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

May 21, 2026 updated by: Johns Hopkins All Children's Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This trial will establish definitive evidence on the comparative efficacy and safety of pharmacological thromboprophylaxis with the low molecular weight heparin (LMWH) enoxaparin versus no pharmacological thromboprophylaxis for the primary prevention of venous thromboembolism (VTE), including deep vein thrombosis and/or pulmonary embolism) among critically ill adolescents who meet a priori criteria for high risk of hospital-acquired (HA-) VTE. In the past two decades, the diagnosis of pediatric hospital-acquired VTE (HA-VTE) in the U.S. has increased 130-200-fold. The investigators have shown that critically-ill adolescents are one the highest risk subpopulations for HA-VTE, with average occurrence rates of 13.2% (range: 6.3-19.8%), and have derived and prospectively validated risk models for HA-VTE in this population. Despite a simultaneously increased risk of bleeding in critically ill adolescents, particularly after surgery or major trauma, an investigator-initiated multicenter phase 2 trial recently led by the investigators group during the COVID-19 pandemic demonstrated the safety of LMWH for primary HA-VTE prevention. To date, risk-stratified phase 3 Randomized Controlled Trials (RCTs) of LMWH thromboprophylaxis as primary HA-VTE prevention in children have not been performed. The investigators will perform a U.S.-based definitive multicenter phase 3 RCT of the LMWH enoxaparin versus no pharmacological thromboprophylaxis for VTE prevention among critically ill adolescents at highest a priori risk for HA-VTE applying evidence from the investigators published risk prediction models.

Study Type

Interventional

Enrollment (Estimated)

802

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Anthony A Sochet, MD, MSc
  • Phone Number: 727-767-2912
  • Email: sochet@jhmi.edu

Study Contact Backup

  • Name: Neil A Goldenberg, MD, Phd
  • Phone Number: 727-767-2912
  • Email: neil@jhmi.edu

Study Locations

  • United States
    • Florida
      • St. Petersburg, Florida, United States, 33704
        • Johns Hopkins All Children"s Hospital
        • Contact:
        • Principal Investigator:
          • Anthony A Sochet, MD, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Admission Age between 12- 18 years of age
  • Within 24 hours of pediatric intensive care unit (PICU) admission for enrollment
  • Presence of a Central Venous Catheter
  • Presumed or confirmed infection or systemic inflammatory condition

Exclusion Criteria:

  • Active treatment for VTE or known VTE present prior to or on pediatric intensive care unit (PICU) admission
  • Current receipt of an antithrombotic agent excluding unfractionated heparin for vascular catheter patency
  • Active ISTH-defined clinically relevant bleeding
  • Surgery in the last 7-days
  • Major trauma within the last 7-days
  • Admission for management of congenital heart disease including perioperative management of critical congenital heart disease
  • Presence of coagulopathy including:
  • International normalized ratio (INR) 2.0 activated partial thromboplastin time (aPTT) 50 seconds Platelet count 50 x103/mL
  • Creatinine clearance 30 ml/min/1.73 m2
  • Known hypersensitivity to heparin or pork products
  • Laboratory confirmed heparin induced thrombocytopenia
  • Current pregnancy or lactation,
  • Presence of an epidural catheter
  • Prior enrollment in the CRITICAL-Teens-TP Trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EnoxaparinThromboprophylaxis
This arm will receive the study intervention, enoxaparin thromboprophylaxis during pediatric intensive care unit hospitalization
Drug: Enoxaparin
Enoxaparin thromboprophylaxis administered subcutaneously twice daily (every 12 hours) from enrollment through pediatric intensive care unit discharge
No Intervention: No Pharmacological Thromboprophylaxis
This arm will receive no pharmacological thromboprophylaxis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
International Society on Thrombosis and Haemostasis (ISTH) defined symptomatic venous thromboembolism
From randomization through discharge from the pediatric intensive care unit, approximately 1-2 weeks
Risk (i.e., cumulative incidence) of Clinically relevant bleeding
Time Frame: From randomization through discharge from the pediatric intensive care unit, approximately 1-2 weeks
International Society on Thrombosis and Haemostasis (ISTH) defined clinically relevant bleeding (Major bleeding + Clinically relevant Non-major bleeding)
From randomization through discharge from the pediatric intensive care unit, approximately 1-2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk (i.e. cumulative incidence) of symptomatic venous thromboembolism
Time Frame: From randomization through 30-days post discharge from the pediatric intensive care unit
International Society on Thrombosis and Haemostasis-defined symptomatic venous thromboembolism
From randomization through 30-days post discharge from the pediatric intensive care unit
Risk (i.e. cumulative incidence) of clinically relevant bleeding
Time Frame: From randomization through 30-days post discharge from the pediatric intensive care unit
International Society on Thrombosis and Haemostasis-defined clinically relevant bleeding (Major Bleeding + Clinically Relevant Non-Major Bleeding)
From randomization through 30-days post discharge from the pediatric intensive care unit
Serious adverse events
Time Frame: From randomization through 30-days post discharge from the pediatric intensive care unit
As federally defined.
From randomization through 30-days post discharge from the pediatric intensive care unit
Net Clinical Benefit - Modelled Attributable Risk Difference in HA-VTE (Efficacy) by Attributable Risk Difference in clinically relevant bleeding (Safety)
Time Frame: From randomization through discharge from the pediatric intensive care unit, approximately 1-2 weeks
Net clinical benefit is a bivariate endpoint analysis (i.e., trade-off of venous thromboembolism and bleeding risks as described below). One-year risks and corresponding 95% confidence intervals (CI) of hospital-acquired venous thromboembolism and clinically relevant bleeding for each study arm will be calculated from weighted Kaplan-Meier curves. A bivariate decision curve will be specified using the 12-month absolute risk difference for venous thromboembolism and bleeding outcomes. Bivariate outcomes for enoxaparin and no pharmacological thromboprophylaxis will be compared under a hypothesis of superiority using the superiority boundary of a bivariate endpoint analysis, with inference based on the 95% confidence rectangle (i.e., the rectangle defined by the 95% CI for hospital-acquired venous thromboembolism absolute risk difference and the 95% CI for bleeding absolute risk difference). Superiority will be decided if the 95% confidence rectangle rules out the superiority curve.
From randomization through discharge from the pediatric intensive care unit, approximately 1-2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins All Children's Hospital

Collaborators

University of California, San Diego

Investigators

  • Principal Investigator: Anthony Sochet, MD, MSc, Johns Hopkins All Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2027

Primary Completion (Estimated)

April 15, 2034

Study Completion (Estimated)

April 15, 2035

Study Registration Dates

First Submitted

September 30, 2024

First Submitted That Met QC Criteria

October 3, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00507234-CRITICAL-Teens-TP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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