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This was a Phase IV, open-label, single-arm, multicenter trial that was to be conducted at ~60 sites in the United States. Approximately 300 pediatric subjects with dysfunctional CVADs (including catheters with valves, multiple lumens, umbilical catheters, and implanted ports) were to be treated with up to two serially instilled doses of Cathflo Activase.
Condition or disease
Dysfunctional Central Venous Access Devices (CVADS)
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Ages Eligible for Study:
up to 17 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects had to meet the following inclusion criteria to be eligible for study entry:
Less than 17 years of age
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
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