Cathflo Activase Pediatric Study

Inclusion criteria

Subjects had to meet the following inclusion criteria to be eligible for study entry:

• Less than 17 years of age
• Clinically stable
• Occlusion of CVAD (including catheters with valves, multiple lumens, umbilical catheters, and implanted ports)
• For subjects who weighed >= 10 kg, inability to withdraw 3 mL of blood from the CVAD
• For subjects who weighed < 10 kg, inability to withdraw 1 mL of blood from the CVAD
• Ability to infuse fluids at the volume necessary to instill Cathflo Activase into the CVAD
• Written informed consent and assent (if appropriate) provided by parent or legal guardian and compliance with study assessments for the full duration of the study

Exclusion criteria

• Ability to withdraw blood following subject repositioning
• CVAD insertion < 48 hours prior to enrollment
• Selected study catheter implanted specifically for hemodialysis
• Evidence of mechanical, non-thrombotic occlusion of the CVAD (e.g., kink in the CVAD or suture constricting the catheter)
• Previous enrollment in this study
• Use of fibrinolytic agent (e.g., alteplase, reteplase, tenecteplase, urokinase, streptokinase) within 24 hours of enrollment
• At high risk for bleeding events, embolic complications (i.e., recent pulmonary embolism, deep vein thrombosis, endarterectomy, clinically significant right-to-left shunt) in the opinion of the investigator, or with known condition for which bleeding constituted a significant hazard
• Known hypersensitivity to alteplase or any component of the formulation