Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628778
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Collaborative Risk-stratified Investigation in Teen Inpatients With Critical Illness Anticoagulation With LMWH in Kids for ThromboProphylaxis CRITICAL-Kids-TP
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Collaborative Risk-stratified Investigation in Teen Inpatients With Critical Illness Anticoagulation With LMWH in Kids for ThromboProphylaxis CRITICAL-Kids-TP
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRITICALKidsTP
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 andor 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 US 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 132 range 63-198 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 US-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None