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)
2026년 6월 16일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
정황
연구 유형
중재적
등록 (추정된)
34
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Sophie LEDUCQ, MD, PhD
- 전화번호: +332 47 47 56 02
- 이메일: S.LEDUCQ@chu-tours.fr
연구 연락처 백업
- 이름: Coralie TAILLEBUIS
- 이메일: cpcq@chu-tours.fr
연구 장소
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Angers, 프랑스
- Centre Hospitalier Universitaire d'Angers
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연락하다:
- Ludovic MARTIN
- 전화번호: +332 41 35 34 19
- 이메일: lumartin@chu-angers.fr
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Brest, 프랑스
- Centre Hospitalier Universitaire de Brest
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연락하다:
- Claire ABASQ-THOMAS
- 전화번호: +332 98 22 33 15
- 이메일: claire.abasq@chu-brest.fr
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Marseille, 프랑스
- AP-HM
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연락하다:
- Stéphanie MALLET
- 전화번호: +334 91 38 88 01
- 이메일: Stephanie.MALLET@ap-hm.fr
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Nantes, 프랑스
- Centre Hospitalier Universitaire de Nantes
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연락하다:
- Sébastien BARBAROT, MD
- 전화번호: +332 40 08 40 86
- 이메일: sebastien.barbarot@chu-nantes.fr
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Paris, 프랑스
- AP-HP
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연락하다:
- Olivia BOCCARA
- 전화번호: +331 44 49 46 63
- 이메일: olivia.boccara@aphp.fr
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Rennes, 프랑스
- Centre Hospitalier Universitaire de Rennes
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연락하다:
- Catherine DROITCOURT
- 전화번호: +332 99 28 98 89
- 이메일: catherine.droitcourt@chu-rennes.fr
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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다른: 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).
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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.
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다른: 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).
|
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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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The primary criterion is the total pain experienced during the episode, reflecting both intensity and duration.
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total consumption of analgesics
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Tolerability: Serious and non-serious adverse events
기간: 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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연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2030년 9월 1일
연구 완료 (추정된)
2030년 10월 31일
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2026년 6월 16일
처음 게시됨 (실제)
2026년 6월 23일
연구 기록 업데이트
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기타 연구 ID 번호
- DR200086
- 2024-517595-38-00 (씨티스)
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