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Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies
RecruitingPhase 2/3
Age-dependent Heterogeneity in the Efficacy of Prophylaxis With Enoxaparin Against Catheter-associated Thrombosis in Critically Ill Children
Who can join
Up to age 17 · All sexes
Full eligibility criteria
Inclusion criteria 1. \>36 weeks corrected gestational to \<17 years old 2. \<24 hours after insertion of an untunneled CVC 3. CVC inserted in the internal jugular or femoral vein Exclusion criteria 1. Radiologic diagnosis of CADVT in the site of insertion in prior 6 weeks 2. Currently receiving an antithrombotic agent, e.g., LMWH, UFH, warfarin and aspirin, but not UFH at dose to maintain patency of a vascular catheter 3. 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 4. Surgery in the prior 7 days 5. Major trauma in the prior 7 days 6. Presence of coagulopathy, i.e., INR \>2.0, aPTT \>50 seconds or platelet count \<50 x 10\^3/mcL 7. Presence of renal failure, i.e., creatinine clearance \<30 mL/min/1.73 m2 8. Known hypersensitivity to heparin or pork products 9. Laboratory confirmed HIT 10. Current pregnancy or lactation 11. Presence of an epidural catheter 12. Limitation of care 13. Previous enrollment in the CRETE Studies
About the study
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.
What is being tested
- Enoxaparin (drug)
Sponsor: Yale University · Participants: 258 · Started: May 11, 2022
Contact the study team
- E. Vincent Faustino, MD, MHS · Phone: 203-785-4651
- Tara McPartland, MSW, MPH · Phone: 203-737-7173
Official record on ClinicalTrials.gov — NCT04924322
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.