Catheter-Related Early Thromboprophylaxis With Enoxaparin (CRETE) Trial

• Status: Terminated
• Trial end date: 2019-08-16
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Yale University
• Collaborators: Children's Hospital and Health System Foundation, Wisconsin; Dell Children's Medical Center of Central Texas; Dell Children’s Medical Center of Central Texas; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Maria Fareri Children's Hospital; St. Louis Children's Hospital; University of Rochester Golisano Children's Hospital; Weill Medical College of Cornell University
• Treatments: Enoxaparin

Criteria

Inclusion Criteria

1. Untunneled CVC inserted in the internal jugular or femoral vein within the past 24 hours

2. Child anticipated to stay in the pediatric intensive care unit ≥48 hours

3. CVC anticipated to be required for ≥24 hours

4. >36 weeks corrected gestational age to <18 years old

Exclusion Criteria

1. Coagulopathy (i.e., international normalized ratio >2.0, activated partial thromboplastin time >50 seconds or platelet count <50,000/mm3)

2. Known bleeding disorder

3. Clinically relevant bleeding as defined by the International Society on Thrombosis and Hemostasis (i.e., Hb decreased ≥2 g/dl in 24 hours, required medical or surgical intervention to restore hemostasis, or in a critical organ system [i.e., retroperitoneum, pulmonary, intracranial or central nervous system])

4. <60 days from a clinically relevant bleeding as defined above

5. <7 days after trauma or surgery

6. Anticipated surgery within 48 hours after insertion of the CVC

7. Renal failure (i.e., creatinine clearance <30 mL/min)

8. Presence of epidural catheter

9. Currently taking an antithrombotic agent (e.g., low molecular weight heparin (LMWH), unfractionated heparin (UFH) at therapeutic doses, Coumadin or aspirin)

10. Radiologically documented DVT at the site of insertion of the CVC in the previous 6 weeks

11. Known hypersensitivity to heparin or its components, including pork products

12. History of heparin-induced thrombocytopenia (HIT) (i.e., positive serotonin release assay)

13. Currently pregnant

14. Currently lactating

15. Prior enrollment in the study

16. Limitation of care