Enoxaparin for Preventing Blood Clots in Critically Ill Children
Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies
Recruiting
Phase 2Phase 3Interventional Study
Deep Venous Thrombosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
Up to 17
Sex
Any
Trial phase
Phase 2/3
Study type
Interventional
Purpose
Prevention
Participants needed
258 (estimated)
Sponsor
Yale University · Other
Who this trial is looking for
This trial is looking for critically ill children aged between 36 weeks and 17 years who have had a specific type of catheter placed. Participants will receive enoxaparin to help reduce the risk of blood clots related to their medical treatment.
Are You a Good Fit for This Trial?
Must not be takingLMWHUFHwarfarinaspirin
Rules you outCoagulopathyRenal failureKnown hypersensitivity to heparin or pork productsLaboratory confirmed HITCurrent pregnancy or lactation
You may be able to join if
I am between 36 weeks corrected gestational age and 17 years old.
I have had an untunneled central venous catheter (CVC) inserted within the last 24 hours.
My CVC was inserted in either my internal jugular or femoral vein.
You may not be able to join if
I have had a diagnosis of blood clots at the insertion site in the last 6 weeks.
I am currently taking any blood-thinning medication.
I have had significant bleeding in the last 60 days.
I have had surgery in the last 7 days.
I have experienced major trauma in the last 7 days.
I have a blood clotting disorder.
I have kidney failure.
I am allergic to heparin or pork products.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
Sorted by distance from Montana
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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 …
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
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