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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-517595-38-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASA + local NSAID then placebo + local NSAIDs | Other | 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). |
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| Placebo + local NSAID then AAS + local NSAIDs | Other | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary criterion is the total pain experienced during the episode, reflecting both intensity and duration. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total consumption of analgesics | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability: Serious and non-serious adverse events | Number of serious and non-serious adverse events | Through study completion, an average of 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophie LEDUCQ, MD, PhD | Contact | +332 47 47 56 02 | S.LEDUCQ@chu-tours.fr | |
| Coralie TAILLEBUIS | Contact | cpcq@chu-tours.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire d'Angers | Angers | France |
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This is a cross-over design with a wash out period of two weeks.
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| 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. |
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| Application of Diclofenac gel 1% twice a day | Drug | Application of 1% diclofenac gel (NSAID) twice a day. |
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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 | 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 | 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 | 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 | Hemoglobin | At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment |
| Coagulation markers: Platelets | 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 | 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 | 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 | 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 | 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 | Factor V | At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment |
| Centre Hospitalier Universitaire de Brest | Brest | France |
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| AP-HM | Marseille | France |
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| Centre Hospitalier Universitaire de Nantes | Nantes | France |
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| AP-HP | Paris | France |
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| Centre Hospitalier Universitaire de Rennes | Rennes | France |
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