2025-521196-32-00招募中3 期
Phase III, randomized, open-label, single-site clinical trial to evaluate the efficacy and safety of enoxaparin as a prophylactic treatment for localized intravascular coagulopathy and the impact of endothelial damage markers in patients aged 0 to 18 years with slow-flow vascular malformations undergoing percutaneous interventional procedures (PEaRL-X)
Fundacio Sant Joan De Deu1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月22日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 2. Hemorrhagic clinical signs related to treatment through: • Subjective assessment of bleeding • Hemoglobin levels • Classification of haemorrhage
研究概览
简要总结
To evaluate the efficacy and safety of enoxaparin in the prevention of localized intravascular coagulopathy and its complications during percutaneous interventional procedures in pediatric patients with slow-flow vascular malformations.
研究设计
- 分配方式
- Randomized
- 主要目的
- Fase III
- 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 0–18 years with a diagnosis of venous or low-flow venous/lymphatic malformation.
- •Scheduled percutaneous invasive procedure during the study period: sclerotherapy, cryoablation, or electroporation.
- •Signed informed consent from the patient, parents, or legal guardians (and assent for patients ≥12 years).
排除标准
- •Patients on active anticoagulant treatment.
- •Glomerular filtration rate < 30 ml/m²/min calculated using the Schwartz formula.
- •Alanine aminotransferase: • 0 - 1 day of life > 165 U/L • 1 day - 1 month of life > 210 U/L • 1 - 3 months of life > 185 U/L • 3 - 9 months of life > 165 U/L • 9 months - 12 years of life > 155 U/L • 12 - 18 years of life > 150 U/L
- •Aspartate aminotransferase: • 0 - 1 day of life > 475 U/L • 1 day - 1 month of life > 385 U/L • 1 - 2 months of life > 315 U/L • 2 - 9 months of life > 280 U/L • 9 months - 6 years of life > 250 U/L • 6 - 18 years of life > 190 U/L
- •Total bilirubin: • 0 - 1 day of life > 17.91 mg/dL • 1 - 2 days of life > 20.88 mg/dL • 2 - 5 days of life > 17.91 mg/dL • 5 days - 1 year of life > 2.97 mg/dL • 1 - 18 years of life > 2.97 mg/dL
- •Uncontrolled arterial hypertension.
- •Pregnancy or breastfeeding.
- •Psychological or cognitive disorders that prevent treatment administration or inability to attend scheduled study visits.
- •Simultaneous participation in another clinical trial with medication.
- •Known allergy or hypersensitivity to enoxaparin.
- •History of heparin-induced thrombocytopenia.
- •Presence of severe unrelated disease that prevents the procedure or administration of enoxaparin.
- •Thrombocytopenia < 50,000/mm³.
- •Active or recent bleeding (severe gastrointestinal bleeding with hemodynamic compromise or urgent need for intervention, or cerebral hemorrhage in the last 3 months).
- •Spinal or epidural anesthesia or locoregional anesthesia within 24 hours prior to study treatment.
- •Major surgery or severe trauma in the last 4 weeks.
- •Scheduled lumbar puncture during the study.
结局指标
主要结局
2. Hemorrhagic clinical signs related to treatment through: • Subjective assessment of bleeding • Hemoglobin levels • Classification of haemorrhage
2. Hemorrhagic clinical signs related to treatment through: • Subjective assessment of bleeding • Hemoglobin levels • Classification of haemorrhage
1. Values of localized intravascular coagulopathy and endothelial damage in patients receiving/not receiving prophylactic treatment with enoxaparin.
1. Values of localized intravascular coagulopathy and endothelial damage in patients receiving/not receiving prophylactic treatment with enoxaparin.
次要结局
- 1. Baseline analytical parameters of localized intravascular coagulopathy and endothelial damage.
- 2. Values of localized intravascular coagulopathy (D-dimer, fibrinogen, platelets) in relation to possible risk factors: age, characteristics and extent of the malformation, genetic diagnosis, and bone/muscular/visceral involvement.
- 3. Analytical parameters of localized intravascular coagulopathy and endothelial damage in relation to the degree of inflammation, pain presented by patients after the intervention, appearance of new phleboliths, or development of deep vein thrombosis during the study period.
研究者
Dr. Rubén Berrueco
Scientific
Fundacio Sant Joan De Deu
研究点 (1)
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