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.

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Препарат 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.
• Препарат Application of Diclofenac gel 1% twice a day
  Application of 1% diclofenac gel (NSAID) twice a day.

Первичные конечные точки

• The primary criterion is the total pain experienced during the episode, reflecting both intensity and duration. [Срок оценки: 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.]

Вторичные конечные точки (12)

• Total consumption of analgesics [Срок оценки: Over the 14-day period after the start of treatment]
• Child's quality of life [Срок оценки: At baseline and 2 weeks after the start of the treatment;]
• Child's quality of life [Срок оценки: At baseline and 2 weeks after the start of the treatment;]
• Sleep quality [Срок оценки: Measured once a day for 14 days]
• Functional impairment [Срок оценки: Daily over 14 days, at baseline and 2 weeks after the start of the treatment;]
• Coagulation markers: Hemoglobin [Срок оценки: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment]
• Coagulation markers: Platelets [Срок оценки: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment]
• Coagulation markers: Prothrombin time [Срок оценки: 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 [Срок оценки: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment]
• Coagulation markers: Fibrinogen [Срок оценки: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment]
• Coagulation markers: D-dimer [Срок оценки: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment]
• Coagulation markers: Factor V [Срок оценки: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Франция · 6 центров

• 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

Идентификаторы

NCT: NCT07663825 · DR200086 · 2024-517595-38-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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