Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies

Recruiting now · Phase 2/Phase 3

Conditions studied: Deep Venous Thrombosis

In brief

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.

Key facts

Study ID

NCT04924322

Run by

Yale University

People needed

258

Starts

2022-05-11

Expected to finish

2027-08-31

Last updated by the study team

2026-06-08

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >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

You may not qualify if…

• 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

Where it is running

• Children's Hospital Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
• Arkansas Children's Hospital — Little Rock, Arkansas, United States (enrolling)
• Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
• Yale-New Haven Children's Hospital — New Haven, Connecticut, United States (enrolling)
• University of Florida -UF Health — Gainesville, Florida, United States (enrolling)
• Johns Hopkins All Children's — St. Petersburg, Florida, United States (enrolling)
• Children's Hospital of Illinois at OSF Saint Francis Medical Center — Peoria, Illinois, United States (enrolling)
• Stead Family Children's Hospital — Iowa City, Iowa, United States (enrolling)
• Children's Hospital St. Louis — St Louis, Missouri, United States (enrolling)
• Hassenfeld Children's Hospital — New York, New York, United States (enrolling)
• New York Presbyterian Hospital — New York, New York, United States (enrolling)
• Golisano Children's Hospital — Rochester, New York, United States (enrolling)
• Maria Fareri Children's Hospital — Valhalla, New York, United States (enrolling)
• UH Rainbow Babies & Children's Hospital — Cleveland, Ohio, United States (enrolling)
• UTSW Medical Center; Children's Medical Center of Dallas — Dallas, Texas, United States (enrolling)
• Children's of Alabama — Birmingham, Alabama, United States (enrolling)
• University of Oklahoma — Oklahoma City, Oklahoma, United States (enrolling)
• Penn State Hershey Children's Hospital — Hershey, Pennsylvania, United States (enrolling)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
• Dell Children's Medical Canter — Austin, Texas, United States (enrolling)
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Children's Hospital of Richmond — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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