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)
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase III
PATOLOGÍA
Coagulopatías hemorrágicas, Leucemia linfática crónica y otros SLPC, Leucemia linfoblástica aguda, Leucemia mieloide aguda, Linfoma
FECHA DE APERTURA
Julio, 2025
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
1. Patients aged 018 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).
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).
CRITERIOS DE EXCLUSIÓN
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.
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.
DESCRIPCIÓN
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.
PALABRAS CLAVE
acute lymphoblastic leukemia, acute myeloid leukemia, coagulopathy, leucemia linfocítica crónica (llc / cll), ph + acute lymphoblastic leukemia, philadelphia positive acute lymphoblastic leukemia
