Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies

Launched by YALE UNIVERSITY · Jun 7, 2021

Keywords

ClinConnect Summary

The CRETE Studies are investigating how well a medication called enoxaparin can help prevent a serious condition known as deep venous thrombosis (DVT) in critically ill children who have a central venous catheter (CVC) placed. DVT is when a blood clot forms in a deep vein, which can happen more frequently in patients with catheters. The study aims to understand if the effectiveness of enoxaparin varies with age, so they are looking at children from 36 weeks corrected gestational age up to 17 years old who have had a CVC inserted within the last 24 hours.

To participate in the trial, children must meet certain criteria. They should be in the specified age range and have a CVC placed in either the internal jugular or femoral vein. However, children who have had recent bleeding issues, major surgery, or trauma, or who are receiving other blood-thinning medications will not be eligible. If enrolled, participants will receive enoxaparin and will be closely monitored for any potential side effects or complications. This study is currently recruiting participants, and it’s a chance to contribute to important research that could improve care for critically ill children.

Gender

ALL

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