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Taking people in United StatesPhase 2/3

Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies

Key facts

Who runs it
Yale University
Where
Aurora, Austin, Birmingham, Cleveland, Columbus, Dallas, Gainesville, Hershey, Iowa City, Little Rock, Milwaukee, New Haven, New York, Oklahoma City, Peoria, Philadelphia, Richmond, Rochester, St Louis, St. Petersburg, and Valhalla, United StatesSee the 22 sites
Trial code
Status
Recruiting
Phase
Phase 2/3
People taking part
258 people, planned
Started
11 May 2022
Expected to end
31 Aug 2027
Type of study
Interventional, 5 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Enoxaparin
Record updated
8 June 2026

Who can take part

Age
Up to 17 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • >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

Who cannot take part

  • 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
  • Surgery in the prior 7 days
  • Major trauma in the prior 7 days
  • Previous enrollment in the CRETE Studies
  • Known hypersensitivity to heparin or pork products
  • 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
  • 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
  • Laboratory confirmed HIT
  • Current pregnancy or lactation
  • Presence of an epidural catheter
  • Limitation of care

Where in United States

  • Children's Hospital ColoradoAurora, United StatesContact: Rachel GreerTaking people
  • Dell Children's Medical CanterAustin, United StatesContact: Michael BoxTaking people
  • Children's of AlabamaBirmingham, United StatesContact: Meghan Murdock, RNTaking people
  • UH Rainbow Babies & Children's HospitalCleveland, United StatesContact: Raj RasalTaking people
  • Nationwide Children's HospitalColumbus, United StatesContact: E. Vincent Faustino, MD, MHSNo longer taking part
  • UTSW Medical Center; Children's Medical Center of DallasDallas, United StatesContact: Teddy Muisyo, MDTaking people
  • University of Florida/UF HealthGainesville, United StatesContact: Melissa LingusTaking people
  • Penn State Hershey Children's HospitalHershey, United StatesContact: Debbie Spear, RNTaking people
  • Stead Family Children's HospitalIowa City, United StatesContact: Maureen Austin, RN, MPH, BSNTaking people
  • Arkansas Children's HospitalLittle Rock, United StatesContact: Masson SpriggsTaking people
  • Children's Hospital WisconsinMilwaukee, United StatesContact: Sadaf Shad, MDTaking people
  • Yale-New Haven Children's HospitalNew Haven, United StatesContact: E. Vincent Faustino, MD, MHSTaking people
  • Hassenfeld Children's HospitalNew York, United StatesContact: Sandra DeygooTaking people
  • New York - Presbyterian HospitalNew York, United StatesContact: Oleksiy Svezhenets, MDTaking people
  • University of OklahomaOklahoma City, United StatesContact: Tracy JonesTaking people
  • Children's Hospital of Illinois at OSF-Saint Francis Medical CenterPeoria, United StatesContact: Carleen ChaputTaking people
  • Children's Hospital of PhiladelphiaPhiladelphia, United StatesContact: Alanah McKelveyTaking people
  • Children's Hospital of RichmondRichmond, United StatesContact: E. Vincent Faustino, MD, MHSNo longer taking part
  • Golisano Children's HospitalRochester, United StatesContact: Eileen TaillieTaking people
  • Children's Hospital St. LouisSt Louis, United StatesContact: Jessica Archie-DilworthTaking people
  • Johns Hopkins All Children'sSt. Petersburg, United StatesContact: Lexi DallasTaking people
  • Maria Fareri Children's HospitalValhalla, United StatesContact: Sere PolitanoTaking people

About the trial

What the trial wants to find out

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.

The 5 groups in the trial

  • Enoxaparin (Older Children Prophylactic)Treatment being tested

    Prophylactic dose of enoxaparin for older children 1-17 years old.

    Treatment: Enoxaparin

  • Control (Older Children)No study treatment, for comparison

    Usual care without placebo for older children 1-17 years old.

  • Enoxaparin (Infants Therapeutic High Anti-Xa Target)Treatment being tested

    Therapeutic dose of enoxaparin for infants \<1 year old with anti-Xa target of \>0.5-1 IU/mL.

    Treatment: Enoxaparin

  • Enoxaparin (Infants Therapeutic Low Anti-Xa Target)Treatment being tested

    Therapeutic dose of enoxaparin for infants \<1 year old with anti-Xa target of 0.2-0.5 IU/mL.

    Treatment: Enoxaparin

  • Control (Infants)No study treatment, for comparison

    Usual care without placebo for infants \<1 year old.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Age-dependent Heterogeneity in the Efficacy of Prophylaxis With Enoxaparin Against Catheter-associated Thrombosis in Critically Ill Children
Record updated
8 June 2026