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Catheter-Related Early Thromboprophylaxis With Enoxaparin (CRETE) Trial

NCT03003390 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2020-07-13

Study results available
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Summary

The purpose of this phase 2a, multi-center, randomized controlled study, is to explore the efficacy of early prophylaxis against catheter-associated deep venous thrombosis (CADVT) in critically ill children.

Conditions

  • Deep Venous Thrombosis

Interventions

DRUG

Enoxaparin

The clinical nurse will give enoxaparin subcutaneously every 12 hours at the currently used starting dose of 0.75 mg/kg for children ≤2 months old or 0.5 mg/kg (maximum of 40 mg) for older children. The 1st dose will be given \<24 hours after insertion of the catheter. Doses will be adjusted to target an anti-Xa level of 0.2-0.5 IU/mL.

Sponsors & Collaborators

  • St. Louis Children's Hospital

    collaborator OTHER

  • Dell Children's Medical Center of Central Texas

    collaborator OTHER

  • Children's Hospital and Health System Foundation, Wisconsin

    collaborator OTHER

  • Weill Medical College of Cornell University

    collaborator OTHER

  • Maria Fareri Children's Hospital

    collaborator UNKNOWN

  • University of Rochester

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • E. Vincent S Faustino, MD, MHS · Associate Professor of Pediatrics, Yale School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-05
Primary Completion
2019-08-16
Completion
2019-08-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03003390 on ClinicalTrials.gov