Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies
ConditionDeep Venous Thrombosis
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
AgeUp to 17
SponsorYale University
About this trial
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 criteria
Qualifiers
>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
Disqualifiers
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
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
Surgery in the prior 7 days
Trial design
Treatments tested in this trial
- Enoxaparin
Treatment groups
258 Participants
are divided into 5 treatment groupsSponsors and collaborators
Yale University
Lead sponsor
Children's Hospital Colorado
Collaborator
Children's Hospital of Philadelphia
Collaborator
BJC HealthCare
Collaborator
Medical College of Wisconsin
Collaborator
Children's of Alabama
Collaborator
Golisano Children's Hospital
Collaborator
Maria Fareri Children's Hospital
Collaborator
Nationwide Children's Hospital
Collaborator
New York Presbyterian Hospital
Collaborator
Penn State University
Collaborator
University of Iowa
Collaborator
Johns Hopkins All Children's Hospital
Collaborator
University of Oklahoma
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Children's Hospital of Illinois at Peoria
Collaborator
Hassenfeld Children's Hospital
Collaborator
Source ClinicalTrials.gov