Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

258 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-11

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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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

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Deep Venous Thrombosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

The CRETE Studies are open-label with blinded endpoint. Systematic ultrasonographic assessment will be performed with the images blindly and centrally adjudicated.

Study Groups

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Enoxaparin (Older Children Prophylactic)

Prophylactic dose of enoxaparin for older children 1-17 years old.

Group Type EXPERIMENTAL

Enoxaparin

Intervention Type DRUG

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.

Control (Older Children)

Eligibility Criteria

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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

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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E. Vincent S. Faustino

Professor of Pediatrics (Critical Care)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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E. Vincent Faustino, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Pediatrics, Yale School of Medicine

Reach out to these primary contacts for questions about participation or study logistics.

E. Vincent Faustino, MD, MHS

Role: CONTACT

[email protected]

203-785-4651

Tara McPartland, MSW, MPH

Role: CONTACT

[email protected]

203-737-7173

Facility Contacts

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Meghan Murdock, RN

Role: primary

[email protected]

Masson Spriggs

Role: primary

[email protected]

Rachel Greer

Role: primary

[email protected]

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED

PMID: 39560771 (View on PubMed)

Other Identifiers

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1R01HD106326-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000030683

Identifier Type: -

Identifier Source: org_study_id

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Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies

Study Results

Basic Information

Brief Summary

Related Clinical Trials

Catheter-Related Early Thromboprophylaxis With Enoxaparin (CRETE) Trial

Thrombelastography Based Dosing of Enoxaparin

Evaluation of Chemical Venous Thromboembolism Prophylaxis in Trauma

A Clinical Cohort Study of Safety and Effectiveness of Venous Thromboembolism Prophylaxis in Critical Ill Patients

Enoxaparin in Children With Asymptomatic Venous Thrombosis After Pediatric Cardiac Surgery

Detailed Description

Conditions

Study Design

Study Groups

Enoxaparin (Older Children Prophylactic)

Enoxaparin

Control (Older Children)

Enoxaparin (Infants Therapeutic High Anti-Xa Target)

Enoxaparin

Enoxaparin (Infants Therapeutic Low Anti-Xa Target)

Enoxaparin

Control (Infants)

Interventions

Enoxaparin

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

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 OSF Saint Francis Medical Center

Hassenfeld Children's Hospital

Yale University

Responsible Party

E. Vincent S. Faustino

Principal Investigators

E. Vincent Faustino, MD, MHS

Locations

Children's of Alabama

Arkansas Children's Hospital

Children's Hospital Colorado

Yale-New Haven Children's Hospital

University of Florida -UF Health

Johns Hopkins All Children's

Children's Hospital of Illinois at OSF Saint Francis Medical Center

Stead Family Children's Hospital

Children's Hospital St. Louis

Hassenfeld Children's Hospital

New York Presbyterian Hospital

Golisano Children's Hospital

Maria Fareri Children's Hospital

UH Rainbow Babies & Children's Hospital

Nationwide Children's Hospital

University of Oklahoma

Penn State Hershey Children's Hospital

Children's Hospital of Philadelphia

Dell Children's Medical Canter

UTSW Medical Center; Children's Medical Center of Dallas

Children's Hospital of Richmond

Children's Hospital Wisconsin

Countries

Central Contacts

E. Vincent Faustino, MD, MHS

Tara McPartland, MSW, MPH

Facility Contacts

Meghan Murdock, RN

Masson Spriggs