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.

Phase 2Not Yet RecruitingNCT07663825

University Hospital, Tours34 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Venous Malformation, Low Flow Venous Malformations

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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) * Written consent of the child's legal representatives or of the participant if over 18 years of age * Affiliation of a social security scheme * Highly effective contraception for young women of childbearing age Exclusion Criteria: * Patients with deep or syndromic venous malformation * Patients with known G6PD deficiency * Patients with known mastocytosis * History of hemarthrosis * Simultaneous participation in another biomedical study * Constitutional or acquired haemostasis pathology * Current treatment affecting haemostasis (anticoagulants, platelet anti aggregants, oral NSAIDs) * Frequent bleeding (epistaxis, other) requiring management * Basic treatment of venous malformation (mTOR inhibitor) * Active neoplasia or infection (altered coagulation balance) * Known allergy to acetylsalicylic acid * Injured skin, whatever the lesion: oozing dermatitis, eczema, infected lesions, burns or wounds * Pregnant and breastfeeding women * Severe renal insufficiency, severe hepatic insufficiency, severe uncontrolled cardiac insufficiency * Methotrexate ≥ 20 mg/week

Outcomes

Primary Outcomes

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.

Time frame: The first measurement is defined as the start of treatment following the onset of pain reported by the child. VAS data will be collected until the child has a VAS of 0 for two consecutive days, or for up to 14 days.

Secondary Outcomes

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)

Time frame: Over the 14-day period after the start of treatment

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.

Time frame: At baseline and 2 weeks after the start of the treatment;

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.

Time frame: At baseline and 2 weeks after the start of the treatment;

Sleep quality

Fast Score SLEEP VASC a scale scoring from 0 to 10, 10 being the best sleep quality

Time frame: Measured once a day for 14 days

Functional impairment

Functional impairment related to the malformation will be assessed using a VAS ranging from 0 to 10 (0 = no discomfort, 10 = maximum discomfort; inability to move a limb or body segment)

Time frame: Daily over 14 days, at baseline and 2 weeks after the start of the treatment;

Coagulation markers: Hemoglobin

Hemoglobin