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Cathflo Activase (alteplase) use is supported by professional guidelines The Joint Commission advocates implementing evidence-based medicine practices1 The practice of evidence-based medicine involves ongoing systematic review of best and most • current scientific research 2 — Multicenter randomized trials with stringent endpoints provide the highest level of evidence3 Guidelines support good catheter management, including catheter salvage and use of an approved thrombolytic agent Association/society Guidelines “The nurse should aspirate for a positive blood return from the vascular access device (VAD) to confirm device patency prior to administration of parenteral medications and solutions.”4 Infusion Nurses Society (INS) “The instillation of low-dose alteplase is effective in restoring blood flow....”4 “All infusion equipment and supplies shall be inspected for product integrity before, during, and after use. If a product’s integrity is compromised or the product is expired, it shall not be used.”4 Association for Vascular Access (AVA) “Catheter salvage is the preferred approach for managing thrombosed catheters….”5 “Published data have suggested that the instillation of very low-dose alteplase (recombinant t-PA) is…effective for the…restoration of function in the treatment of thrombotic catheter dysfunction.”5 The Society for Healthcare Epidemiology of America and the Infectious Diseases Society of America (SHEA/IDSA) “CVC insertion should be observed by a nurse, physician, or other healthcare personnel who has received appropriate education… to ensure that aseptic technique is maintained.”6 Oncology Nursing Society (ONS) “The use of alteplase for catheter occlusion has been found to be… [an] effective thrombolytic agent.”7 American Association of Critical-Care Nurses (AACN) “Currently, t-PA (alteplase, Cathflo Activase) is the only thrombolytic agent approved by the Food and Drug Administration for reestablishing patency in thrombosed central catheters.”8 The Centers for Disease Control and Prevention (CDC) “Do not routinely replace CVCs [or] PICCs [peripherally inserted central catheters]…to prevent catheter-related infections.”9 “Do not routinely replace CVCs [central venous catheters]….”6 Please see Indication and Important Safety Information on reverse side. www.cathflo.com Cathflo Activase (alteplase) is integral in evidence-based practices for treating thrombotically occluded catheters a common complication of central venous access devices (CVADs), can • Ccompromise atheter occlusion, patient care 10,11 each infusion, ensure catheter patency by assessing the catheter for a brisk, free-flowing • Pblood rior toreturn * 4,12 • U se of Cathflo to treat a thrombotic occlusion may restore function clinical trials, the most serious adverse events reported were sepsis, gastrointestinal • Ibleeding, n the Cathflo and venous thrombosis 13 13 *According to the Oncology Nursing Advisory Board, brisk, free-flowing blood return is defined as blood return of 3 mL in 3 seconds.12 Indication Cathflo Activase (alteplase) is indicated for the restoration of function to central venous access devices as assessed by the ability to withdraw blood. Important 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. Certain causes of catheter dysfunction should be considered before treatment with Cathflo Activase (ie, catheter malposition, mechanical failure, constriction by a suture and lipid deposits or drug precipitates within the catheter lumen). The most frequent adverse reaction associated with all thrombolytics in all approved indications is bleeding. Caution should be exercised with patients who have any condition for which bleeding constitutes a significant hazard. Cathflo Activase should be used with caution in the presence of known or suspected infection in the catheter. Please see accompanying full Prescribing Information for additional Important Safety Information. References: 1. Render ML, Brungs S, Kotagal U, et al. Evidence-based practice to reduce central line infections. Jt Comm J Qual Patient Saf. 2006;32(5):253-260. 2. Keckley PH. Evidence-based medicine in managed care: a survey of current and emerging strategies. MedGenMed. 2004;6(2):56. 3. Sackett DL. Rules of evidence and clinical recommendations on the use of antithrombotic agents. Chest. 1989;95(suppl 2):2S-4S. 4. Infusion Nurses Society. Infusion nursing standards of practice. J Infus Nurs. 2011;34(suppl 1):S1-S110. 5. Haire WD, Herbst SF. Highlights bulletin: consensus conference on the use of alteplase (t-PA) for the management of thrombotic catheter dysfunction. J Vasc Access Devices. Summer 2000:1-8. 6. Marschall J, Mermel LA, Classen D, et al. Strategies to prevent central line-associated bloodstream infections in acute care hospitals. Infect Control Hosp Epidemiol. 2008;29(suppl 1):S22-S30. 7. Camp-Sorrell D, ed. Access Device Guidelines: Recommendations for Nursing Practice and Education. 2nd ed. Pittsburgh, PA: Oncology Nursing Society; 2004. 8. Criddle LM. Ask the experts. Crit Care Nurse. 2007;27(3):78-81. 9. O’Grady NP, Alexander M, Burns LA, et al. Guidelines for the Prevention of Intravascular Catheter-related Infections, 2011. Centers for Disease Control and Prevention Web site. http://www.cdc.gov/hicpac/pdf/ guidelines/bsi-guidelines-2011.pdf. Accessed March 11, 2013. 10. McKnight S. Nurse’s guide to understanding and treating thrombotic occlusion of central venous access devices. Medsurg Nurs. 2004;13(6):377-382. 11. Stephens LC, Haire WD, Kotulak GD. Are clinical signs accurate indicators of the cause of central venous catheter occlusion? J Parenter Enteral Nutr. 1995;19(1):75-79. 12. Cummings-Winfield C, Mushani-Kanji T. Restoring patency to central venous access devices. Clin J Oncol Nurs. 2008;12(6):925-934. 13. Cathflo Prescribing Information. Genentech USA, Inc. www.cathflo.com © 2015 Genentech USA, Inc. All rights reserved. CAT/020915/0011 Printed in USA.