NCT04924322 · Yale University
Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies
(CRETE)
What this study is about
The goal of the CRETE Studies is to investigate the newly identified age-dependent heterogeneity in the effectiveness of enoxaparin in reducing the risk of central venous catheter-associated deep venous thrombosis in critically ill children.
View original scientific description
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.
Interventions
DRUG
Enoxaparin
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.
Primary outcome measures
Number of children with CADVT
Time frame: Up to removal of CVC (maximum of 28 days)
Thrombus in the central vein where the CVC was inserted that is diagnosed with systematic ultrasonographic surveillance.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- \>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
- 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 confi
Where
- Birmingham, Alabama
- Little Rock, Arkansas
- Aurora, Colorado
- New Haven, Connecticut
- Gainesville, Florida
- St. Petersburg, Florida
- Peoria, Illinois
- Iowa City, Iowa
- St Louis, Missouri
- New York, New York
- Rochester, New York
- Valhalla, New York
And 9 more locations — see the full list below.
Collaborators
Children's Hospital Colorado, Children's Hospital of Philadelphia, BJC HealthCare, Medical College of Wisconsin, Children's of Alabama, Golisano Children's Hospital, Maria Fareri Children's Hospital, Nationwide Children's Hospital, New York Presbyterian Hospital, Penn State University, University of Iowa, Johns Hopkins All Children's Hospital, University of Oklahoma, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Children's Hospital of Illinois at Peoria, Hassenfeld Children's Hospital
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 8, 2026 · Source of record for eligibility and locations