummary":144,"conditions":145,"keywords":148,"overallStatus":152,"whyStopped":25,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"University Hospital, Tours","OTHER",[8,15],{"label":9,"type":6,"description":10,"interventionNames":11},"ASA + local NSAID then placebo + local NSAIDs","This is a cross-over design. Patients randomized in this sequence will receive ASA + local NSAIDs during their first flare-up, then placebo + local NSAIDs during their second flare-up (with a wash out period of two weeks).",[12,13,14],"Drug: AAS at anti-inflammatory doses from 3 days to 14 days.","Drug: Placebo from 3 days to 14 days.","Drug: Application of Diclofenac gel 1% twice a day",{"label":16,"type":6,"description":17,"interventionNames":18},"Placebo + local NSAID then AAS + local NSAIDs","This is a cross-over design. Patients randomized in this sequence will receive placebo + local NSAIDs during their first flare-up, then AAS + local NSAIDs during their second flare-up (with a wash out period of two weeks).",[12,13,14],[20,26,30],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","AAS at anti-inflammatory doses from 3 days to 14 days.","AAS at anti-inflammatory doses administered orally for a minimum of 3 days and a maximum of 14 days. Orally administered AAS is combined with the application of 1% diclofenac gel (NSAID) twice a day.",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo from 3 days to 14 days.","Placebo administered orally for a minimum of 3 days and a maximum of 14 days. Oral placebo is combined with the application of 1% diclofenac gel (NSAID) twice a day.",[9,16],{"type":21,"name":31,"description":32,"armGroupLabels":33,"otherNames":25},"Application of Diclofenac gel 1% twice a day","Application of 1% diclofenac gel (NSAID) twice a day.",[9,16],[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Sophie LEDUCQ, MD, PhD","CONTACT","+332 47 47 56 02","S.LEDUCQ@chu-tours.fr",{"name":41,"role":37,"phone":25,"phoneExt":25,"email":42},"Coralie TAILLEBUIS","cpcq@chu-tours.fr",[44,60,73,86,99,112],{"facility":45,"status":25,"city":46,"state":25,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Centre Hospitalier Universitaire d'Angers","Angers","France","FR",{"type":50,"coordinates":51},"Point",[52,53],-0.55202,47.47156,{"lat":53,"lon":52},[56],{"name":57,"role":37,"phone":58,"phoneExt":25,"email":59},"Ludovic MARTIN","+332 41 35 34 19","lumartin@chu-angers.fr",{"facility":61,"status":25,"city":62,"state":25,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Centre Hospitalier Universitaire de Brest","Brest",{"type":50,"coordinates":64},[65,66],-4.48628,48.39029,{"lat":66,"lon":65},[69],{"name":70,"role":37,"phone":71,"phoneExt":25,"email":72},"Claire ABASQ-THOMAS","+332 98 22 33 15","claire.abasq@chu-brest.fr",{"facility":74,"status":25,"city":75,"state":25,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"AP-HM","Marseille",{"type":50,"coordinates":77},[78,79],5.38107,43.29695,{"lat":79,"lon":78},[82],{"name":83,"role":37,"phone":84,"phoneExt":25,"email":85},"Stéphanie MALLET","+334 91 38 88 01","Stephanie.MALLET@ap-hm.fr",{"facility":87,"status":25,"city":88,"state":25,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Centre Hospitalier Universitaire de Nantes","Nantes",{"type":50,"coordinates":90},[91,92],-1.55336,47.21725,{"lat":92,"lon":91},[95],{"name":96,"role":37,"phone":97,"phoneExt":25,"email":98},"Sébastien BARBAROT, MD","+332 40 08 40 86","sebastien.barbarot@chu-nantes.fr",{"facility":100,"status":25,"city":101,"state":25,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"AP-HP","Paris",{"type":50,"coordinates":103},[104,105],2.3488,48.85341,{"lat":105,"lon":104},[108],{"name":109,"role":37,"phone":110,"phoneExt":25,"email":111},"Olivia BOCCARA","+331 44 49 46 63","olivia.boccara@aphp.fr",{"facility":113,"status":25,"city":114,"state":25,"zip":25,"country":47,"countryCode":48,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Centre Hospitalier Universitaire de Rennes","Rennes",{"type":50,"coordinates":116},[117,118],-1.67431,48.11109,{"lat":118,"lon":117},[121],{"name":122,"role":37,"phone":123,"phoneExt":25,"email":124},"Catherine DROITCOURT","+332 99 28 98 89","catherine.droitcourt@chu-rennes.fr",{"type":126,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100644438","phase-2-acetylsalicylic-acid-versus-placebo-as-an-add-on-treatment-to-local-non-steroidal-anti-inflammatory-drug-for-the-management-of-thrombotic-episodes-in-superficial-venous-malformations-in-children-aged-6-to-17-years-100644438",false,"NCT07663825","Acetylsalicylic Acid Versus Placebo as an add-on Treatment to Local Non-steroidal Anti-inflammatory Drug for the Management of Thrombotic Episodes in Superficial Venous Malformations in Children Aged 6 to 17 Years.","Acetylsalicylic Acid Versus Placebo as an add-on Treatment to Local Non-steroidal Anti-inflammatory Drug for the Management of Thrombotic Episodes in Superficial Venous Malformations in Children Aged 6 to 17 Years: a Controlled Randomised, Double-blind, Cross-over, Multicenter Trial","ASPIRIN","Inclusion Criteria:\n\n* Patients aged 6 to 17 years\n* Weight ≥ 20 kg\n* Isolated or combined superficial venous malformation, confirmed by imaging, with the presence of phleboliths indicating the occurrence of previous superficial venous thrombosis\n* Complicated by acute thrombotic episodes (2 or more in the previous 12 months)\n* Written consent of the child's legal representatives or of the participant if over 18 years of age\n* Affiliation of a social security scheme\n* Highly effective contraception for young women of childbearing age\n\nExclusion Criteria:\n\n* Patients with deep or syndromic venous malformation\n* Patients with known G6PD deficiency\n* Patients with known mastocytosis\n* History of hemarthrosis\n* Simultaneous participation in another biomedical study\n* Constitutional or acquired haemostasis pathology\n* Current treatment affecting haemostasis (anticoagulants, platelet anti aggregants, oral NSAIDs)\n* Frequent bleeding (epistaxis, other) requiring management\n* Basic treatment of venous malformation (mTOR inhibitor)\n* Active neoplasia or infection (altered coagulation balance)\n* Known allergy to acetylsalicylic acid\n* Injured skin, whatever the lesion: oozing dermatitis, eczema, infected lesions, burns or wounds\n* Pregnant and breastfeeding women\n* Severe renal insufficiency, severe hepatic insufficiency, severe uncontrolled cardiac insufficiency\n* Methotrexate ≥ 20 mg\u002Fweek","ALL","6 Years","17 Years",{"count":139,"type":140},34,"ESTIMATED","INTERVENTIONAL",[143],"PHASE2","Superficial venous malformations (SVMs) are rare congenital anomalies that present as bluish masses. These masses may be focal, with limited skin involvement, or segmental, with more extensive involvement. They may be associated with syndromic conditions such as blue rubber nevus syndrome.\n\nSVMs are characterised by a progressive worsening course, with repeated episodes of superficial venous thrombosis occurring. These episodes become more frequent over time, causing acute, intense and often highly debilitating pain.\n\nTo limit progression and in cases of functional impairment, long-term treatments may be offered. These include venous compression, targeted therapies such as mTOR inhibitors, and, where possible, surgical treatment or sclerotherapy.\n\nHowever, the management of intra-SVM superficial venous thrombosis is not currently standardised, especially in the pediatric population. This study aims to evaluate the benefits of Acetylsalicylic acid (ASA) as an add-on treatment to local non-steroidal anti-inflammatory drug for the management of thrombotic episodes in superficial venous malformations in children aged 6 to 17 years.",[146,147],"Venous Malformation, Low Flow","Venous Malformations",[149,150,151],"superficial venous thrombosis","superficial venous malformations","acetylsalicylic acid","NOT_YET_RECRUITING","2026-06-16",{"date":155,"type":156},"2026-06-23","ACTUAL",{"date":158,"type":140},"2026-09",{"date":160,"type":140},"2030-10-31",{"name":5,"class":6},6]