Pediatric High-Risk Deep Venous Thrombosis Lytic Outcomes Trial

• Status: Withdrawn
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborators: Genentech, Inc.; Mid America Heart Institute; National Heart, Lung, and Blood Institute (NHLBI); RTI International
• Treatments: Plasminogen; Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

• Subject and/or legal guardian has voluntarily provided signed informed consent.

• Subject is 6-21 years old with a minimum weight of 20 kg at the time of enrollment.

• Radiologically-confirmed, symptomatic proximal lower extremity DVT involving the inferior vena cava, iliac vein, and/or common femoral vein; DVT must be occlusive in at least one involved vein

• Life expectancy greater than or equal to 2 years.

Exclusion Criteria:

• Symptom duration > 14 days for DVT episode in affected leg

• Known history of a bleeding disorder

• Known history of heparin-induced thrombocytopenia (HIT)

• Prior established diagnosis of PTS in lower extremities

• Circulatory compromise necessitating surgery

• Pulmonary embolism with hemodynamic compromise or other acute illness precluding tolerance of catheter-directed therapy

• Severe hypersensitivity or allergy to Activase(R), iodinated contrast or planned treatment anticoagulant drug, except for mild-moderate contrast allergies for which steroid pre-treatment can be used.

• Inability to maintain hemoglobin <9.0 mg/dL, INR >1.7, or platelets <100,000/mL, using transfusion as indicated.

• Active or historic bleeding, vasculopathy, coagulopathy, invasive procedure or medical condition contraindicating thrombolysis or anticoagulation

• Previous thrombolysis within the last month

• Pregnant female or within 7 days of uncomplicated delivery

• Participation in another investigational study within the last month

• Life expectancy < 2 years or with chronic non-ambulatory status

• Inability to provide informed consent or to comply with study assessments