Age-dependent Heterogeneity in the Efficacy of Prophylaxis With Enoxaparin Against Catheter-associated Thrombosis in Critically Ill Children
Who is this study for? Patients with Deep Vein Thrombosis
What treatments are being studied? Enoxaparin
Status: Recruiting
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 17
Healthy Volunteers: f
View:
• \>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
Locations
United States
Alabama
Children's of Alabama
RECRUITING
Birmingham
Arkansas
Arkansas Children's Hospital
RECRUITING
Little Rock
Colorado
Children's Hospital Colorado
RECRUITING
Aurora
Connecticut
Yale-New Haven Children's Hospital
RECRUITING
New Haven
Florida
University of Florida -UF Health
RECRUITING
Gainesville
Johns Hopkins All Children's
RECRUITING
St. Petersburg
Iowa
Stead Family Children's Hospital
RECRUITING
Iowa City
Illinois
Children's Hospital of Illinois at OSF Saint Francis Medical Center
RECRUITING
Peoria
Missouri
Children's Hospital St. Louis
RECRUITING
St Louis
New York
Hassenfeld Children's Hospital
RECRUITING
New York
New York Presbyterian Hospital
RECRUITING
New York
Golisano Children's Hospital
RECRUITING
Rochester
Maria Fareri Children's Hospital
RECRUITING
Valhalla
Ohio
UH Rainbow Babies & Children's Hospital
RECRUITING
Cleveland
Nationwide Children's Hospital
WITHDRAWN
Columbus
Oklahoma
University of Oklahoma
RECRUITING
Oklahoma City
Pennsylvania
Penn State Hershey Children's Hospital
RECRUITING
Hershey
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Texas
Dell Children's Medical Canter
RECRUITING
Austin
UTSW Medical Center; Children's Medical Center of Dallas
RECRUITING
Dallas
Virginia
Children's Hospital of Richmond
WITHDRAWN
Richmond
Wisconsin
Children's Hospital Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
E. Vincent Faustino, MD, MHS
vince.faustino@yale.edu
203-785-4651
Backup
Tara McPartland, MSW, MPH
tara.mcpartland@yale.edu
203-737-7173
Time Frame
Start Date: 2022-05-11
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 258
Treatments
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.
Authors
Vincent Faustino
Related Therapeutic Areas
Sponsors
Collaborators: BJC HealthCare, Nationwide Children's Hospital, New York Presbyterian Hospital, Children's Hospital Colorado, Children's of Alabama, Medical College of Wisconsin, Johns Hopkins All Children's Hospital, Children's Hospital of Philadelphia, University of Oklahoma, Maria Fareri Children's Hospital, Golisano Children's Hospital, Children's Hospital of Illinois OSF Saint Francis Medical Center, University of Iowa, Hassenfeld Children's Hospital, Penn State University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Leads: Yale University