drugset / Trial / NCT02767232
Pediatric High-Risk Deep Venous Thrombosis Lytic Outcomes Trial
Phase 3
Withdrawn
University of Colorado, Denver
Genentech, Inc. · collabMid America Heart Institute · collabNational Heart, Lung, and Blood Institute (NHLBI) · collabRTI International · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2018-07
- Primary completion
- 2023-04
- Completion
- 2023-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alteplase | Protein / enzyme biologic | 0.01 mg/kg | Other |
| Subject | Alteplase | Protein / enzyme biologic | 1 mg | Other |
| Subject | Alteplase | Protein / enzyme biologic | 25 mg | Other |
| Subject | Alteplase | Protein / enzyme biologic | 35 mg | Other |