Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies
NCT04924322 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 258
Last updated 2025-06-11
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
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.
Sponsors & Collaborators
-
Children's Hospital Colorado
collaborator OTHER -
Children's Hospital of Philadelphia
collaborator OTHER -
BJC HealthCare
collaborator OTHER -
Medical College of Wisconsin
collaborator OTHER -
Children's of Alabama
collaborator OTHER -
Golisano Children's Hospital
collaborator UNKNOWN -
Maria Fareri Children's Hospital
collaborator UNKNOWN -
Nationwide Children's Hospital
collaborator OTHER -
New York Presbyterian Hospital
collaborator OTHER -
Penn State University
collaborator OTHER -
University of Iowa
collaborator OTHER -
Johns Hopkins All Children's Hospital
collaborator OTHER -
University of Oklahoma
collaborator OTHER -
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
collaborator NIH -
Children's Hospital of Illinois OSF Saint Francis Medical Center
collaborator UNKNOWN -
Hassenfeld Children's Hospital
collaborator UNKNOWN -
Yale University
lead OTHER
Principal Investigators
-
E. Vincent Faustino, MD, MHS · Associate Professor of Pediatrics, Yale School of Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-11
- Primary Completion
- 2026-04-30
- Completion
- 2026-07-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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