RecruitingPhase 2/3

Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies

United States258 participantsStarted 2022-05-11

Plain-language summary

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.

Who can participate

Age range17 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. \>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

Exclusion criteria

✕. 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
✕. Major trauma in the prior 7 days
✕. Presence of coagulopathy, i.e., INR \>2.0, aPTT \>50 seconds or platelet count \<50 x 10\^3/mcL
✕. Presence of renal failure, i.e., creatinine clearance \<30 mL/min/1.73 m2
✕. Known hypersensitivity to heparin or pork products

What they're measuring

Number of children with CADVT

Timeframe: Up to removal of CVC (maximum of 28 days)

Trial details

NCT IDNCT04924322

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-30

Contact for this trial

E. Vincent Faustino, MD, MHS

203-785-4651 vince.faustino@yale.edu

View on ClinicalTrials.gov More Deep Venous Thrombosis trials