RECRUITINGPhase 2 / Phase 3INTERVENTIONAL
Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies
Age-dependent Heterogeneity in the Efficacy of Prophylaxis With Enoxaparin Against Catheter-associated Thrombosis in Critically Ill Children
About This Trial
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 May Be Eligible (Plain English)
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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Enoxaparin
Enoxaparin is a LMWH produced from UFH that exerts its anticoagulant effects by binding to and inducing a conformational change in antithrombin to accelerate the inactivation of factor Xa and thrombin. Age-specified dose of enoxaparin will be administered within 24 hours after insertion of the CVC with the dose subsequently adjusted to pre-specified anti-Xa target.
Locations (20)
Children's of Alabama
Birmingham, Alabama, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Yale-New Haven Children's Hospital
New Haven, Connecticut, United States
University of Florida -UF Health
Gainesville, Florida, United States
Johns Hopkins All Children's
St. Petersburg, Florida, United States
Children's Hospital of Illinois at OSF Saint Francis Medical Center
Peoria, Illinois, United States
Stead Family Children's Hospital
Iowa City, Iowa, United States
Children's Hospital St. Louis
St Louis, Missouri, United States
Hassenfeld Children's Hospital
New York, New York, United States
New York Presbyterian Hospital
New York, New York, United States
Golisano Children's Hospital
Rochester, New York, United States
Maria Fareri Children's Hospital
Valhalla, New York, United States
UH Rainbow Babies & Children's Hospital
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Dell Children's Medical Canter
Austin, Texas, United States
UTSW Medical Center; Children's Medical Center of Dallas
Dallas, Texas, United States