Pediatric High-Risk Deep Venous Thrombosis Lytic Outcomes Trial — PHLO  

Deep Vein Thrombosis Clinical Trial

Official title: Pediatric High-Risk Deep Venous Thrombosis Lytic Outcomes Trial

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to determine if the use of adjunctive catheter-directed thrombolysis (CDT), which includes the intrathrombus administration of rt-PA (Activase/Alteplase), can prevent post-thrombotic syndrome (PTS) in pediatric patients with symptomatic proximal deep vein thrombosis (DVT) as compared with optimal standard anticoagulation alone.

Clinical Trial Description

rt-PA, the study drug, is a fibrinolytic drug that is indicated for use in acute myocardial infarction, acute ischemic stroke, and acute massive pulmonary embolism in adults. Previous studies have shown the ability of rt-PA to lyse venous thrombus in patients with deep vein thrombosis (DVT), and suggest that successful rt-PA mediated thrombolysis can prevent post-thrombotic syndrome (PTS).

rt-PA is delivered directly into venous thrombus using a catheter/device which is embedded within the thrombus by a physician under imaging guidance. This method of rt-PA delivery, catheter-directed thrombolysis (CDT), is thought to be safer, more effective, and more efficient than previous methods. The question of whether CDT using rt-PA improves long-term DVT patient outcomes with acceptable risk and cost is currently being studied in the ATTRACT Trial for adults, but has not yet been addressed in the pediatric population.

The rationale for performing the PHLO Trial is based upon:

• the major burden of PTS on pediatric DVT patients and the U.S. healthcare system

• the reported association between rapid clot lysis and prevention of PTS

• the proven ability of rt-PA to dissolve venous thrombus in proximal DVT

• the recent advances in CDT methods which may lower bleeding risk, but which could, inadvertently, cause more endothelial injury in the smaller caliber vessels of pediatric patients

• the lack of outcome evidence for either anticoagulation or catheter-directed thrombolysis in children

• the major clinical controversy on whether CDT should routinely be used for first-line DVT therapy ;

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Post-Thrombotic Syndrome
• Postphlebitic Syndrome
• Postthrombotic Syndrome
• Thrombosis
• Venous Thrombosis

• NCT number: NCT02767232
• Study type: Interventional
• Source: University of Colorado, Denver
• Status: Withdrawn
• Phase: Phase 3
• Start date: July 2018
• Completion date: June 2023