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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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.
- Who it may be relevant to
- Registry conditions: Venous Malformation, Low Flow, Venous Malformations. Basic parameters: 6 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
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.
Interventions
- 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. - Drug 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. - Drug Application of Diclofenac gel 1% twice a day
Application of 1% diclofenac gel (NSAID) twice a day.
Primary outcome measures
- The primary criterion is the total pain experienced during the episode, reflecting both intensity and duration. [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 outcome measures (12)
- Total consumption of analgesics [Time frame: Over the 14-day period after the start of treatment]
- Child's quality of life [Time frame: At baseline and 2 weeks after the start of the treatment;]
- Child's quality of life [Time frame: At baseline and 2 weeks after the start of the treatment;]
- Sleep quality [Time frame: Measured once a day for 14 days]
- Functional impairment [Time frame: Daily over 14 days, at baseline and 2 weeks after the start of the treatment;]
- Coagulation markers: Hemoglobin [Time frame: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment]
- Coagulation markers: Platelets [Time frame: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment]
- Coagulation markers: Prothrombin time [Time frame: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment]
- Coagulation markers: Activated partial thromboplastin time [Time frame: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment]
- Coagulation markers: Fibrinogen [Time frame: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment]
- Coagulation markers: D-dimer [Time frame: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment]
- Coagulation markers: Factor V [Time frame: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
France · 6 centers
- Centre Hospitalier Universitaire d'Angers — Angers
- Centre Hospitalier Universitaire de Brest — Brest
- AP-HM — Marseille
- Centre Hospitalier Universitaire de Nantes — Nantes
- AP-HP — Paris
- Centre Hospitalier Universitaire de Rennes — Rennes
Identifiers
NCT: NCT07663825 · DR200086 · 2024-517595-38-00