Actively Recruiting

Phase 2
Phase 3
Age: 0 - 17Years
All Genders
NCT04924322

Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies

Led by Yale University · Updated on 2025-06-11

258

Participants Needed

22

Research Sites

220 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

C

Children's Hospital Colorado

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies

Who Can Participate

Age: 0 - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Older than 36 weeks corrected gestational age and younger than 17 years old
  • Less than 24 hours after insertion of an untunneled central venous catheter (CVC)
  • CVC inserted in the internal jugular or femoral vein
Not Eligible

You will not qualify if you...

  • Radiologic diagnosis of catheter-associated deep venous thrombosis (CADVT) at the insertion site within the prior 6 weeks
  • Currently receiving an antithrombotic agent, such as low molecular weight heparin, unfractionated heparin, warfarin, or aspirin (except unfractionated heparin for catheter patency)
  • Clinically relevant bleeding in the prior 60 days, including significant hemoglobin decrease or bleeding requiring medical or surgical intervention
  • Surgery or major trauma in the prior 7 days
  • Coagulopathy with elevated INR, aPTT, or low platelet count
  • Renal failure with creatinine clearance less than 30 mL/min/1.73 m2
  • Known allergy to heparin or pork products
  • Laboratory-confirmed heparin-induced thrombocytopenia (HIT)
  • Current pregnancy or breastfeeding
  • Presence of an epidural catheter
  • Limitations of care
  • Previous enrollment in the CRETE Studies

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 22 locations

1

Children's of Alabama

Birmingham, Alabama, United States, 35233

Actively Recruiting

2

Arkansas Children's Hospital

Little Rock, Arkansas, United States, 72202

Actively Recruiting

3

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

4

Yale-New Haven Children's Hospital

New Haven, Connecticut, United States, 06520

Actively Recruiting

5

University of Florida -UF Health

Gainesville, Florida, United States, 32610

Actively Recruiting

6

Johns Hopkins All Children's

St. Petersburg, Florida, United States, 33701

Actively Recruiting

7

Children's Hospital of Illinois at OSF Saint Francis Medical Center

Peoria, Illinois, United States, 61637

Actively Recruiting

8

Stead Family Children's Hospital

Iowa City, Iowa, United States, 52242

Actively Recruiting

9

Children's Hospital St. Louis

St Louis, Missouri, United States, 63110

Actively Recruiting

10

Hassenfeld Children's Hospital

New York, New York, United States, 10016

Actively Recruiting

11

New York Presbyterian Hospital

New York, New York, United States, 10065

Actively Recruiting

12

Golisano Children's Hospital

Rochester, New York, United States, 14642

Actively Recruiting

13

Maria Fareri Children's Hospital

Valhalla, New York, United States, 10595

Actively Recruiting

14

UH Rainbow Babies & Children's Hospital

Cleveland, Ohio, United States, 44106

Actively Recruiting

15

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Withdrawn

16

University of Oklahoma

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

17

Penn State Hershey Children's Hospital

Hershey, Pennsylvania, United States, 17033

Actively Recruiting

18

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

19

Dell Children's Medical Canter

Austin, Texas, United States, 78723

Actively Recruiting

20

UTSW Medical Center; Children's Medical Center of Dallas

Dallas, Texas, United States, 75235

Actively Recruiting

21

Children's Hospital of Richmond

Richmond, Virginia, United States, 23219

Withdrawn

22

Children's Hospital Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

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Research Team

E

E. Vincent Faustino, MD, MHS

CONTACT

T

Tara McPartland, MSW, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

5

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