Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies
Age-dependent Heterogeneity in the Efficacy of Prophylaxis With Enoxaparin Against Catheter-associated Thrombosis in Critically Ill Children
Yale University
258 participants
May 11, 2022
INTERVENTIONAL
Conditions
Summary
The goal of the CRETE Studies is to investigate the newly identified age-dependent heterogeneity in the efficacy of enoxaparin in reducing the risk of central venous catheter-associated deep venous thrombosis in critically ill children.
Eligibility
Inclusion Criteria3
- \>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 Criteria13
- 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
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Interventions
Enoxaparin is a LMWH produced from UFH that exerts its anticoagulant effects by binding to and inducing a conformational change in antithrombin to accelerate the inactivation of factor Xa and thrombin. Age-specified dose of enoxaparin will be administered within 24 hours after insertion of the CVC with the dose subsequently adjusted to pre-specified anti-Xa target.
Locations(22)
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NCT04924322