2024-517595-38-00招募中3 期
ASPIRIN - Acetylsalicylic acid versus placebo in addition to a local non-steroidal anti-inflammatory drug in the treatment of thrombotic episodes in superficial venous malformations in children aged 6 to 17 years: a controlled randomised, double-blind, cross-over, multicenter trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 7
- 主要终点
- Evaluation of the efficacy on pain of acetylsalicylic acid + local NSAID versus placebo + local NSAID, administered for a period of 3 days to 14 days
研究概览
简要总结
To evaluate the efficacy of per os acetylsalicylic acid versus placebo, in addition to a local non-steroidal anti-inflammatory drug, on the pain associated with superficial venous thrombosis in children with superficial venous malformations
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-up assessments and visit
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Patients aged 6 to 17 included
- •Weight ≥ 20 kg
- •Isolated or combined superficial venous malformation, whatever the topography, confirmed by imaging (MRI, CT, Doppler ultrasound), 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
排除标准
- •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
- •Patients with galactose intolerance, Lapp lactase deficiency or glucose or galactose malabsorption syndrome
- •Known allergy to NSAIDs
- •Patient with Klippel-Trenaunay syndrome or Cloves syndrome
- •History of peptic ulcer disease or chronic gastritis
- •History of asthma, angioedema, urticaria, or acute rhinitis triggered by diclofenac, acetylsalicylic acid, or other nonsteroidal anti-inflammatory drugs
- •Allergy to one of the excipients of diclofenac gel
- •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
结局指标
主要结局
Evaluation of the efficacy on pain of acetylsalicylic acid + local NSAID versus placebo + local NSAID, administered for a period of 3 days to 14 days
Evaluation of the efficacy on pain of acetylsalicylic acid + local NSAID versus placebo + local NSAID, administered for a period of 3 days to 14 days
次要结局
- Cumulative consumption of tier 1 and 2 analgesics (indirect reflection of treatment efficacy) over 14 days
- Impact on the child's quality of life (by measuring the C-DLQI - Children-Quality of Life Index and the CLFMQol - specific Quality Of Life measurement tool for Children with Low-Flow Malformations) at baseline, and after each attack
- Safety: number of serious and non-serious adverse events in each group
- Comparison of the impact of experimental treatment and control treatment on coagulation markers during attacks of superficial venous thrombosis in superficial venous malformations, by measuring : CBC, PT, APTT, plasma fibrinogen and D-dimers
- Impact of the malformation on sleep quality (Fast Score SLEEP VASC) measured once a day for 14 days
- Functional impairment related to the malformation will be assessed daily using a VAS (visual analog scale, ranging from 0 to 10) (0 no discomfort, 10 maximum discomfort, inability to move a limb or body segment) at baseline and after each follow-up.
研究者
Sophie LEDUCQ
Scientific
Centre Hospitalier Regional Universitaire De Tours
研究点 (7)
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