Recruiting
Phase 2
Phase 3

Enoxaparin

Sponsor:

Yale University

Code:

NCT04924322

Conditions

Deep Venous Thrombosis

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Enoxaparin

Study Details

Brief 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.

Conditions

Deep Venous Thrombosis

Study ID

NCT04924322

Start date

May 11, 2022

Status verified date

Jun, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

258 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Enoxaparin (Older Children Prophylactic)

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

no intervention: Control (Older Children)

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

experimental: Enoxaparin (Infants Therapeutic High Anti-Xa Target)

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

experimental: Enoxaparin (Infants Therapeutic Low Anti-Xa Target)

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

no intervention: Control (Infants)

Usual care without placebo for infants <1 year old.

Interventions

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 measure

  • Number of children with CADVT [ Time Frame: Up to removal of CVC (maximum of 28 days) ]

Central Contacts and Locations

Central contacts

E. Vincent Faustino, MD, MHS

203-785-4651vince.faustino@yale.edu

Tara McPartland, MSW, MPH

203-737-7173tara.mcpartland@yale.edu

Locations

Children's of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Meghan Murdock, RN

Mmdmurdock@uabmc.edu

Principal Investigator:

Michele Kong, MD

Arkansas Children's Hospital

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

Principal Investigator:

Erin Bennett, MD

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Matt Leroue, MD

Yale-New Haven Children's Hospital

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Principal Investigator:

Vincent Faustino, MD, MHS

University of Florida -UF Health

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Principal Investigator:

Jose Cardenas, MD

Johns Hopkins All Children's

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

Principal Investigator:

Anthony Sochet, MD

Children's Hospital of Illinois at OSF Saint Francis Medical Center

Recruiting

Peoria, Illinois, United States, 61637

Contacts

Principal Investigator:

Madhuradhar Chegondi, MD

Stead Family Children's Hospital

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Maureen Austin, RN, MPH, BSN

Maureen-Austin@uiowa.edu

Principal Investigator:

Mahil Rao

Children's Hospital St. Louis

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Jessica Archie-Dilworth

j.archie-dilworth@wustl.edu

Principal Investigator:

Michael Kramer, MD

Hassenfeld Children's Hospital

Recruiting

New York, New York, United States, 10016

Contacts

Principal Investigator:

Michelle Ramirez, MD

New York Presbyterian Hospital

Recruiting

New York, New York, United States, 10065

Contacts

Oleksiy Svezhenets, MD

ols4009@med.cornell.edu

Principal Investigator:

Marianne Nellis, MD

Golisano Children's Hospital

Recruiting

Rochester, New York, United States, 14642

Contacts

Principal Investigator:

Jill Cholette, MD

Maria Fareri Children's Hospital

Recruiting

Valhalla, New York, United States, 10595

Contacts

Principal Investigator:

Matthew Pinto, MD

UH Rainbow Babies & Children's Hospital

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Principal Investigator:

Kenneth Remy, MD

University of Oklahoma

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Principal Investigator:

Christine Allen, MD

Penn State Hershey Children's Hospital

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Principal Investigator:

Elizabeth Kerris, MD

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Alanah McKelvey

mckelveya@chop.edu

Principal Investigator:

Christine Glau, MD

Dell Children's Medical Canter

Recruiting

Austin, Texas, United States, 78723

Contacts

Principal Investigator:

Elizabeth Wei, MD

UTSW Medical Center; Children's Medical Center of Dallas

Recruiting

Dallas, Texas, United States, 75235

Contacts

Principal Investigator:

Teddy Muisyo, MD

Children's Hospital Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Sadaf Shad, MD

sshad@mcw.edu

Principal Investigator:

Hilary Schreiber, MD

More Information

Sponsor

Yale University

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

  • child
  • critical illness
  • venous thromboembolism
  • enoxaparin
  • thrombin generation
  • bleed

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Yale University on 2026-06-08.