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Alteplase - Clearing Catheter Occlusions

Introduction:  I have been receiving repeated requests for information regarding alteplase and its use in catheter occlusions. I am including a general overview as well links to other sites that have published information in this area. If you currently have established guidelines you would like to post, please use the form at the bottom of this page.

Since the halting of the manufacture of urokinase by the FDA,  there has been additional focus on alternatives to be used for catheter clearance. The establishment  of appropriate guidelines, stability and batch processing in order to reduce costs have been examined. 

Because of the effectiveness of the 0.5 mg dose as an initial dose, this appears to be the best starting point when utilizing a stepped-dosage protocol for clearing catheter occlusions.  A study conducted at the University of Wisconsin Hospital and Clinics, which included patients with various degrees of catheter occlusion (from partial to complete occlusion) had found that 50 catheters in the study (86.2%) were cleared with alteplase 0.5 mg, 5 catheters (8.6%) were cleared with dose escalation to 1 mg and 1 catheter (1.7%) was cleared after dose escalation to 2 mg.1

Stability of batch processed syringes: 
The study at UWHC revealed the following:
Concentration Stability * Storage temp
1 & 2 mg/ml 14 days 2° Celsius
0.5 mg/ml 28 days 2° Celsius
The 0.5, 1, 2 mg/ml concentrations maintained adequate stability up to 28 days if stored for 14 days at -25 or -70°  Celsius, followed by 14 days at 2°  Celsius. 1


*Stability defined as the maintenance of sufficient antifibrinolytic activity at the end of the prescribed time.

Preparation:
Most protocols that have been established utilize the 50mg vial of alteplase. Once diluted, 2 mg of drug is  removed and placed into 5 ml syringes. Sterile water is then added to each syringe to bring the volume up to the desired level (usually 1 to 4 ml depending on the desired concentration: 0.5 to 2 mg/ml).  Average storage requirements are similar to the findings listed above. 

Utilization:
Thawing:  Once the syringes are thawed, they are stable for only 8 hours.  When clearing a catheter, an adequate amount of sodium chloride (preservative-free) must be added to sufficiently fill the catheter. I am including links to a few nursing sites below that describe the steps involved.  Initial doses on average range from 0.5 to 2 mg.    Dwell times range from 1 to 4 hours. In all cases, mechanical obstruction or pump failure needs to be ruled out.

References:
1.   Davis SN, Vermeulen L, Banton J, Schwartz BS, Williams EC. Activity and dosage of alteplase dilution for clearing occlusions of venous-access devices.
Am J Health Syst Pharm. 2000 Jun 1;57(11):1039-45.

2.  Hooke C. Recombinant tissue plasminogen activator for central venous access device occlusion. J Pediatr Oncol Nurs. 2000 Jul;17(3):174-8. Review.

3.  Wiernikowski JT, Crowther M, Clase CM, Ingram A, Andrew M, Chan AK. Stability and sterility of recombinant tissue plasminogen activator at -30 degrees Celsius. Lancet. 2000 Jun 24;355(9222):2221-2. 

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David F. McAuley, Pharm.D., R.Ph.  GlobalRPh Inc.
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