Established safety —
break down the clot with 2-mg Cathflo
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.
- Among 310 patients, 2 weeks through 16 years of age, including 55 patients less than 2 years old:
- Sepsis developed in 3 patients; each of these patients had evidence of infection prior to administration of Cathflo
- One of these patients developed fever and lethargy
- Four patients experienced catheter-related complications
- No pediatric patient experienced an intracranial hemorrhage, major hemorrhage, thrombosis, or embolic event
Adapted from Ponec et al and Deitcher et al.2,3
- In COOL-1 and COOL-2, the most serious adverse events reported were sepsis, major hemorrhage, gastrointestinal bleeding, and venous thrombosis
- In COOL-1 and COOL-2, there were no intracranial hemorrhages and no embolic events
Blaney M, Shen V, Kerner JA, 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.
Ponec D, Irwin D, Haire WD, Hill PA, Li X, McCluskey ER. 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.
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.
