Collaborative Risk-stratified Investigation in Thrombosis-prone Inpatients With Critical Illness: Anticoagulation With LMWH in Teens for ThromboProphylaxis (CRITICAL-Teens-TP).

Part of paid clinical trials in St. Petersburg, Florida.

Sponsor
Johns Hopkins All Children's Hospital
Study ID
NCT06628778
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Venous Thromboembolism (VTE)

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Enoxaparin — DRUG
    Enoxaparin thromboprophylaxis administered subcutaneously twice daily (every 12 hours) from enrollment through pediatric intensive care unit discharge

Study Details

Critically ill adolescents are at greatest risk for developing hospital-acquired venous thromboembolism. To date, no phase 3 randomized controlled trials have been conducted for pharmacological thromboprophylaxis as primary venous thromboembolism prevention in children. The investigators will perform a United States definitive multicenter phase 3 randomized controlled trial of the low molecular weight heparin enoxaparin as primary venous thromboembolism prophylaxis among critically ill adolescents who are classified a priori as high risk based upon the investigators validated risk prediction models.

Key Dates

Start date
Apr 15, 2027
Status verified
May 2026
Primary completion
Apr 15, 2034
Completion
Apr 15, 2035

Study Design

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

Arms

  • Experimental: EnoxaparinThromboprophylaxis
    This arm will receive the study intervention, enoxaparin thromboprophylaxis during pediatric intensive care unit hospitalization
  • No Intervention: No Pharmacological Thromboprophylaxis
    This arm will receive no pharmacological thromboprophylaxis

Primary Outcome Measure

Risk (i.e., cumulative incidence) of Symptomatic venous thromboembolism [ Time Frame: From randomization through discharge from the pediatric intensive care unit, approximately 1-2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins All Children"s HospitalSt. PetersburgFlorida33704
Anthony A Sochet
[email protected]
727-767-2912
Anthony A Sochet, MD, MSc (PRINCIPAL_INVESTIGATOR)

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By research site
Johns Hopkins All Children"s Hospital· St. Petersburg, FL

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