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Anticoagulant
Enoxaparin for Blood Clot Prevention (CRETE Trial)
Saint Petersburg, FL
Phase 2 & 3
Recruiting
Led By E. Vincent Faustino, MD, MHS
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
>36 weeks corrected gestational to <17 years old
CVC inserted in the internal jugular or femoral vein
Must not have
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
Currently receiving an antithrombotic agent, e.g., LMWH, UFH, warfarin and aspirin, but not UFH at dose to maintain patency of a vascular catheter
Timeline
Screening 3 weeks
Treatment Varies
Follow Up maximum of 36 hours after the last dose of enoxaparin
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether a blood thinner can help reduce the risk of a common complication in kids who need a central venous catheter.
See full description
Who is the study for?
The CRETE Studies are for critically ill children from over 36 weeks gestational age to under 17 years old, who've had a central venous catheter placed in the last 24 hours. The trial excludes those with recent blood clots, bleeding issues, surgery or major trauma within the past week, certain coagulation disorders, severe kidney problems, heparin allergies or pork product sensitivities.Check my eligibility
What is being tested?
This study is testing whether Enoxaparin can prevent blood clots in young patients with central venous catheters. It focuses on how well it works across different ages and aims to reduce the risk of deep vein thrombosis associated with these catheters.See study design
What are the potential side effects?
Enoxaparin may cause side effects such as bleeding complications, irritation at injection site, allergic reactions if sensitive to its components (including pork), and possibly low platelet counts which could increase bleeding risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 36 weeks corrected gestational age and under 17 years old.
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Select...
My central venous catheter is in my neck or upper thigh.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had significant bleeding issues in the last 2 months.
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Select...
I am currently taking blood thinners, but not for a catheter.
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Select...
My kidney function is severely reduced.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ maximum of 36 hours after the last dose of enoxaparin
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~maximum of 36 hours after the last dose of enoxaparin
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of children with CADVT
Secondary study objectives
Number of children with any VTE
Number of children with any bleeding
Number of children with clinically apparent CADVT
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: Enoxaparin (Older Children Prophylactic)Experimental Treatment1 Intervention
Prophylactic dose of enoxaparin for older children 1-17 years old.
Group II: Enoxaparin (Infants Therapeutic Low Anti-Xa Target)Experimental Treatment1 Intervention
Therapeutic dose of enoxaparin for infants \<1 year old with anti-Xa target of 0.2-0.5 IU/mL.
Group III: Enoxaparin (Infants Therapeutic High Anti-Xa Target)Experimental Treatment1 Intervention
Therapeutic dose of enoxaparin for infants \<1 year old with anti-Xa target of \>0.5-1 IU/mL.
Group IV: Control (Older Children)Active Control1 Intervention
Usual care without placebo for older children 1-17 years old.
Group V: Control (Infants)Active Control1 Intervention
Usual care without placebo for infants \<1 year old.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enoxaparin
2017
Completed Phase 4
~32400
Find a Location
Closest Location:University of Oklahoma· Oklahoma City, OK· 159 miles
Who is running the clinical trial?
Children's Hospital of Illinois OSF Saint Francis Medical CenterUNKNOWN
Hassenfeld Children's HospitalUNKNOWN
Children's Hospital Medical Center, CincinnatiOTHER
841 Previous Clinical Trials
6,564,664 Total Patients Enrolled
BJC HealthCareOTHER
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46,424 Total Patients Enrolled
Children's Healthcare of AtlantaOTHER
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107,448 Total Patients Enrolled
Yale UniversityLead Sponsor
1,953 Previous Clinical Trials
3,043,298 Total Patients Enrolled
New York Presbyterian HospitalOTHER
76 Previous Clinical Trials
57,037 Total Patients Enrolled
Children's Hospital ColoradoOTHER
120 Previous Clinical Trials
5,134,324 Total Patients Enrolled
Children's of AlabamaOTHER
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2,717 Total Patients Enrolled
Penn State UniversityOTHER
378 Previous Clinical Trials
130,209 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had surgery in the last week.You have had a serious injury in the past week.You are allergic to heparin or pork products.You have a catheter in your back for pain relief.You cannot participate if you had a central venous catheter inserted less than 24 hours ago.You have been diagnosed with heparin-induced thrombocytopenia (HIT) through laboratory tests.Your blood clotting test results show abnormal values, such as INR greater than 2.0, aPTT greater than 50 seconds, or platelet count less than 50,000 per microliter.I am between 36 weeks corrected gestational age and under 17 years old.I have had significant bleeding issues in the last 2 months.I am currently taking blood thinners, but not for a catheter.My kidney function is severely reduced.My central venous catheter is in my neck or upper thigh.You have been diagnosed with blood clots near the area where a medical device was inserted in the past 6 weeks.Restrictions on medical treatment or care.You have already participated in the CRETE Studies before.
Research Study Groups:
This trial has the following groups:- Group 1: Enoxaparin (Older Children Prophylactic)
- Group 2: Control (Older Children)
- Group 3: Enoxaparin (Infants Therapeutic High Anti-Xa Target)
- Group 4: Enoxaparin (Infants Therapeutic Low Anti-Xa Target)
- Group 5: Control (Infants)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.