Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies (CRETE)
Deep Venous Thrombosis
About this trial
This is an interventional prevention trial for Deep Venous Thrombosis focused on measuring child, critical illness, venous thromboembolism, enoxaparin, thrombin generation, bleed
Eligibility Criteria
Inclusion criteria
- >36 weeks corrected gestational to <17 years old
- <24 hours after insertion of an untunneled CVC
- CVC inserted in the internal jugular or femoral vein
Exclusion criteria
- Radiologic diagnosis of CADVT in the site of insertion in prior 6 weeks
- Currently receiving an antithrombotic agent, e.g., LMWH, UFH, warfarin and aspirin, but not UFH at dose to maintain patency of a vascular catheter
- 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
- Surgery in the prior 7 days
- Major trauma in the prior 7 days
- Presence of coagulopathy, i.e., INR >2.0, aPTT >50 seconds or platelet count <50 x 10^3/mcL
- Presence of renal failure, i.e., creatinine clearance <30 mL/min/1.73 m2
- Known hypersensitivity to heparin or pork products
- Laboratory confirmed HIT
- Current pregnancy or lactation
- Presence of an epidural catheter
- Limitation of care
- Previous enrollment in the CRETE Studies
Sites / Locations
- Children's of AlabamaRecruiting
- Children's Hospital ColoradoRecruiting
- Yale-New Haven Children's HospitalRecruiting
- Johns Hopkins All Children'sRecruiting
- Stead Family Children's HospitalRecruiting
- Children's Hospital St. LouisRecruiting
- Hassenfeld Children's HospitalRecruiting
- New York Presbyterian HospitalRecruiting
- Golisano Children's HospitalRecruiting
- Maria Fareri Children's HospitalRecruiting
- Nationwide Children's HospitalRecruiting
- University of OklahomaRecruiting
- Penn State Hershey Children's HospitalRecruiting
- Children's Hospital of Philadelphia
- Children's Hospital of RichmondRecruiting
- Children's Hospital WisconsinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
No Intervention
Experimental
Experimental
No Intervention
Enoxaparin (Older Children Prophylactic)
Control (Older Children)
Enoxaparin (Infants Therapeutic High Anti-Xa Target)
Enoxaparin (Infants Therapeutic Low Anti-Xa Target)
Control (Infants)
Prophylactic dose of enoxaparin for older children 1-17 years old.
Usual care without placebo for older children 1-17 years old.
Therapeutic dose of enoxaparin for infants <1 year old with anti-Xa target of >0.5-1 IU/mL.
Therapeutic dose of enoxaparin for infants <1 year old with anti-Xa target of 0.2-0.5 IU/mL.
Usual care without placebo for infants <1 year old.