Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

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. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

34

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Francie
      • Angers, Francie
        • Centre Hospitalier Universitaire d'Angers
        • Kontakt:
      • Brest, Francie
        • Centre Hospitalier Universitaire de Brest
        • Kontakt:
      • Marseille, Francie
      • Nantes, Francie
      • Paris, Francie
      • Rennes, Francie

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Crossover Assignment
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Jiný: 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).
Lék: 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.
Lék: 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.
Lék: Application of Diclofenac gel 1% twice a day
Application of 1% diclofenac gel (NSAID) twice a day.
Jiný: 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).
Lék: 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.
Lék: 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.
Lék: Application of Diclofenac gel 1% twice a day
Application of 1% diclofenac gel (NSAID) twice a day.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
The primary criterion is the total pain experienced during the episode, reflecting both intensity and duration.
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Total consumption of analgesics
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Tolerability: Serious and non-serious adverse events
Časové okno: Through study completion, an average of 2 years
Number of serious and non-serious adverse events
Through study completion, an average of 2 years

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University Hospital, Tours

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. září 2026

Primární dokončení (Odhadovaný)

1. září 2030

Dokončení studie (Odhadovaný)

31. října 2030

Termíny zápisu do studia

První předloženo

26. května 2026

První předloženo, které splnilo kritéria kontroly kvality

16. června 2026

První zveřejněno (Aktuální)

23. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

23. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

16. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

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

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Předplatit