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.

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-17
SponsorUniversity Hospital, Tours

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

Patients with deep or syndromic venous malformation

Patients with known G6PD deficiency

Patients with known mastocytosis

History of hemarthrosis

Trial design

Treatments tested in this trial

  • AAS at anti-inflammatory doses from 3 days to 14 days.
  • Placebo from 3 days to 14 days.
  • Application of Diclofenac gel 1% twice a day

Treatment groups

34 Participants
are divided into 2 treatment groups

Sponsors and collaborators