NCT04924322 Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies
| NCT ID | NCT04924322 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Yale University |
| Condition | Deep Venous Thrombosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 258 participants |
| Start Date | 2022-05-11 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 258 participants in total. It began in 2022-05-11 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
E. Vincent Faustino, MD, MHS
PRINCIPAL INVESTIGATOR
Associate Professor of Pediatrics, Yale School of Medicine
Frequently Asked Questions
Who can join the NCT04924322 clinical trial?
This trial is open to participants of all sexes, up to 17 Years, studying Deep Venous Thrombosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04924322 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04924322 currently recruiting?
Yes, NCT04924322 is actively recruiting participants. Contact the research team at vince.faustino@yale.edu for enrollment information.
Where is the NCT04924322 trial being conducted?
This trial is being conducted at Birmingham, United States, Little Rock, United States, Aurora, United States, New Haven, United States and 11 additional locations.
Who is sponsoring the NCT04924322 clinical trial?
NCT04924322 is sponsored by Yale University. The principal investigator is E. Vincent Faustino, MD, MHS at Associate Professor of Pediatrics, Yale School of Medicine. The trial plans to enroll 258 participants.