r fluid replacement, total parenteral nutrition, antibiotics, or other medications. Patients with hemodialysis catheters or known mechanical occlusions were excluded from the study, as were patients considered at high risk for bleeding or embolization. Patients were treated with up to two doses of Cathflo Activase instilled into the catheter lumen. For patients weighing ≥ 30 kg, the dose was 2 mg in 2 mL. For patients weighing < 30 kg, the dose was 110% of the estimated internal lumen volume, not to exceed 2 mg in 2 mL. Restoration of function was assessed at 30 and 120 minutes (if required) after administration of each dose. Restoration of function was defined as the ability to withdraw fluid (3 mL in patients ≥ 10 kg; 1 mL in patients < 10 kg) and infuse saline (5 mL in patients ≥ 10 kg; 3 mL in patients < 10 kg).
The overall rate of catheter function restoration of 83% (257 of 310) was similar to that observed in Trial 2, as were the rates of function restoration at the intermediate assessments.
The three trials had similar rates of catheter function restoration among the catheter types studied (single-, double-, and triple‑lumen, and implanted ports). No gender differences were observed in the rate of catheter function restoration. Results were similar across all age subgroups.
INDICATIONS AND USAGE
Cathflo® Activase® (Alteplase) is indicated for the restoration of function to central venous access devices as assessed by the ability to withdraw blood.
CONTRAINDICATIONS
Cathflo Activase should not be administered to patients with known hypersensitivity to Alteplase or any component of the formulation (see DESCRIPTION).
WARNINGS
None.
PRECAUTIONS
General
Catheter dysfunction may be caused by a variety of conditions other than thrombus formation, such as catheter malposition, mechanical failure, constriction by a suture, and lipid deposits or drug precipitates within the catheter lumen. These types of conditions should be considered before treatment with Cathflo Activase.
Because of the risk of damage to the vascular wall or collapse of soft‑walled catheters, vigorous suction should not be applied during attempts to determine catheter occlusion.
Excessive pressure should be avoided when Cathflo Activase is instilled into the catheter. Such force could cause rupture of the catheter or expulsion of the clot into the circulation.
Bleeding
The most frequent adverse reaction associated with all thrombolytics in all approved indications is bleeding (3,4). Cathflo Activase has not been studied in patients known to be at risk for bleeding events that may be associated with the use of thrombolytics. Caution should be exercised with patients who have active internal bleeding or who have had any of the following within 48 hours: surgery, obstetrical delivery, percutaneous biopsy of viscera or deep tissues, or puncture of non‑compressible vessels. In addition, caution should be exercised with patients who have thrombocytopenia, other hemostatic defects (including those secondary to severe hepatic or renal disease), or any condition for which bleeding constitutes a significant hazard or would be particularly difficult to manage because of its location, or who are at high risk for embolic complications (e.g., venous thrombosis in the region of the catheter). Death and permanent disability have been reported in patients who have experienced stroke and other serious bleeding episodes when receiving pharmacologic |
