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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. (ASPIRIN)

16 de junho de 2026 atualizado por: University Hospital, Tours

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

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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

34

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • França
      • Angers, França
        • Centre Hospitalier Universitaire d'Angers
        • Contato:
      • Brest, França
        • Centre Hospitalier Universitaire de Brest
        • Contato:
      • Marseille, França
      • Nantes, França
      • Paris, França
      • Rennes, França

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Outro: ASA + local NSAID then placebo + local NSAIDs
This is a cross-over design. Patients randomized in this sequence will receive ASA + local NSAIDs during their first flare-up, then placebo + local NSAIDs during their second flare-up (with a wash out period of two weeks).
Medicamento: 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.
Medicamento: 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.
Medicamento: Application of Diclofenac gel 1% twice a day
Application of 1% diclofenac gel (NSAID) twice a day.
Outro: Placebo + local NSAID then AAS + local NSAIDs
This is a cross-over design. Patients randomized in this sequence will receive placebo + local NSAIDs during their first flare-up, then AAS + local NSAIDs during their second flare-up (with a wash out period of two weeks).
Medicamento: 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.
Medicamento: 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.
Medicamento: Application of Diclofenac gel 1% twice a day
Application of 1% diclofenac gel (NSAID) twice a day.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
The primary criterion is the total pain experienced during the episode, reflecting both intensity and duration.
Prazo: 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.
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.
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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Total consumption of analgesics
Prazo: Over the 14-day period after the start of treatment
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)
Over the 14-day period after the start of treatment
Child's quality of life
Prazo: At baseline and 2 weeks after the start of the treatment;
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.
At baseline and 2 weeks after the start of the treatment;
Child's quality of life
Prazo: At baseline and 2 weeks after the start of the treatment;
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.
At baseline and 2 weeks after the start of the treatment;
Sleep quality
Prazo: Measured once a day for 14 days
Fast Score SLEEP VASC a scale scoring from 0 to 10, 10 being the best sleep quality
Measured once a day for 14 days
Functional impairment
Prazo: Daily over 14 days, at baseline and 2 weeks after the start of the treatment;
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)
Daily over 14 days, at baseline and 2 weeks after the start of the treatment;
Coagulation markers: Hemoglobin
Prazo: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
Hemoglobin
At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
Coagulation markers: Platelets
Prazo: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
Platelets
At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
Coagulation markers: Prothrombin time
Prazo: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
Prothrombin time
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
Prazo: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
Activated partial thromboplastin time
At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
Coagulation markers: Fibrinogen
Prazo: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
Fibrinogen
At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
Coagulation markers: D-dimer
Prazo: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
D-dimer
At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
Coagulation markers: Factor V
Prazo: At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
Factor V
At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Tolerability: Serious and non-serious adverse events
Prazo: Through study completion, an average of 2 years
Number of serious and non-serious adverse events
Through study completion, an average of 2 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University Hospital, Tours

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de setembro de 2026

Conclusão Primária (Estimado)

1 de setembro de 2030

Conclusão do estudo (Estimado)

31 de outubro de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

26 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de junho de 2026

Primeira postagem (Real)

23 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

23 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

16 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • DR200086
  • 2024-517595-38-00 (Ctis)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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