ACETYLSALICYLIC ACID for Superficial venous malformation | Superficial venous thrombosis

Stratification factors

• center

Inclusion criteria

• {"criterion_text":"- Patients aged 6 to 17 included"}
• {"criterion_text":"- Weight ≥ 20 kg"}
• {"criterion_text":"- Isolated or combined superficial venous malformation, whatever the topography, confirmed by imaging (MRI, CT, Doppler ultrasound), with the presence of phleboliths indicating the occurrence of previous superficial venous thrombosis"}
• {"criterion_text":"- Complicated by acute thrombotic episodes (2 or more in the previous 12 months)"}
• {"criterion_text":"- Written consent of the child's legal representatives or of the participant if over 18 years of age"}
• {"criterion_text":"- Affiliation of a social security scheme"}
• {"criterion_text":"- Highly effective contraception for young women of childbearing age"}

Exclusion criteria

• {"criterion_text":"- Patients with deep or syndromic venous malformation"}
• {"criterion_text":"- Patients with known G6PD deficiency"}
• {"criterion_text":"- Patients with known mastocytosis"}
• {"criterion_text":"- History of hemarthrosis"}
• {"criterion_text":"- Simultaneous participation in another biomedical study"}
• {"criterion_text":"- Constitutional or acquired haemostasis pathology"}
• {"criterion_text":"- Current treatment affecting haemostasis (anticoagulants, platelet anti-aggregants, oral NSAIDs)"}
• {"criterion_text":"- Frequent bleeding (epistaxis, other) requiring management"}
• {"criterion_text":"- Basic treatment of venous malformation (mTOR inhibitor)"}
• {"criterion_text":"- Active neoplasia or infection (altered coagulation balance)"}
• {"criterion_text":"- Known allergy to acetylsalicylic acid"}
• {"criterion_text":"- Patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome"}
• {"criterion_text":"- Known allergy to NSAIDs"}
• {"criterion_text":"- Patient with Klippel-Trenaunay syndrome or Cloves syndrome"}
• {"criterion_text":"- History of peptic ulcer disease or chronic gastritis"}
• {"criterion_text":"- History of asthma, angioedema, urticaria, or acute rhinitis triggered by diclofenac, acetylsalicylic acid, or other nonsteroidal anti-inflammatory drugs"}
• {"criterion_text":"- Allergy to one of the excipients of diclofenac gel"}
• {"criterion_text":"- Injured skin, whatever the lesion: oozing dermatitis, eczema, infected lesions, burns or wounds"}
• {"criterion_text":"- Pregnant and breastfeeding women"}
• {"criterion_text":"- Severe renal insufficiency, severe hepatic insufficiency, severe uncontrolled cardiac insufficiency"}
• {"criterion_text":"- Methotrexate ≥ 20 mg/week"}

Primary endpoints

• {"endpoint_text":"- Evaluation of the efficacy on pain of acetylsalicylic acid + local NSAID versus placebo + local NSAID, administered for a period of 3 days to 14 days","definition_or_measurement_approach":"Efficacy on pain comparing acetylsalicylic acid + local NSAID versus placebo + local NSAID, treatment administered for 3 to 14 days (no specific pain scale detailed in the endpoint text)"}

Secondary endpoints

• {"endpoint_text":"- Cumulative consumption of tier 1 and 2 analgesics (indirect reflection of treatment efficacy) over 14 days","definition_or_measurement_approach":"Sum of tier 1 and 2 analgesic consumption over 14 days as an indirect measure of efficacy"}
• {"endpoint_text":"- Impact on the child's quality of life (by measuring the C-DLQI - Children-Quality of Life Index and the CLFMQol - specific Quality Of Life measurement tool for Children with Low-Flow Malformations) at baseline, and after each attack","definition_or_measurement_approach":"Quality of life assessed by C-DLQI and CLFMQol at baseline and after each attack"}
• {"endpoint_text":"- Safety: number of serious and non-serious adverse events in each group","definition_or_measurement_approach":"Count and classification of serious and non-serious adverse events per study group"}
• {"endpoint_text":"- Comparison of the impact of experimental treatment and control treatment on coagulation markers during attacks of superficial venous thrombosis in superficial venous malformations, by measuring : CBC, PT, APTT, plasma fibrinogen and D-dimers","definition_or_measurement_approach":"Laboratory measurement of CBC, PT, APTT, plasma fibrinogen and D-dimers to compare coagulation marker changes between arms"}
• {"endpoint_text":"- Impact of the malformation on sleep quality (Fast Score SLEEP VASC) measured once a day for 14 days","definition_or_measurement_approach":"Daily measurement of Fast Score SLEEP VASC once per day for 14 days"}
• {"endpoint_text":"- Functional impairment related to the malformation will be assessed daily using a VAS (visual analog scale, ranging from 0 to 10) (0 no discomfort, 10 maximum discomfort, inability to move a limb or body segment) at baseline and after each follow-up.","definition_or_measurement_approach":"Daily VAS (0-10) for functional impairment at baseline and after each follow-up"}

Methods

• Recruitment during outpatient consultations in dermatology, interventional radiology, surgery, and multidisciplinary consultations dedicated to vascular malformations (France). Verbal information provided and written information given again to patients/parents.
• Monthly contact by the coordinating research nurse at each center to reinforce adherence (follow-up contact, France).

France

Earliest CTIS Part Ii Submission Date

21-01-2026

Latest Decision Or Authorization Date

25-02-2026

Processing Time Days

35

Number Of Sites

7

Number Of Participants

34

Primary sponsor

Full Name

Centre Hospitalier Regional Universitaire De Tours

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France