Collaborative Risk-stratified Investigation in Teen Inpatients With Critical Illness: Anticoagulation With LMWH in Kids for ThromboProphylaxis (CRITICAL-Kids-TP)

NCT ID: NCT06628778

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 802 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-10-31
• Study Completion Date: 2031-06-30

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 dalteparin 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.

Detailed Description

This trial will establish definitive evidence on the comparative efficacy and safety of pharmacological thromboprophylaxis with the low molecular weight heparin (LMWH) dalteparin versus standard of care (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. No anticoagulant has been FDA-approved for primary VTE prevention in hospitalized children. 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 dalteparin versus standard-of-care (SOC), 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.

Conditions

Venous Thromboembolism (VTE)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Dalteparin Thromboprophylaxis

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

Group Type: EXPERIMENTAL

Dalteparin

Intervention Type: DRUG

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

Standard-of-Care Arm

This arm will receive standard of care (i.e., no pharmacological thromboprophylaxis)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dalteparin

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

Intervention Type: DRUG

Eligibility Criteria

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
• Anticipated PICU Length of Stay /= 4 days
• Presumed or confirmed infection or 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-Kids-TP Trial

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: collaborator

Johns Hopkins All Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony Sochet, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins All Children's Hospital

Locations

Johns Hopkins All Children"s Hospital

St. Petersburg, Florida, United States

Countries

United States

Central Contacts

Anthony A Sochet, MD, MSc

Role: CONTACT

sochet@jhmi.edu

727-767-2912

Neil A Goldenberg, MD, Phd

Role: CONTACT

neil@jhmi.edu

727-767-2912

Facility Contacts

Anthony A Sochet

Role: primary

Sochet@jhmi.edu

727-767-2912

References

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. 2025 Nov 10;160:108142. doi: 10.1016/j.cct.2025.108142. Online ahead of print.

Reference Type: DERIVED

PMID: 41223938 (View on PubMed)

Other Identifiers

IRB00469377 - CRITICAL-Kids-TP

Identifier Type: -

Identifier Source: org_study_id