ENOXAPARIN SODIUM for Venous malformation (low-flow venous/lymphatic malformation)

Inclusion criteria

• {"criterion_text":"- 1. Patients aged 0–18 years with a diagnosis of venous or low-flow venous/lymphatic malformation.\n- 2. Scheduled percutaneous invasive procedure during the study period: sclerotherapy, cryoablation, or electroporation.\n- 3. Signed informed consent from the patient, parents, or legal guardians (and assent for patients ≥12 years)."}

Exclusion criteria

• {"criterion_text":"- 1. Patients on active anticoagulant treatment.\n- 10. Glomerular filtration rate < 30 ml/m²/min calculated using the Schwartz formula.\n- 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\n- 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\n- 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\n- 14. Uncontrolled arterial hypertension.\n- 15. Pregnancy or breastfeeding.\n- 16. Psychological or cognitive disorders that prevent treatment administration or inability to attend scheduled study visits.\n- 17. Simultaneous participation in another clinical trial with medication.\n- 2. Known allergy or hypersensitivity to enoxaparin.\n- 3. History of heparin-induced thrombocytopenia.\n- 4. Presence of severe unrelated disease that prevents the procedure or administration of enoxaparin.\n- 5. Thrombocytopenia < 50,000/mm³.\n- 6. Active or recent bleeding (severe gastrointestinal bleeding with hemodynamic compromise or urgent need for intervention, or cerebral hemorrhage in the last 3 months).\n- 7. Spinal or epidural anesthesia or locoregional anesthesia within 24 hours prior to study treatment.\n- 8. Major surgery or severe trauma in the last 4 weeks.\n- 9. Scheduled lumbar puncture during the study."}

Primary endpoints

• {"endpoint_text":"- 1. Values of localized intravascular coagulopathy and endothelial damage in patients receiving/not receiving prophylactic treatment with enoxaparin.","definition_or_measurement_approach":"Assessment of values of localized intravascular coagulopathy and endothelial damage in treated vs untreated patients (see secondary endpoints for specific biomarkers measured)."}
• {"endpoint_text":"- 2. Hemorrhagic clinical signs related to treatment through: • Subjective assessment of bleeding • Hemoglobin levels • Classification of haemorrhage","definition_or_measurement_approach":"Measured by subjective assessment of bleeding, hemoglobin level measurements, and haemorrhage classification."}

Secondary endpoints

• {"endpoint_text":"- 1. Baseline analytical parameters of localized intravascular coagulopathy and endothelial damage.","definition_or_measurement_approach":"Baseline laboratory/analytical parameters for localized intravascular coagulopathy and endothelial damage (specific assays not detailed here)."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measurement of D-dimer, fibrinogen, platelets and correlation with clinical risk factors (age, malformation extent/characteristics, genetic diagnosis, tissue involvement)."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Analytical parameter measurements correlated with clinical outcomes: inflammation degree, post-intervention pain, new phleboliths, and occurrence of deep vein thrombosis."}

Spain

Earliest CTIS Part Ii Submission Date

20-06-2025

Latest Decision Or Authorization Date

22-07-2025

Processing Time Days

32

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

Fundacio Sant Joan De Deu

Organisation Type

Patient organisation/association

Country Of Registered Address

Spain

Third parties

• {"country":"","full_name":"Instituto de Salud Carlos III (ISCIII)","duties_or_roles":"Monetary support","organisation_type":""}