
    met protocol defined stopping rule for futility
  
['deep venous thrombosis']
['enoxaparin']

        Inclusion Criteria

          1. Untunneled CVC inserted in the internal jugular or femoral vein within the past 24
             hours

          2. Child anticipated to stay in the pediatric intensive care unit ≥48 hours

          3. CVC anticipated to be required for ≥24 hours

          4. >36 weeks corrected gestational age to <18 years old

        Exclusion Criteria

          1. Coagulopathy (i.e., international normalized ratio >2.0, activated partial
             thromboplastin time >50 seconds or platelet count <50,000/mm3)

          2. Known bleeding disorder

          3. Clinically relevant bleeding as defined by the International Society on Thrombosis and
             Hemostasis (i.e., Hb decreased ≥2 g/dl in 24 hours, required medical or surgical
             intervention to restore hemostasis, or in a critical organ system [i.e.,
             retroperitoneum, pulmonary, intracranial or central nervous system])

          4. <60 days from a clinically relevant bleeding as defined above

          5. <7 days after trauma or surgery

          6. Anticipated surgery within 48 hours after insertion of the CVC

          7. Renal failure (i.e., creatinine clearance <30 mL/min)

          8. Presence of epidural catheter

          9. Currently taking an antithrombotic agent (e.g., low molecular weight heparin (LMWH),
             unfractionated heparin (UFH) at therapeutic doses, Coumadin or aspirin)

         10. Radiologically documented DVT at the site of insertion of the CVC in the previous 6
             weeks

         11. Known hypersensitivity to heparin or its components, including pork products

         12. History of heparin-induced thrombocytopenia (HIT) (i.e., positive serotonin release
             assay)

         13. Currently pregnant

         14. Currently lactating

         15. Prior enrollment in the study

         16. Limitation of care
      