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New treatment option for Deep Venous Thrombosis
Official title Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies
ClinicalTrials.gov ID: NCT04924322
What this study is testing
What is Enoxaparin?
Enoxaparin is an investigational medicine, being studied as a potential treatment for deep venous thrombosis.
Also referred to as Lovenox, Clexane.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 17
You may be able to join if
- \>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
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Little Rock, Arkansas, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Gainesville, Florida, United States
- St. Petersburg, Florida, United States
- Peoria, Illinois, United States
- Iowa City, Iowa, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Rochester, New York, United States
- Valhalla, New York, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Hershey, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- Richmond, Virginia, United States
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Little Rock, Arkansas, United States; Aurora, Colorado, United States; New Haven, Connecticut, United States; Gainesville, Florida, United States; St. Petersburg, Florida, United States and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.