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Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies

RecruitingPhase 2/3

Age-dependent Heterogeneity in the Efficacy of Prophylaxis With Enoxaparin Against Catheter-associated Thrombosis in Critically Ill Children

Who can join

Up to age 17 · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Yale University · Participants: 258 · Started: May 11, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT04924322

Locations in the U.S.

AlabamaChildren's of Alabama, Birmingham
ArkansasArkansas Children's Hospital, Little Rock
ColoradoChildren's Hospital Colorado, Aurora
ConnecticutYale-New Haven Children's Hospital, New Haven
FloridaUniversity of Florida -UF Health, Gainesville
Johns Hopkins All Children's, St. Petersburg
IllinoisChildren's Hospital of Illinois at OSF Saint Francis Medical Center, Peoria
IowaStead Family Children's Hospital, Iowa City
MissouriChildren's Hospital St. Louis, St Louis
New YorkHassenfeld Children's Hospital, New York
New York Presbyterian Hospital, New York
Golisano Children's Hospital, Rochester
Maria Fareri Children's Hospital, Valhalla
OhioUH Rainbow Babies & Children's Hospital, Cleveland
OklahomaUniversity of Oklahoma, Oklahoma City
PennsylvaniaPenn State Hershey Children's Hospital, Hershey
Children's Hospital of Philadelphia, Philadelphia
TexasDell Children's Medical Canter, Austin
UTSW Medical Center; Children's Medical Center of Dallas, Dallas
WisconsinChildren's Hospital Wisconsin, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.