Your session is about to expire
← Back to Search
Anticoagulant
Enoxaparin for Blood Clot Prevention (CRETE Trial)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up maximum of 36 hours after the last dose of enoxaparin
Awards & highlights
CRETE Trial 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.
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.
CRETE Trial 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.
Select...
My central venous catheter is in my neck or upper thigh.
CRETE Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of children with CADVT
Secondary outcome measures
Number of children with any VTE
Number of children with any bleeding
Number of children with clinically apparent CADVT
+3 moreCRETE 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
Who is running the clinical trial?
Children's Hospital Medical Center, CincinnatiOTHER
815 Previous Clinical Trials
6,531,333 Total Patients Enrolled
Children's Healthcare of AtlantaOTHER
165 Previous Clinical Trials
104,872 Total Patients Enrolled
Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,183 Total Patients Enrolled
1 Trials studying Deep Vein Thrombosis
51 Patients Enrolled for Deep Vein Thrombosis
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What indications does Enoxaparin have the most evidence for?
"Enoxaparin is commonly used to treat acute chest syndrome. This medication can also be given to outpatients, angina, unstable, and ischemia patients."
Answered by AI
Is this the first time Enoxaparin has been studied?
"Enoxaparin was first trialled at Oregon Health & Science University in 2014 and, to date, there have been 170 completed clinical studies. There are 24 more ongoing trials being conducted, many of which are based in Saint Louis, Missouri."
Answered by AI
In how many locations are hospitals conducting this research?
"There are 16 clinical trial sites enrolling patients for this study. The locations are located in Saint Louis, Saint Petersburg and Rochester along with other locations 16 other locations. If you are considering participating in this trial, it is helpful to select the site closest to you to minimize travel demands."
Answered by AI
Are there any open appointment times for this research program?
"This study, which was last updated on 11/3/2022 according to clinicaltrials.gov, is still recruiting patients. The posting for this trial went up on 5/11/2022."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger