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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 junio de 2026 actualizado 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

34

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Sophie LEDUCQ, MD, PhD
  • Número de teléfono: +332 47 47 56 02
  • Correo electrónico: S.LEDUCQ@chu-tours.fr

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Francia
      • Angers, Francia
        • Centre Hospitalier Universitaire d'Angers
        • Contacto:
      • Brest, Francia
        • Centre Hospitalier Universitaire de Brest
        • Contacto:
      • Marseille, Francia
      • Nantes, Francia
        • Centre Hospitalier Universitaire de Nantes
        • Contacto:
      • Paris, Francia
        • AP-HP
        • Contacto:
      • Rennes, Francia
        • Centre Hospitalier Universitaire de Rennes
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Otro: 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).
Droga: 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.
Droga: 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.
Droga: Application of Diclofenac gel 1% twice a day
Application of 1% diclofenac gel (NSAID) twice a day.
Otro: 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).
Droga: 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.
Droga: 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.
Droga: Application of Diclofenac gel 1% twice a day
Application of 1% diclofenac gel (NSAID) twice a day.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The primary criterion is the total pain experienced during the episode, reflecting both intensity and duration.
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Total consumption of analgesics
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Tolerability: Serious and non-serious adverse events
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University Hospital, Tours

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de septiembre de 2030

Finalización del estudio (Estimado)

31 de octubre de 2030

Fechas de registro del estudio

Enviado por primera vez

26 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

16 de junio de 2026

Publicado por primera vez (Actual)

23 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

16 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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