FDA Approves Alteplase for Catheter Clearance

The U.S. Food and Drug Administration has approved Cathflo™ Activase® (Alteplase, Genentech, Inc.) for restoring the patency of catheters with thrombotic occlusions. Now available in a 2 mg vial, it is the only thrombolytic agent approved by the FDA for this indication since urokinase was taken off the market in late 1998.

Information about the research behind alteplase was published in the article, "Alteplase Safely Clears Thrombotic Catheter Occlusions," in the January/February LifelineLetter (available from the Oley office, or on-line at http://c4isr.com/oley/lifeline/altep.html).

Suggested procedures for treating a thrombotic catheter occlusion are reprinted from that article in the table below. The standard 2 mg dose of alteplase is used to fill the catheter, and then allowed to dwell in the catheter 30 to 120 minutes. A second dose can be tried if the first isn’t successful. If the catheter does not respond to two alteplase installations, or if dysfunction recurs, the clinician will need to further evaluate the nature of the occlusion. Occlusions may be caused by a number of factors other than a thrombus, such as lipid or drug precipitates, which would not be corrected by administering alteplase, and would therefore require a different type of treatment. (For more information on catheter occlusions and solutions, call the Oley office at 800/776-OLEY.) Finally, please note that the 20-30cc flush called for in the suggested procedure is likely too great a volume for a small child, and would need to be modified.

Suggested Procedure for Using Alteplase in Adults

Complete Occlusion
Clamp the catheter, remove the cap, and attach a
3-way stopcock to the catheter hub

Attach an alteplase-filled syringe to the stopcock port opposite the catheter hub and an empty 10-mL syringe to the side port; turn off the stopcock to the alteplase-filled syringe, which will open the stopcock to the empty syringe

Pull back on the empty-syringe plunger to the
8-mL mark, and while maintaining negative pressure, turn off the stopcock to the empty syringe, which will open the stopcock to the alteplase-filled syringe

Allow the alteplase solution to fill the lumen slowly; reclamp the catheter, remove the stopcock, and aseptically cap the hub

WAIT 30 minutes to 2 hours

Clamp the catheter and remove the cap

Attach an empty syringe to the external hub of the catheter, unclamp the catheter, and attempt to aspirate 5 mL of fluid

 

If able to aspirate fluid, clamp the catheter and attach a syringe filled with 0.9% NaCl; unclamp and flush the catheter with 20 to 30 mL using the push-pause method to increase turbulence within the fluid path. Clamp the catheter, remove the syringe, and resume therapy or lock the catheter

 

If unable to aspirate, instill a second dose of alteplase as described above. If the catheter remains occluded after 2 doses of alteplase, consider alternative etiologies, potential diagnostic approaches, and additional management strategies

 

Partial Occlusion

Clamp the catheter and remove the cap or IV tubing
Attach an alteplase-filled syringe to the external hub of the catheter, unclamp
the catheter, and slowly instill the alteplase solution to fill the lumen;
reclamp the catheter, remove the syringe, and aseptically cap the hub

WAIT 30 minutes to 2 hours

Clamp the catheter and remove the cap

Attach an empty syringe to the external hub of the catheter, unclamp the catheter, and attempt to aspirate 5 mL of fluid

 

If able to aspirate fluid, clamp the catheter and attach a syringe filled with 0.9% NaCl; unclamp and flush the catheter with 20 to 30 mL using the push-pause method to increase turbulence within the fluid path. Clamp the catheter, remove the syringe, and resume therapy or lock the catheter

 

If unable to aspirate, instill a second dose of alteplase as described above. If the catheter remains occluded after 2 doses of alteplase, consider alternative etiologies, potential diagnostic approaches, and additional management strategies