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
This trial does not accept healthy volunteersQualifiers
>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
Design model
Parallel
Treatments tested in this trial
Enoxaparin
DrugEnoxaparin 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.
Treatment groups
258 Participants
are divided into 5 treatment groupsGroup A: Enoxaparin (Older Children Prophylactic)Experimental treatment 1 intervention
Group B: Control (Older Children)No intervention 0 interventions
Group C: Enoxaparin (Infants Therapeutic High Anti-Xa Target)Experimental treatment 1 intervention
Group D: Enoxaparin (Infants Therapeutic Low Anti-Xa Target)Experimental treatment 1 intervention
Group E: Control (Infants)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
Number of children with CADVT
Thrombus in the central vein where the CVC was inserted that is diagnosed with systematic ultrasonographic surveillance.
Time frame
Up to removal of CVC (maximum of 28 days)Secondary outcomes
1
Number of children with any VTE
Thrombus in the deep vein of any extremity or PE that is confirmed radiologically
Time frame
Up to removal of CVC (maximum of 28 days)2
Number of children with clinically apparent CADVT
Any CADVT, except one that is only diagnosed with the systematic ultrasonographic surveillance.
Time frame
Up to removal of CVC (maximum of 28 days)3
Number of children with clinically apparent VTE
Any VTE, except one that is only diagnosed with the systematic ultrasonographic surveillance.
Time frame
Up to removal of CVC (maximum of 28 days)4
Number of children with clinically relevant bleeding
Bleeding that is fatal, with drop in hemoglobin by ≥2 g/dl in 24 hours, requires medical or surgical intervention to restore hemostasis, or in the retroperitoneum, pulmonary or central nervous system.
Time frame
Maximum of 36 hours after the last dose of enoxaparinSponsors and contacts
Click on the lead sponsor to view all of their trials.
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