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.
SVMs 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.
To 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.
However, 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.
Patients aged 6 to 17 years
Weight ≥ 20 kg
Isolated or combined superficial venous malformation, confirmed by imaging, with the presence of phleboliths indicating the occurrence of previous superficial venous thrombosis
Complicated by acute thrombotic episodes (2 or more in the previous 12 months)
Patients with deep or syndromic venous malformation
Patients with known G6PD deficiency
Patients with known mastocytosis
History of hemarthrosis
Crossover
AAS at anti-inflammatory doses from 3 days to 14 days.
DrugAAS 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.
Placebo from 3 days to 14 days.
DrugPlacebo 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.
Application of Diclofenac gel 1% twice a day
DrugApplication of 1% diclofenac gel (NSAID) twice a day.
The primary criterion is the total pain experienced during the episode, reflecting both intensity and duration.
Pain intensity will be measured using a visual analog scale (VAS) ranging from 0 (no pain) to 10 (the most intense pain imaginable). The child will self-assess their pain, with a parent's help if necessary, twice a day (morning and evening). The area under the EVA-time curve is calculated using the trapezoidal method based on the available values over the duration of the episode.
Total consumption of analgesics
Total consumption of analgesics over the 14-day period. Each day, parents will record in a patient logbook, in addition to the pain VAS score, all medication doses (study medications and others)
Child's quality of life
Child's quality of life as measured by the C-DLQI \[Children's Dematology Quality of Life Index\] scoring from 0 to 30, 0-1 = no effect on child's life · 2-6 = small effect · 7-12 = moderate effect · 13-18 = very large effect · 19-30 = extremely large effect.
Child's quality of life
Child's quality of life measured by the CLFMQol \[Specific Quality of Life Questionnaire for Slow-Flow Vascular Malformations\] including 15 items, with a total score ranging from 0 to 45, 0 being the worst value and 45 the best value.
Sleep quality
Fast Score SLEEP VASC a scale scoring from 0 to 10, 10 being the best sleep quality
Tolerability: Serious and non-serious adverse events
Number of serious and non-serious adverse events
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