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Study to evaluate the efficacy and safety of enoxaparin in children with slow-flow vascular problems undergoing interventional procedures
EU CTIS ID: 2025-521196-32-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Patients aged 0–18 years with a diagnosis of venous or low-flow venous/lymphatic malformation.
- 2. Scheduled percutaneous invasive procedure during the study period: sclerotherapy, cryoablation, or electroporation.
- 3. Signed informed consent from the patient, parents, or legal guardians (and assent for patients ≥12 years).
You likely can't join if
- 1. Patients on active anticoagulant treatment.
- 10. Glomerular filtration rate < 30 ml/m²/min calculated using the Schwartz formula.
- 11. 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
- 12. 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
- 13. 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
- 14. Uncontrolled arterial hypertension.
See the full eligibility criteria
- 1. Patients aged 0–18 years with a diagnosis of venous or low-flow venous/lymphatic malformation.
- 2. Scheduled percutaneous invasive procedure during the study period: sclerotherapy, cryoablation, or electroporation.
- 3. Signed informed consent from the patient, parents, or legal guardians (and assent for patients ≥12 years).
- 1. Patients on active anticoagulant treatment.
- 10. Glomerular filtration rate < 30 ml/m²/min calculated using the Schwartz formula.
- 11. 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
- 12. 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
- 13. 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
- 14. Uncontrolled arterial hypertension.
- 15. Pregnancy or breastfeeding.
- 16. Psychological or cognitive disorders that prevent treatment administration or inability to attend scheduled study visits.
- 17. Simultaneous participation in another clinical trial with medication.
- 2. Known allergy or hypersensitivity to enoxaparin.
- 3. History of heparin-induced thrombocytopenia.
- 4. Presence of severe unrelated disease that prevents the procedure or administration of enoxaparin.
- 5. Thrombocytopenia < 50,000/mm³.
- 6. Active or recent bleeding (severe gastrointestinal bleeding with hemodynamic compromise or urgent need for intervention, or cerebral hemorrhage in the last 3 months).
- 7. Spinal or epidural anesthesia or locoregional anesthesia within 24 hours prior to study treatment.
- 8. Major surgery or severe trauma in the last 4 weeks.
- 9. Scheduled lumbar puncture during the study.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.