Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies

• Status: Not yet recruiting
• Trial end date: 2026-07-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborators: BJC HealthCare; Children's Healthcare of Atlanta; Children's Hospital Colorado; Children's Hospital Medical Center, Cincinnati; Children's Hospital of Philadelphia; Children's of Alabama; Golisano Children's Hospital; Maria Fareri Children's Hospital; Medical College of Wisconsin; Nationwide Children's Hospital; New York Presbyterian Hospital; Penn State University; University of Iowa; Virginia Commonwealth University
• Treatments: Enoxaparin

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