Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07663825

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.

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Venous Malformation, Low Flow Venous Malformations

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier Universitaire d'Angers, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AAS at anti-inflammatory doses from 3 days to 14 days.

Drug

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.

Placebo from 3 days to 14 days.

Drug

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.

Application of Diclofenac gel 1% twice a day

Drug

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

Primary outcomes

  1. 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.

    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.

Secondary outcomes

  1. Total consumption of analgesics

    Time frame: 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)

  2. Child's quality of life

    Time frame: 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.

  3. Child's quality of life

    Time frame: 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.

  4. Sleep quality

    Time frame: Measured once a day for 14 days

    Fast Score SLEEP VASC a scale scoring from 0 to 10, 10 being the best sleep quality

  5. Functional impairment

    Time frame: 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)

  6. 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

    Hemoglobin

  7. 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

    Platelets

  8. 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

    Prothrombin time

  9. 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

    Activated partial thromboplastin time

  10. 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

    Fibrinogen

  11. 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

    D-dimer

  12. 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

    Factor V

Other outcomes

  1. Tolerability: Serious and non-serious adverse events

    Time frame: Through study completion, an average of 2 years

    Number of serious and non-serious adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Coralie TAILLEBUIS

CONTACT

[email protected]

Sophie LEDUCQ, MD, PhD

CONTACT

[email protected]

+332 47 47 56 02

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study 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

Acronym: ASPIRIN

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jun 23, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.