Catheter-Related Early Thromboprophylaxis With Enoxaparin (CRETE) Trial
Condition: Deep Venous Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Intervention: Enoxaparin
Intervention description: The clinical nurse will give enoxaparin subcutaneously every 12 hours at the currently used starting dose of 0.75 mg/kg for children ≤2 months old or 0.5 mg/kg (maximum of 40 mg) for older children. The 1st dose will be given <24 hours after insertion of the catheter. Doses will be adjusted to target an anti-Xa level of 0.2-0.5 IU/mL.
Intervention MeSH terms: Enoxaparin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Eligible subjects will be randomized 1:1 to treatment or control.
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No
Keywords: child; critical illness; venous thromboembolism; enoxaparin; thrombin generation

Summary:

      The purpose of this phase 2a, multi-center, randomized controlled study, is to explore the
      efficacy of early prophylaxis against catheter-associated deep venous thrombosis (CADVT) in
      critically ill children.
    

Eligibility criteria:

        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