Deep Venous ThrombosisPhase 2/3CRETENCT04924322
Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies
A Phase 2/3 study testing Enoxaparin in people with Deep Venous Thrombosis, run by Yale University at 22 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Deep Venous Thrombosis
- What is being tested?
- Enoxaparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 22 sitesUnited States
- Study dates
- 11 May 2022to 31 Aug 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- >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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
22 sites in 1 country. Contact the study team or a site near you to ask about taking part.
22 sites in 1 country
United States22 sites, 20 recruiting
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Rachel Greer, Rachel.Greer@childrenscolorado.org
Matt Leroue, MD
- Recruiting
Dell Children's Medical Canter
Austin, Texas, 78723
Michael Box, michael.box@ascension-external.org
Elizabeth Wei, MD
- Recruiting
Children's of Alabama
Birmingham, Alabama, 35233
Meghan Murdock, RN, Mmdmurdock@uabmc.edu
Michele Kong, MD
- Recruiting
UH Rainbow Babies & Children's Hospital
Cleveland, Ohio, 44106
Raj Rasal, rajashri.rasal@uhhospitals.org
SaTia Sinclair, satia.sinclair@uhhospitals.org
- Withdrawn
Nationwide Children's Hospital
Columbus, Ohio, 43205
- Recruiting
UTSW Medical Center; Children's Medical Center of Dallas
Dallas, Texas, 75235
Teddy Muisyo, MD, Teddy.Muisyo@UTSouthwestern.edu
Selby Chu, MD, Selby.Chu@UTSouthwestern.edu
- Recruiting
University of Florida -UF Health
Gainesville, Florida, 32610
Melissa Lingus, Melissa.Lingis@peds.ufl.edu
Jose Cardenas, MD
- Recruiting
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, 17033
Debbie Spear, RN, dspear@pennstatehealth.psu.edu
Elizabeth Kerris, MD
- Recruiting
Stead Family Children's Hospital
Iowa City, Iowa, 52242
Maureen Austin, RN, MPH, BSN, Maureen-Austin@uiowa.edu
Mahil Rao
- Recruiting
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Masson Spriggs, SpriggsMK@archildrens.org
Erin Bennett, MD
- Recruiting
Children's Hospital Wisconsin
Milwaukee, Wisconsin, 53226
Sadaf Shad, MD, sshad@mcw.edu
Hilary Schreiber, MD
- Recruiting
Yale-New Haven Children's Hospital
New Haven, Connecticut, 06520
E. Vincent Faustino, MD, MHS
Michelle Ecarma, michelle.ecarma@yale.edu
- Recruiting
Hassenfeld Children's Hospital
New York, New York, 10016
Sandra Deygoo, nagamah.deygoo@nyulangone.org
Michelle Ramirez, MD
- Recruiting
New York Presbyterian Hospital
New York, New York, 10065
Oleksiy Svezhenets, MD, ols4009@med.cornell.edu
Marianne Nellis, MD
- Recruiting
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Tracy Jones, Tracy-Jones@ouhsc.edu
Christine Allen, MD
- Recruiting
Children's Hospital of Illinois at OSF Saint Francis Medical Center
Peoria, Illinois, 61637
Carleen Chaput, Carleen.M.Chaput@osfhealthcare.org
Madhuradhar Chegondi, MD
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Alanah McKelvey, mckelveya@chop.edu
Christine Glau, MD
- Withdrawn
Children's Hospital of Richmond
Richmond, Virginia, 23219
- Recruiting
Golisano Children's Hospital
Rochester, New York, 14642
Eileen Taillie, Eileen_Taillie@URMC.Rochester.edu
Jill Cholette, MD
- Recruiting
Children's Hospital St. Louis
St Louis, Missouri, 63110
Jessica Archie-Dilworth, j.archie-dilworth@wustl.edu
Michael Kramer, MD
- Recruiting
Johns Hopkins All Children's
St. Petersburg, Florida, 33701
Lexi Dallas, adallas2@jhmi.edu
Anthony Sochet, MD
- Recruiting
Maria Fareri Children's Hospital
Valhalla, New York, 10595
Sere Politano, Sere.Politano@wmchealth.org
Matthew Pinto, MD
About this study
Official title: Age-dependent Heterogeneity in the Efficacy of Prophylaxis With Enoxaparin Against Catheter-associated Thrombosis in Critically Ill Children
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.
Read the detailed description
Pediatric venous thromboembolism (VTE), which is predominantly deep venous thrombosis (DVT), is a top contributor to harm in hospitalized children. Its incidence increased by >300% in the past 2 decades. Critical illness and central venous catheter (CVC) are the most important risk factors for VTE in children. Among critically ill children, the risk of CVC-associated DVT (CADVT) is as high as 54% with 72% of cases in infants <1-year old. Pharmacologic prophylaxis is the most effective strategy against VTE in adults. However, due to paucity of age-appropriate evidence on its efficacy against CADVT, pharmacologic prophylaxis is uncommon in children. Extrapolation of evidence from adults is not appropriate because the hemostatic system changes significantly with age. The investigators recently completed a Bayesian phase 2b randomized clinical trial. In this trial, the investigators randomized critically ill children to early administration of prophylactic dose of enoxaparin, the most commonly used anticoagulant for prophylaxis, or usual care. Prophylaxis with enoxaparin appeared to reduce the risk of CADVT by half. In post hoc analyses, reduction was limited to older children 1-17 years old. The goal of the CRETE Studies is to investigate this newly identified age-dependent heterogeneity in the efficacy of enoxaparin in reducing the risk of CADVT in critically ill children. To achieve this goal, the investigators aim (1) to confirm the efficacy and safety of early administration of prophylactic dose of enoxaparin in reducing the risk of CADVT in critically ill older children; (2) to determine the efficacy and safety of early administration of therapeutic dose of enoxaparin in reducing the risk of CADVT in critically ill infants; and, (3) to probe the mechanisms that underly the age-dependent heterogeneity in the efficacy of enoxaparin in reducing the risk of CADVT in critically ill children. The investigators will conduct 2 multicenter Bayesian explanatory randomized clinical trials in parallel to address Specific Aims 1 and 2. Depending on age, subjects will be randomized to different doses of enoxaparin vs usual care. Subjects will be systematically assessed for the development of CADVT using ultrasonography and clinically for bleeding. Using plasma obtained from subjects in the 2 trials, the investigators will conduct an exploratory mechanistic nested case-control study to address Specific Aim 3. Biomarkers of selected mechanisms underlying CVC-associated thrombus formation, particularly thrombin generation, will be compared between subjects with and without CADVT. The investigators will use Bayesian methods to improve the efficiency in the conduct and analyses of these studies. The CRETE Studies will provide high-quality age-appropriate evidence that will inform preventive strategies against CADVT and decrease harm in hospitalized children.
- Conditions
- Deep Venous Thrombosis
- Being tested
- Enoxaparin
- Keywords
- child, critical illness, venous thromboembolism, enoxaparin, thrombin generation, bleed
- Medical subject headings
- Venous Thrombosis, Critical Illness, Venous Thromboembolism, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnoxaparinDrug
Also called Lovenox, Clexane
Enoxaparin is a LMWH produced from UFH that exerts its anticoagulant effects by binding to and inducing a conformational change in antithrombin to accelerate the inactivation of factor Xa and thrombin. Age-specified dose of enoxaparin will be administered within 24 hours after insertion of the CVC with the dose subsequently adjusted to pre-specified anti-Xa target.
| Study group | Role | What they receive |
|---|---|---|
| Enoxaparin (Older Children Prophylactic) | Experimental | Prophylactic dose of enoxaparin for older children 1-17 years old. Receives: Drug: Enoxaparin |
| Control (Older Children) | No intervention | Usual care without placebo for older children 1-17 years old. |
| Enoxaparin (Infants Therapeutic High Anti-Xa Target) | Experimental | Therapeutic dose of enoxaparin for infants <1 year old with anti-Xa target of >0.5-1 IU/mL. Receives: Drug: Enoxaparin |
| Enoxaparin (Infants Therapeutic Low Anti-Xa Target) | Experimental | Therapeutic dose of enoxaparin for infants <1 year old with anti-Xa target of 0.2-0.5 IU/mL. Receives: Drug: Enoxaparin |
| Control (Infants) | No intervention | Usual care without placebo for infants <1 year old. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of children with CADVT
Thrombus in the central vein where the CVC was inserted that is diagnosed with systematic ultrasonographic surveillance.
Measured: Up to removal of CVC (maximum of 28 days)
Secondary outcomes (6)
Number of children with any VTE
Thrombus in the deep vein of any extremity or PE that is confirmed radiologically
Measured: Up to removal of CVC (maximum of 28 days)
Number of children with clinically apparent CADVT
Any CADVT, except one that is only diagnosed with the systematic ultrasonographic surveillance.
Measured: Up to removal of CVC (maximum of 28 days)
Number of children with clinically apparent VTE
Any VTE, except one that is only diagnosed with the systematic ultrasonographic surveillance.
Measured: Up to removal of CVC (maximum of 28 days)
Number of children with clinically relevant bleeding
Bleeding that is fatal, with drop in hemoglobin by ≥2 g/dl in 24 hours, requires medical or surgical intervention to restore hemostasis, or in the retroperitoneum, pulmonary or central nervous system.
Measured: Maximum of 36 hours after the last dose of enoxaparin
Number of children with any bleeding
Any overt or macroscopic evidence of bleeding.
Measured: Maximum of 36 hours after the last dose of enoxaparin
Number of children with heparin-induced thrombocytopenia
Unexplained drop in platelet count to <50 x 10^3/mcL or by 50 percent of baseline platelet count in the ICU within 21 days following exposure to heparin, and with a positive anti-platelet factor 4 antibody.
Measured: Maximum of 36 hours after the last dose of enoxaparin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start11 May 2022
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deep Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Older children 1-17 years old and infants \<1 year old will be randomized separately. Older children will be randomized 2:1 to prophylactic dose of enoxaparin or control stratified by age. Infants will be randomized 1:1:1 to therapeutic dose of enoxaparin with high or low anti-Xa target or control stratified by age.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Colorado, Children's Hospital of Philadelphia, BJC HealthCare, Medical College of Wisconsin, Children's of Alabama, Golisano Children's Hospital, Maria Fareri Children's Hospital, Nationwide Children's Hospital, New York Presbyterian Hospital, Penn State University, University of Iowa, Johns Hopkins All Children's Hospital, University of Oklahoma, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Children's Hospital of Illinois at Peoria, Hassenfeld Children's Hospital
- Responsible party
- Principal investigator, E. Vincent S. Faustino, Yale University
- Investigators
- E. Vincent Faustino, MD, MHS, Principal investigator, Associate Professor of Pediatrics, Yale School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924322
- Sponsor's protocol ID
- 2000030683
- Other IDs
- 1R01HD106326-01
- Acronym
- CRETE
- Status last verified
- Jun 2026
- First submitted
- 7 Jun 2021
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Faustino EVS, Kandil SB, Leroue MK, Sochet AA, Kong M, Cholette JM, Nellis ME, Pinto MG, Chegondi M, Ramirez M, Schreiber H, Kerris EWJ, Glau CL, Kolmar A, Muisyo TM, Sharathkumar A, Polikoff L, Silva CT, Ehrlich L, Navarro OM, Spinella PC, Raffini L, Taylor SN, McPartland T, Shabanova V; Catheter-Related Early Thromboprophylaxis with Enoxaparin (CRETE) Studies Investigators and the Pediatric Critical Care Blood Research Network (BloodNet) of the Pediatric Acute Lung Injury and Sepsis Investigators Network (PALISI). Protocol for the Catheter-Related Early Thromboprophylaxis With Enoxaparin (CRETE) Studies. Pediatr Crit Care Med. 2025 Jan 1;26(1):e95-e105. doi: 10.1097/PCC.0000000000003648. Epub 2024 Nov 20.
PubMed 39560771
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-dependent Heterogeneity in the Efficacy of Prophylaxis With Enoxaparin Against Catheter-associated Thrombosis in Critically Ill Children
- ClinicalTrials.gov ID
- NCT04924322
- Acronym / sponsor ID
- CRETE / 2000030683
- Conditions
- Deep Venous Thrombosis
- Keywords
- child, critical illness, venous thromboembolism, enoxaparin, thrombin generation, bleed
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital Colorado, Children's Hospital of Philadelphia, BJC HealthCare, Medical College of Wisconsin, Children's of Alabama, Golisano Children's Hospital, Maria Fareri Children's Hospital, Nationwide Children's Hospital, New York Presbyterian Hospital, Penn State University, University of Iowa, Johns Hopkins All Children's Hospital, University of Oklahoma, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Children's Hospital of Illinois at Peoria, Hassenfeld Children's Hospital
- Study start
- 11 May 2022 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pediatric venous thromboembolism (VTE), which is predominantly deep venous thrombosis (DVT), is a top contributor to harm in hospitalized children. Its incidence increased by >300% in the past 2 decades. Critical illness and central venous catheter (CVC) are the most important risk factors for VTE in children. Among critically ill children, the risk of CVC-associated DVT (CADVT) is as high as 54% with 72% of cases in infants <1-year old. Pharmacologic prophylaxis is the most effective strategy against VTE in adults. However, due to paucity of age-appropriate evidence on its efficacy against CADVT, pharmacologic prophylaxis is uncommon in children. Extrapolation of evidence from adults is not appropriate because the hemostatic system changes significantly with age. The investigators recently completed a Bayesian phase 2b randomized clinical trial. In this trial, the investigators randomized critically ill children to early administration of prophylactic dose of enoxaparin, the most commonly used anticoagulant for prophylaxis, or usual care. Prophylaxis with enoxaparin appeared to reduce the risk of CADVT by half. In post hoc analyses, reduction was limited to older children 1-17 years old. The goal of the CRETE Studies is to investigate this newly identified age-dependent heterogeneity in the efficacy of enoxaparin in reducing the risk of CADVT in critically ill children. To achieve this goal, the investigators aim (1) to confirm the efficacy and safety of early administration of prophylactic dose of enoxaparin in reducing the risk of CADVT in critically ill older children; (2) to determine the efficacy and safety of early administration of therapeutic dose of enoxaparin in reducing the risk of CADVT in critically ill infants; and, (3) to probe the mechanisms that underly the age-dependent heterogeneity in the efficacy of enoxaparin in reducing the risk of CADVT in critically ill children. The investigators will conduct 2 multicenter Bayesian explanatory randomized clinical trials in parallel to address Specific Aims 1 and 2. Depending on age, subjects will be randomized to different doses of enoxaparin vs usual care. Subjects will be systematically assessed for the development of CADVT using ultrasonography and clinically for bleeding. Using plasma obtained from subjects in the 2 trials, the investigators will conduct an exploratory mechanistic nested case-control study to address Specific Aim 3. Biomarkers of selected mechanisms underlying CVC-associated thrombus formation, particularly thrombin generation, will be compared between subjects with and without CADVT. The investigators will use Bayesian methods to improve the efficiency in the conduct and analyses of these studies. The CRETE Studies will provide high-quality age-appropriate evidence that will inform preventive strategies against CADVT and decrease harm in hospitalized children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
- Model description
- Older children 1-17 years old and infants <1 year old will be randomized separately. Older children will be randomized 2:1 to prophylactic dose of enoxaparin or control stratified by age. Infants will be randomized 1:1:1 to therapeutic dose of enoxaparin with high or low anti-Xa target or control stratified by age.
| Arm | Type | Receives |
|---|---|---|
| Enoxaparin (Older Children Prophylactic) | Experimental | Drug: EnoxaparinProphylactic dose of enoxaparin for older children 1-17 years old. |
| Control (Older Children) | No intervention | –Usual care without placebo for older children 1-17 years old. |
| Enoxaparin (Infants Therapeutic High Anti-Xa Target) | Experimental | Drug: EnoxaparinTherapeutic dose of enoxaparin for infants <1 year old with anti-Xa target of >0.5-1 IU/mL. |
| Enoxaparin (Infants Therapeutic Low Anti-Xa Target) | Experimental | Drug: EnoxaparinTherapeutic dose of enoxaparin for infants <1 year old with anti-Xa target of 0.2-0.5 IU/mL. |
| Control (Infants) | No intervention | –Usual care without placebo for infants <1 year old. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- >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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnoxaparinAlso: Lovenox, ClexaneEnoxaparin is a LMWH produced from UFH that exerts its anticoagulant effects by binding to and inducing a conformational change in antithrombin to accelerate the inactivation of factor Xa and thrombin. Age-specified dose of enoxaparin will be administered within 24 hours after insertion of the CVC with the dose subsequently adjusted to pre-specified anti-Xa target. | Drug | Enoxaparin (Infants Therapeutic High Anti-Xa Target), Enoxaparin (Infants Therapeutic Low Anti-Xa Target), Enoxaparin (Older Children Prophylactic) |
Primary outcome
Number of children with CADVT
Time frame: Up to removal of CVC (maximum of 28 days)
Thrombus in the central vein where the CVC was inserted that is diagnosed with systematic ultrasonographic surveillance.
6 secondary outcomes
Number of children with any VTE
Time frame: Up to removal of CVC (maximum of 28 days)
Number of children with clinically apparent CADVT
Time frame: Up to removal of CVC (maximum of 28 days)
Number of children with clinically apparent VTE
Time frame: Up to removal of CVC (maximum of 28 days)
Number of children with clinically relevant bleeding
Time frame: Maximum of 36 hours after the last dose of enoxaparin
Number of children with any bleeding
Time frame: Maximum of 36 hours after the last dose of enoxaparin
Number of children with heparin-induced thrombocytopenia
Time frame: Maximum of 36 hours after the last dose of enoxaparin
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Derived from this study: PubMed 39560771Faustino EVS, Kandil SB, Leroue MK, Sochet AA, Kong M, Cholette JM, Nellis ME, Pinto MG, Chegondi M, Ramirez M, Schreiber H, Kerris EWJ, Glau CL, Kolmar A, Muisyo TM, Sharathkumar A, Polikoff L, Silva CT, Ehrlich L, Navarro OM, Spinella PC, Raffini L, Taylor SN, McPartland T, Shabanova V; Catheter-Related Early Thromboprophylaxis with Enoxaparin (CRETE) Studies Investigators and the Pediatric Critical Care Blood Research Network (BloodNet) of the Pediatric Acute Lung Injury and Sepsis Investigators Network (PALISI). Protocol for the Catheter-Related Early Thromboprophylaxis With Enoxaparin (CRETE) Studies. Pediatr Crit Care Med. 2025 Jan 1;26(1):e95-e105. doi: 10.1097/PCC.0000000000003648. Epub 2024 Nov 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
E. Vincent Faustino, MD, MHS principal investigator
Associate Professor of Pediatrics, Yale School of Medicine
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Enoxaparin in people with Deep Venous Thrombosis, run by Yale University at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact E. Vincent Faustino, MD, MHS (203-785-4651, vince.faustino@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of children with CADVT (time frame: Up to removal of CVC (maximum of 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04924322, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.