Clinical Trial: Pediatric High-Risk Deep Venous Thrombosis Lytic Outcomes Trial

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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
    • Sponsor: University of Colorado, Denver

    Current Primary Outcome: Development of Post-Thrombotic Syndrome (PTS) [ Time Frame: within 24 months after randomization ]

    Post-thrombotic syndrome (PTS) as determined by the Manco-Johnson Pediatric PTS Instrument


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Change in Quality of Life (PedsQL) [ Time Frame: within 24 months of randomization ]
      Quality of life (QoL) as determined by the PedsQL(TM)
    • Change in Quality of Life (Peds-VEINES) [ Time Frame: within 24 months of randomization ]
      Quality of life (QoL) as determined by the Peds-VEINES-QoL
    • Assessment of Venous Valvular Reflux [ Time Frame: at 12 months post-diagnosis ]
      Venous reflux will be assessed in a subset of patients using standard techniques
    • Severity of Post-Thrombotic Syndrome (PTS) [ Time Frame: within 24 months of randomization ]
      Severity of PTS as determined by the Manco-Johnson PTS Instrument.
    • Time to Resolution of presenting Deep Vein Thrombosis (DVT) symptoms [ Time Frame: within 24 months of randomization ]
    • Degree of clot lysis [ Time Frame: within 24 months of randomization ]


    Original Secondary Outcome: Same as current

    Information By: University of Colorado, Denver

    Dates:
    Date Received: December 16, 2015
    Date Started: July 2017
    Date Completion: June 2022
    Last Updated: February 10, 2017
    Last Verified: February 2017