Venous Malformation, Low Flow, Venous Malformations
Conditions
Keywords
superficial venous thrombosis, superficial venous malformations, acetylsalicylic acid
Brief summary
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.
Interventions
DRUGAAS 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.
DRUGPlacebo 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.
DRUGApplication of Diclofenac gel 1% twice a day
Application of 1% diclofenac gel (NSAID) twice a day.
Sponsors
University Hospital, Tours
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This is a cross-over design with a wash out period of two weeks.
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary criterion is the total pain experienced during the episode, reflecting both intensity and duration. | 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
| Measure | Time frame | Description |
|---|---|---|
| Total consumption of analgesics | 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) |
| Child's quality of life | 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. |
| Sleep quality | Measured once a day for 14 days | Fast Score SLEEP VASC a scale scoring from 0 to 10, 10 being the best sleep quality |
| Functional impairment | 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) |
| Coagulation markers: Hemoglobin | At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment | Hemoglobin |
| Coagulation markers: Platelets | At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment | Platelets |
| Coagulation markers: Prothrombin time | At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment | Prothrombin time |
| Coagulation markers: Activated partial thromboplastin time | At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment | Activated partial thromboplastin time |
| Coagulation markers: Fibrinogen | At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment | Fibrinogen |
| Coagulation markers: D-dimer | At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment | D-dimer |
| Coagulation markers: Factor V | At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment | Factor V |
Countries
France
Contacts
CONTACTSophie LEDUCQ, MD, PhD
CONTACTCoralie TAILLEBUIS
Outcome results
None listed