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)
2026年6月16日 更新者：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.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
34
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Sophie LEDUCQ, MD, PhD
- 電話番号：+332 47 47 56 02
- メール：S.LEDUCQ@chu-tours.fr
研究連絡先のバックアップ
- 名前：Coralie TAILLEBUIS
- メール：cpcq@chu-tours.fr
研究場所
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Angers、フランス
- Centre Hospitalier Universitaire d'Angers
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コンタクト：
- Ludovic MARTIN
- 電話番号：+332 41 35 34 19
- メール：lumartin@chu-angers.fr
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Brest、フランス
- Centre Hospitalier Universitaire de Brest
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コンタクト：
- Claire ABASQ-THOMAS
- 電話番号：+332 98 22 33 15
- メール：claire.abasq@chu-brest.fr
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Marseille、フランス
- AP-HM
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コンタクト：
- Stéphanie MALLET
- 電話番号：+334 91 38 88 01
- メール：Stephanie.MALLET@ap-hm.fr
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Nantes、フランス
- Centre Hospitalier Universitaire de Nantes
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コンタクト：
- Sébastien BARBAROT, MD
- 電話番号：+332 40 08 40 86
- メール：sebastien.barbarot@chu-nantes.fr
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Paris、フランス
- AP-HP
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コンタクト：
- Olivia BOCCARA
- 電話番号：+331 44 49 46 63
- メール：olivia.boccara@aphp.fr
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Rennes、フランス
- Centre Hospitalier Universitaire de Rennes
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コンタクト：
- Catherine DROITCOURT
- 電話番号：+332 99 28 98 89
- メール：catherine.droitcourt@chu-rennes.fr
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：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).
|
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 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 1% diclofenac gel (NSAID) twice a day.
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他の：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).
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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 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 1% diclofenac gel (NSAID) twice a day.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The primary criterion is the total pain experienced during the episode, reflecting both intensity and duration.
時間枠：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.
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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.
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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.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Total consumption of analgesics
時間枠：Over the 14-day period after the start of treatment
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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)
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Over the 14-day period after the start of treatment
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Child's quality of life
時間枠：At baseline and 2 weeks after the start of the treatment;
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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.
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At baseline and 2 weeks after the start of the treatment;
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Child's quality of life
時間枠：At baseline and 2 weeks after the start of the treatment;
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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.
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At baseline and 2 weeks after the start of the treatment;
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Sleep quality
時間枠：Measured once a day for 14 days
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Fast Score SLEEP VASC a scale scoring from 0 to 10, 10 being the best sleep quality
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Measured once a day for 14 days
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Functional impairment
時間枠：Daily over 14 days, at baseline and 2 weeks after the start of the treatment;
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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)
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Daily over 14 days, at baseline and 2 weeks after the start of the treatment;
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Coagulation markers: Hemoglobin
時間枠：At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
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Hemoglobin
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At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
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Coagulation markers: Platelets
時間枠：At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
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Platelets
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At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
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Coagulation markers: Prothrombin time
時間枠：At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
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Prothrombin time
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At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
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Coagulation markers: Activated partial thromboplastin time
時間枠：At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
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Activated partial thromboplastin time
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At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
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Coagulation markers: Fibrinogen
時間枠：At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
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Fibrinogen
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At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
|
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Coagulation markers: D-dimer
時間枠：At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
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D-dimer
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At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
|
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Coagulation markers: Factor V
時間枠：At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
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Factor V
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At baseline, within 72 hours after the start of the treatment, and 2 weeks after the start of the treatment
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Tolerability: Serious and non-serious adverse events
時間枠：Through study completion, an average of 2 years
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Number of serious and non-serious adverse events
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Through study completion, an average of 2 years
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2030年9月1日
研究の完了 (推定)
2030年10月31日
試験登録日
最初に提出
2026年5月26日
QC基準を満たした最初の提出物
2026年6月16日
最初の投稿 (実際)
2026年6月23日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月23日
QC基準を満たした最後の更新が送信されました
2026年6月16日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- DR200086
- 2024-517595-38-00 (Ctis)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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いいえ
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いいえ
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