Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Yale University
Study ID
NCT04924322
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Deep Venous Thrombosis

Eligibility Criteria

Sex
ALL
Age
N/A - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Enoxaparin — 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.

Study Details

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.

Key Dates

Start date
May 11, 2022
Status verified
Jun 2026
Primary completion
Apr 30, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
258 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Enoxaparin (Older Children Prophylactic)
    Prophylactic dose of enoxaparin for older children 1-17 years old.
  • No Intervention: Control (Older Children)
    Usual care without placebo for older children 1-17 years old.
  • Experimental: Enoxaparin (Infants Therapeutic High Anti-Xa Target)
    Therapeutic dose of enoxaparin for infants \<1 year old with anti-Xa target of \>0.5-1 IU/mL.
  • Experimental: Enoxaparin (Infants Therapeutic Low Anti-Xa Target)
    Therapeutic dose of enoxaparin for infants \<1 year old with anti-Xa target of 0.2-0.5 IU/mL.
  • No Intervention: Control (Infants)
    Usual care without placebo for infants \<1 year old.

Primary Outcome Measure

Number of children with CADVT [ Time Frame: Up to removal of CVC (maximum of 28 days) ]

Central Contacts

Locations (22)

FacilityCityStateZIPSite coordinators
Children's of AlabamaBirminghamAlabama35233
Meghan Murdock, RN
[email protected]
Michele Kong, MD (PRINCIPAL_INVESTIGATOR)
Arkansas Children's HospitalLittle RockArkansas72202
Masson Spriggs
[email protected]
Erin Bennett, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital ColoradoAuroraColorado80045
Rachel Greer
[email protected]
Matt Leroue, MD (PRINCIPAL_INVESTIGATOR)
Yale-New Haven Children's HospitalNew HavenConnecticut06520
E. Vincent Faustino, MD, MHS
Michelle Ecarma
[email protected]
Vincent Faustino, MD, MHS (PRINCIPAL_INVESTIGATOR)
University of Florida -UF HealthGainesvilleFlorida32610
Melissa Lingus
[email protected]
Jose Cardenas, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins All Children'sSt. PetersburgFlorida33701
Anthony Sochet, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of Illinois at OSF Saint Francis Medical CenterPeoriaIllinois61637
Carleen Chaput
[email protected]
Madhuradhar Chegondi, MD (PRINCIPAL_INVESTIGATOR)
Stead Family Children's HospitalIowa CityIowa52242
Maureen Austin, RN, MPH, BSN
[email protected]
Mahil Rao (PRINCIPAL_INVESTIGATOR)
Children's Hospital St. LouisSt LouisMissouri63110
Jessica Archie-Dilworth
[email protected]
Michael Kramer, MD (PRINCIPAL_INVESTIGATOR)
Hassenfeld Children's HospitalNew YorkNew York10016
Sandra Deygoo
[email protected]
Michelle Ramirez, MD (PRINCIPAL_INVESTIGATOR)
New York Presbyterian HospitalNew YorkNew York10065
Oleksiy Svezhenets, MD
[email protected]
Marianne Nellis, MD (PRINCIPAL_INVESTIGATOR)
Golisano Children's HospitalRochesterNew York14642
Eileen Taillie
[email protected]
Jill Cholette, MD (PRINCIPAL_INVESTIGATOR)
Maria Fareri Children's HospitalValhallaNew York10595
Sere Politano
[email protected]
Matthew Pinto, MD (PRINCIPAL_INVESTIGATOR)
UH Rainbow Babies & Children's HospitalClevelandOhio44106
SaTia Sinclair
[email protected]
Kenneth Remy, MD (PRINCIPAL_INVESTIGATOR)
Nationwide Children's HospitalColumbusOhio43205-
University of OklahomaOklahoma CityOklahoma73104
Christine Allen, MD (PRINCIPAL_INVESTIGATOR)
Penn State Hershey Children's HospitalHersheyPennsylvania17033
Debbie Spear, RN
[email protected]
Elizabeth Kerris, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Alanah McKelvey
[email protected]
Christine Glau, MD (PRINCIPAL_INVESTIGATOR)
Dell Children's Medical CanterAustinTexas78723
Elizabeth Wei, MD (PRINCIPAL_INVESTIGATOR)
UTSW Medical Center; Children's Medical Center of DallasDallasTexas75235
Teddy Muisyo, MD
[email protected]
Selby Chu, MD
[email protected]
Teddy Muisyo, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of RichmondRichmondVirginia23219-
Children's Hospital WisconsinMilwaukeeWisconsin53226
Sadaf Shad, MD
[email protected]
Hilary Schreiber, MD (PRINCIPAL_INVESTIGATOR)

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