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

NCT06628778 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: IRB00507234-CRITICAL-Teens-TP
• Study Type: interventional
• Target: 802
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Venous Thromboembolism (VTE)

Keywords

pediatric; adolescent; critical illness; thromboprophylaxis

Outcome Measures

Primary Outcomes (2)

• Risk (i.e., cumulative incidence) of Symptomatic venous thromboembolism

  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

  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 Outcomes (4)

• Net Clinical Benefit - Modelled Attributable Risk Difference in HA-VTE (Efficacy) by Attributable Risk Difference in clinically relevant bleeding (Safety)

  From randomization through discharge from the pediatric intensive care unit, approximately 1-2 weeks

• Risk (i.e. cumulative incidence) of 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

  From randomization through 30-days post discharge from the pediatric intensive care unit

• Serious adverse events

  From randomization through 30-days post discharge from the pediatric intensive care unit

Study Arms (2)

EnoxaparinThromboprophylaxis

EXPERIMENTAL

This arm will receive the study intervention, enoxaparin thromboprophylaxis during pediatric intensive care unit hospitalization

Drug: Enoxaparin

No Pharmacological Thromboprophylaxis

NO INTERVENTION

This arm will receive no pharmacological thromboprophylaxis

Interventions

Enoxaparin DRUG

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

EnoxaparinThromboprophylaxis

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins All Children's Hospital: lead
• University of California, San Diego: collaborator

Study Sites (1)

Johns Hopkins All Children"s Hospital

St. Petersburg, Florida, 33704, United States

Location

Related Publications (1)

• Sochet AA, Amankwah EK, Andalib V, Jaffray J, Male C, Faustino EV, Goldenberg NA; Pedi-ATLAS Group and the Antithrombotic Trials Working Party of the Pediatric Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Enhanced trial efficiency of the novel "contemporaneous control recapture" parallel-cohort RCT design: Methods and application in the CRITICAL-Kids-TP trial. Contemp Clin Trials. 2026 Jan;160:108142. doi: 10.1016/j.cct.2025.108142. Epub 2025 Nov 10.

  PMID: 41223938 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism; Critical Illness

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Anthony Sochet, MD, MSc

  Johns Hopkins All Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony A Sochet, MD, MSc

CONTACT

727-767-2912; sochet@jhmi.edu

Neil A Goldenberg, MD, Phd

CONTACT

727-767-2912; neil@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Prospective Randomized Open, Blinded-Endpoint study design. There will be a blinded end-point adjudication committee.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: PROBE study design, Randomized allocation 2:1 (Intervention:Standard of care) of enoxaparin thromboprophylaxis versus standard-of-care (i.e., no pharmacological thromboprophylaxis). Analytic study populations will be modified intent-to-treat, per-protocol, and safety populations

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 8, 2024
• Study Start (Estimated): April 15, 2027
• Primary Completion (Estimated): April 15, 2034
• Study Completion (Estimated): April 15, 2035
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)