Proven efficacy —
break down the clot with 2-mg Cathflo
Study design: COOL-1, a multicenter, double-blind, placebo-controlled comparison of the rates of restoration of catheter function after treatment for 2 hours with either alteplase 2 mg in 2 mL or placebo (N=150).
- COOL-2 — 85% cumulative efficacy after up to 2 doses using a 2-hour dwell
Study design: COOL-2, an open-label, single-arm, multicenter trial in which 995 patients received treatment with up to 2 doses of Cathflo 2 mg using a 2-hour dwell.
Study design: CAPS, a prospective, multicenter, open-label, single-arm study where two maximum does of 2 mg of alteplase was performed in patients between the age of 2 weeks and 17 with occluded catheters (N=310).
Earlier intervention increases rate of restored catheter function3
Study design: COOL-2, an open-label, single-arm, multicenter trial in which 995 patients received treatment with up to 2 doses of Cathflo 2 mg using a 2-hour dwell.
- 91% functional restoration in CVADs obstructed less than 24 hours
- Restoration rates decreased with longer duration of occlusion
Indication
Cathflo Activase (Alteplase) is indicated for the restoration of function to central venous access devices (CVADs) as assessed by the ability to withdraw blood.
Safety Information
Cathflo Activase should not be administered to patients with known hypersensitivity to Alteplase or any component of the formulation.
In clinical trials, the most serious adverse events reported after treatment were sepsis, gastrointestinal bleeding, and venous thrombosis.
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Ponec D, Irwin D, Haire WD, et al. Recombinant tissue plasminogen activator (alteplase) for restoration of flow in occluded central venous access devices: a double-blind placebo-controlled trial-the Cardiovascular Thrombolytic to Open Occluded Lines (COOL) efficacy trial. J Vasc Interv Radiol. 2001;12:951-955.
Blaney M, Shen V, Kerner J, et al, for the CAPS Investigators. Alteplase for the treatment of central venous catheter occlusion in children: results of a prospective, open-label, single-arm study (the Cathflo Activase Pediatric Study). J Vasc Interv Radiol. 2006;17:1745-1751.
Deitcher SR, Fesen MR, Kiproff PM, et al, for the Cardiovascular Thrombolytic to Open Occluded Lines-2 Investigators. Safety and efficacy of alteplase for restoring function in occluded central venous catheters: results of the Cardiovascular Thrombolytic to Open Occluded Lines trial.
J Clin Oncol. 2002;20:317-324.
