StudyFinder
Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies
RECRUITING
Up to 17 years old
Inclusion criteria
• \>36 weeks corrected gestational to \<17 years old
• \<24 hours after insertion of an untunneled CVC
• CVC inserted in the internal jugular or femoral vein Exclusion criteria
• Radiologic diagnosis of CADVT in the site of insertion in prior 6 weeks
• Currently receiving an antithrombotic agent, e.g., LMWH, UFH, warfarin and aspirin, but not UFH at dose to maintain patency of a vascular catheter
• Presence of clinically relevant bleeding, i.e., hemoglobin decreased ≥2 g/dl in 24 hours, required medical or surgical intervention to restore hemostasis, or in the retroperitoneum, pulmonary, intracranial or central nervous system, in the prior 60 days
• Surgery in the prior 7 days
• Major trauma in the prior 7 days
• Presence of coagulopathy, i.e., INR \>2.0, aPTT \>50 seconds or platelet count \<50 x 10\^3/mcL
• Presence of renal failure, i.e., creatinine clearance \<30 mL/min/1.73 m2
• Known hypersensitivity to heparin or pork products
• Laboratory confirmed HIT
• Current pregnancy or lactation
• Presence of an epidural catheter
• Limitation of care
• Previous enrollment in the CRETE Studies
• \>36 weeks corrected gestational to \<17 years old
• \<24 hours after insertion of an untunneled CVC
• CVC inserted in the internal jugular or femoral vein Exclusion criteria
• Radiologic diagnosis of CADVT in the site of insertion in prior 6 weeks
• Currently receiving an antithrombotic agent, e.g., LMWH, UFH, warfarin and aspirin, but not UFH at dose to maintain patency of a vascular catheter
• Presence of clinically relevant bleeding, i.e., hemoglobin decreased ≥2 g/dl in 24 hours, required medical or surgical intervention to restore hemostasis, or in the retroperitoneum, pulmonary, intracranial or central nervous system, in the prior 60 days
• Surgery in the prior 7 days
• Major trauma in the prior 7 days
• Presence of coagulopathy, i.e., INR \>2.0, aPTT \>50 seconds or platelet count \<50 x 10\^3/mcL
• Presence of renal failure, i.e., creatinine clearance \<30 mL/min/1.73 m2
• Known hypersensitivity to heparin or pork products
• Laboratory confirmed HIT
• Current pregnancy or lactation
• Presence of an epidural catheter
• Limitation of care
• Previous enrollment in the CRETE Studies
DRUG: Enoxaparin
Deep Venous Thrombosis
child, critical illness, venous thromboembolism, enoxaparin, thrombin generation, bleed
E. Vincent Faustino, MD, MHS - vince.faustino@yale.edu
NCT04924322