My patient. linetm. Help maintain quality care in the pediatric setting

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1 My patient My my linetm linetm Help maintain quality care in the pediatric setting

2 The role of central venous access devices in pediatric patients Central venous access devices (CVADs), also known as central venous catheters or central lines, have become essential in the management of children with acute and chronic diseases 1 CVADs are commonly placed in children with acute and chronic diseases requiring intravenous (IV) therapy 1-3 Pediatric catheter insertion sites In the pediatric patient, catheter type and location should be determined by 4 Age and size of the child Developmental considerations, such as level of activity and sense of body image Type and duration of therapy Vessel location is relatively similar in adults and children. Smaller body and vein size can make pediatric CVAD insertion more difficult. However, there are more potential site locations in young children, including the veins of the scalp and foot. 4 CVaD insertion and tip sites 4 TemporAl posterior AurICulAr Types of CVADs nontunneled catheters 5 Also called subclavian, percutaneous, acute-care, or short-term catheters Typically used for days or weeks for all types of IV therapy, to draw blood, and to monitor central venous pressure May be placed bedside or, if necessary, in an emergency setting without sedation peripherally inserted central catheters (piccs) 5 Often used when a catheter will be needed for less than 6 months or when access to the jugular or subclavian vein is unavailable Can be used for most IV therapies as well as for obtaining blood samples in a variety of care settings from diverse patient populations May be placed bedside or in an outpatient setting tunneled catheters 5,6 Designed for long-term use and frequent venous access Provide more reliable IV access for extended courses of antibiotics, chemotherapy, and parenteral nutrition Surgically inserted catheter management SuBClAVIAn CephAlIC BASIlIC BrAChIAl InTernAl jugular SuperIor VenA CAVA (TIp location) InFerIor VenA CAVA (AlTernATe TIp location) BrAChIAl implanted ports 5 Consist of 2 attached parts: the catheter and portal body with reservoir Long-term dwell capacity, requiring little maintenance when not in use Useful for cyclically infused therapies, such as chemotherapy, and blood draws may be done through the port Surgically inserted FemorAl 2 3

3 One in 4 catheters may become occluded 7* Occlusion is the most common noninfectious complication in the long-term use of CVaDs 8* Occlusions may occur in up to 25% of catheters7 May occur soon after insertion of a device or develop at any time during the course of IV therapy the majority of all occlusions approximately 58% are thrombotic 7* Thrombotic occlusions result from the formation of a thrombus within, surrounding, or at the tip of the catheter 9 Nonthrombotic occlusions may be caused by precipitates, malpositioning, mechanical obstructions, and other factors 9 Occlusions in pediatric CVaDs Due to smaller catheter sizes for pediatric patients, catheter occlusions may occur more frequently 4,10 Smaller PICCs (<3F) are more likely to fail than 3F to 5F PICCs 58% thrombotic 42% nonthrombotic Smaller vessels and slower rates of infusion lead to more frequent occlusion Nonthrombotic catheter occlusions Mechanical occlusions 9 Mechanical occlusions may result from malposition during insertion and use, or catheter migration Factors influencing the incidence of malposition include an increase in intrathoracic pressure from coughing, sneezing, or vomiting; arm movements; forceful flushing of the catheter; and thrombus formation Precipitates 9 Precipitates can form as a result of drug crystallization, drug-drug incompatibilities, or drug-solution incompatibilities Drug precipitates in the catheter may occur in conjunction with thrombus formation and should always be considered during assessment of an occlusion, since this may have implications for how the occlusion should be managed Lipid residue 9 Lipid residue can accumulate in central venous catheters, often following the administration of lipid-containing, three-in-one total parenteral nutrition admixtures or drugs with oleaginous vehicles Salvaging catheters with nonthrombotic occlusions 9 In many instances, mechanical problems, such as kinked tubing or clogged in-line filters, can be identified and corrected Possible interventions to reposition catheters include patient positioning, rapid flushing of the catheter guidewire catheter exchange, fluoroscopic catheter guidance, or partial catheter withdrawal Catheters occluded by calcium-phosphate precipitates can be treated with 0.1 N hydrochloric acid Sodium bicarbonate (1 meq/ml) is used for substances known to dissolve in an alkaline environment Lipid occlusions have been treated with ethanol (70%) or sodium hydroxide (0.1 mmol/ml) The use of incompatible drugs or solutions should be avoided *Data in this section derived from adult study populations. 4 5

4 Thrombotic catheter occlusions When introduced into the body, all catheters begin to accumulate fibrin. This is the body s natural attempt to protect itself against a foreign body. The fibrin starts to form a layer around the outside of the catheter within minutes of insertion, beginning at either the line entry site or where the tip contacts the vein. 2,11 Catheter occlusions can be partial or complete 5 5 Partial (or withdrawal): infusion is possible, but aspiration is not Complete: neither infusion nor aspiration is possible through the catheter 5 Partial occlusion Complete occlusion Intraluminal thrombus 12 Occurs when blood refluxes inside the catheter lumen Common causes of reflux include patient coughing, inadequate flushing after blood draws or after checking for blood return, or improper use of flush syringes Intraluminal thrombus (A) (B) Fibrin tail, or flap 12 Extends from the catheter tip but is drawn inward, blocking the opening of the catheter lumen on aspiration attempts Results in an ability to infuse fluids but inability to withdraw blood Mural thrombus 12,13 Forms where the catheter touches or rubs the vein wall Common sites are the entry site, anywhere along the catheter path, and the catheter tip Fibrin tail Penny Offer, CRNI Recovered triple-lumen catheter showing a fibrin tail (A). Penny Offer, CRNI Fibrin sheath encases catheter (B). Aspirating for positive blood return may reveal a partial occlusion Fibrin tail allowing infusion Beginning to flap back with start of withdrawal Blocking aspiration of the catheter Fibrin sheath 2,12 Forms when fibrin adheres to the external catheter surface, often beginning at the entry site, and may encase all or part of the catheter like a sock May completely cover the opening of the catheter tip Mural thrombus Penny Offer, CRNI Penny Offer, CRNI Penny Offer, CRNI Fibrin sheath Flushing the line is not enough you must be able to withdraw blood to rule out a partial occlusion before administering critical therapies

5 Catheters deliver life-sustaining therapies CVADs can be used for 1-3 Intermediate to long-term access (>7 days) Patients requiring parenteral nutrition and chemotherapy Administration of agents that would otherwise act as vesicants Administration of medications requiring maximum hemodilution Frequent blood sampling or infusion of blood products Patients with poor peripheral venous access Reliable access to venous circulation for home care Why is it important to ensure central line patency? 2 An occluded line may compromise patient care by Canceling or delaying procedures Interrupting administration of medications and solutions Replacement of an occluded line may2,8,14 Disrupt therapy Increase patient discomfort and trauma, risk of complications, and cost of care Satisfaction with infusion care is linked to a hospital s patient satisfaction scores. 15 Patients should be carefully assessed for indications of catheter-related thrombosis Clinical signs of a potential complication include 2,16,17 : Inability to aspirate blood Inability to flush without resistance Swelling around the insertion site Evidence of fluid leakage While it is important to carefully monitor manifestations of occlusion, up to 50% of pediatric patients with occluded central venous access devices are asymptomatic

6 Assessing and maintaining catheter patency in pediatric patients Recommended routine assessment of catheter patency 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. Infusion Nurses Society (INS) Standards of Practice, The nurse should assess for and identify signs of CVAD occlusion, including the inability to withdraw blood, sluggish flow, and/or inability to flush or infuse through the device. INS Standards of Practice, Assess patency before infusion Indications of a blockage 2,12 : Catheter patency should always be assessed prior to initiation of each infusion therapy17 Brisk, free-flowing blood return should be achievable and is effective through 3F PICCs in children18 Lack of free-flowing blood return, even if the line flushes easily Inability to infuse fluids Follow organizational policies and procedures for flushing 5,17 Ensure appropriate frequency and volume of flush for CVAD4,5,10,18 Smaller catheters require decreased volume of flush INS and ONS recommend using appropriate syringe size 5,17 Follow catheter manufacturer s instructions in selecting syringe size Do not forcefully flush; if resistance is noted, assess catheter patency Clinical personnel should document type, brand, length, and size of vascular catheter When infusing, a larger syringe should be used, as smaller syringes create more pressure ONS=Oncology Nursing Society. Increased resistance when flushing Sluggish flow* * According to the Oncology Nursing Advisory Board, sluggish flow is defined as blood return of <3 ml in 3 seconds. 19 Prior to the administration of any medications or solutions, the nurse should always: Aspirate for a positive blood return (the ability to withdraw blood at 3 ml in 3 seconds ) Check for other indications of a blockage (see previous page) Attempt to flush to determine resistance, flushing with an adequate volume of saline or appropriate solution Palpate the insertion site to determine tenderness Assess the patient for any pain or discomfort, and check for edema at the site Institutions should adopt standardized procedures to manage thrombotic occlusions. This includes educational and skilldevelopment needs of team members, followed by the design of appropriate educational materials and training. Oncology Nursing Advisory Board, As recommended by the INS and Oncology Nursing Advisory Board. According to the Oncology Nursing Advisory Board

7 Recommended algorithm for assessing and treating occluded catheters 8 Sluggish flow or inability to withdraw blood or infuse fluid through the catheter Cathflo Activase (alteplase) plays a key role in helping to restore function to catheters with thrombotic occlusions 5,8 Flow restored Check for presence of mechanical obstruction Suspect thrombotic occlusion Obstruction remains Cathflo, a recombinant form of t-pa, is the only lytic that is FDA approved for the restoration of function to CVADs 20 Function restored *Please refer to dosing chart on page 17. Instill appropriate dose of Cathflo based on patient weight* Function restored Obstruction remains Consult with medical team to consider alternative etiologies and additional management strategies Obstruction remains Repeat Cathflo dose Yes Administer appropriate p solvents per hospital protocol Obstruction remains Suspect nonthrombotic occlusion Flow restored No Adapted from McKnight S. Cathflo a fibrin-specific MOA The fibrin-specific mechanism of action of Cathflo addresses the root cause of thrombotic occlusions Cathflo binds to fibrin in the thrombus, converting entrapped plasminogen to plasmin, helping to break down existing thrombotic occlusions 20 Cathflo is recommended as the first step in treating partial or complete thrombotic occlusions, after ruling out mechanical obstruction, by clinical practice guidelines of the INS, the Association for Vascular Access, the Oncology Nursing Society, and other treatment algorithms 5,8,12,17,19 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. t-pa 1 t-pa Plasminogen Activation Thrombus Fibrin threads Plasmin 1 Recombinant t-pa (alteplase) binds to fibrin in thrombus 2 plasminogen to plasmin that 3 initiates local fibrinolysis. The clinical significance of fibrin specificity is unknown. 2 Dissolves fibrin 3 Fibrin degradation products converts entrapped product information 12 13

8 Cathflo Activase (alteplase) Pediatric Study (CAPS) 20,21 Cathflo efficacy and safety profile in pediatric patients Largest study of thrombolytic therapy in pediatric patients Designed to evaluate the safety profile of Cathflo in 310 pediatric patients 17 years of age and younger 55 patients <2 years of age The youngest patient was 2 weeks old Cathflo may restore catheter function CAPS (N=310): Clinical efficacy 20,21 54% Rapid restoration Cathflo restored function within 30 minutes in 54% (166/310) of central lines. The smallest patient weighed 2.2 kg Cathflo has a safety profile in pediatric patients as young as 2 weeks of age 20 Cathflo does not reach pharmacologic levels in systemic circulation20 CAPS (N=310): Serious adverse events 20 Event (%) Catheter-related complications 1.3%* Sepsis 1.0% 75% 83% First-dose efficacy Cathflo restored function after 1 dose in 75% (233/310) of central lines after up to 120 minutes of dwell time. Cumulative efficacy Cathflo restored function in 83% (257/310) of central lines after up to 2 doses using a 120-minute dwell time for each. Fever/lethargy <1.0% Intracranial hemorrhage 0.0% Major hemorrhage 0.0% Thrombosis 0.0% Embolic event 0.0% Adapted from Blaney M, et al. *At least 1 due to catheter rupture. No reports of intracranial hemorrhage or embolic events with Cathflo in clinical trials, even in infants as young as 2 weeks of age 20,21 The 2011 INS Standards of Practice state that the instillation of alteplase 2 mg is effective in restoring catheter patency in patients 18 A fibrinolytic is indicated for a thrombotic CVC occlusion and includes a complete occlusion, partial occlusion, and sluggish catheter. Pedivan Guidelines, CAPS was an open-label, single-arm trial that evaluated the safety of Cathflo in 310 patients between the ages of 2 weeks and 17 years. Secondary objectives included assessing restoration rates at 30 minutes and 120 minutes, and serious adverse events within 48 hours. Please see Indication and Important Safety Information on back cover. Please also see accompanying full Prescribing Information

9 Reconstitution, dosing, and administration with Cathflo Activase (alteplase) Cathflo is available in a single-use, 2-mg vial. 20 Preparation of solution 20 After WASHING hands using aseptic technique, reconstitute Cathflo to a final concentration of 2 mg/2 ml: Administration 20,23 After WASHING hands and applying gloves: Aseptically WITHDRAW 2.2 ml of Sterile Water for Injection, USP (diluent is not provided). Do not use Bacteriostatic Water for Injection, USP. INJECT the 2.2 ml of Sterile Water for Injection, USP, into the Cathflo vial, directing the diluent stream into the powder. Slight foaming is not unusual; let the vial stand undisturbed to allow large bubbles to dissipate. Mix by gently SWIRLING until the contents are completely dissolved. Complete dissolution should occur within 3 minutes. DO NOT SHAKE. The reconstituted preparation results in a colorless to pale yellow transparent solution at a ph of approximately 7.3. INSPECT the product prior to administration for foreign matter and discoloration. Solution should be inspected immediately before use. WITHDRAW 2 ml (2 mg) of reconstituted solution from the vial. SCRUB the hub. Apply vigorous friction to the hubs for 15 to 30 seconds. Please see Indication and Important Safety Information on back cover. Please also see accompanying full Prescribing Information. administration, cont d minutes 120 minutes Dosing with Cathflo 2 mg 20 patient weight instill the appropriate dose of Cathflo into the occluded catheter using an appropriately sized syringe (see dosing chart below). After 30 minutes of DWell time, assess the catheter function by attempting to aspirate blood. If the catheter is functional, go to step 10; if not functional, go to step 9. assess catheter function after a total of 120 minutes of dwell time by attempting to aspirate blood. If catheter is functional, go to step 10. If catheter is still occluded, a second dose of equal amount may be instilled. Repeat steps 1 through 8. If catheter function has been restored, aspirate 4 ml to 5 ml of blood in patients 10 kg or 3 ml in patients <10 kg to remove Cathflo and residual clot. Then gently irrigate the catheter with 0.9% Sodium Chloride, USP. any unused solution should be discarded. Cathflo dose <30 kg (66 lb) 110% of the internal lumen volume of CVaD, not to exceed 2 mg in 2 ml 30 kg (66 lb) 2 mg in 2 ml note: Store lyophilized Cathflo at refrigerated temperature (2 C-8 C/36 F-46 F). Cathflo should be reconstituted immediately before use. The solution may be used within 8 hours if stored at 2 C to 30 C (36 F-86 F). no other medication should be added to solutions containing Cathflo. If catheter function is not restored at 120 minutes after 1 dose of Cathflo, a second dose may be instilled Studies have not been performed with administration of total doses greater than 4 mg (two 2-mg doses) References: 1. Schilling S, Doellman D, Hutchinson N, Jacobs BR. The impact of needleless connector device design on central venous catheter occlusion in children: a prospective, controlled trial. J Parenter Enteral Nutr. 2006;30(2): Hadaway LC. Reopen the pipeline for IV therapy. Nursing. 2005;35(8): Harris JL, Maguire D. Developing a protocol to prevent and treat pediatric central venous catheter occlusions. J Intraven Nurs. 1999;22(4): Frey AM. Intravenous therapy in children. In: Hankins J, Lonsway RAW, Hedrick C, Perdue M, eds. Infusion Therapy in Clinical Practice. 2nd ed. Philadelphia, PA: WB Saunders; 2001: Camp-Sorrell D, ed. Access Device Guidelines: Recommendations for Nursing Practice and Education. 2nd ed. Pittsburgh, PA: Oncology Nursing Society; Richardson D. Vascular access nursing: standards of care, and strategies in the prevention of infection: a primer on central venous catheters (part 2 of a 3-part series). JAVA. 2007;12(1): 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): McKnight S. Nurse s guide to understanding and treating thrombotic occlusion of central venous access devices. Medsurg Nurs. 2004;13(6): National Institutes of Health. Management of central venous catheter occlusions. Pharm Update Nov/Dec: Thiagarajan RR, Bratton SL, Gettmann T, Ramamoorthy C. Efficacy of peripherally inserted central venous catheters placed in noncentral veins. Arch Pediatr Adolesc Med. 1998;152(5): Ryder M. The role of biofilm in vascular catheter-related infections. N Dev Vasc Dis. 2001;2: Haire WD, Herbst SF. Consensus conference on the use of alteplase (t-pa) for the management of thrombotic catheter dysfunction. J Vasc Access Devices. Summer 2000: Wingerter L. Vascular access device thrombosis. Clin J Oncol Nurs. 2003;7(3): Kokotis K. Cost containment and infusion services. J Infus Nurs. 2005;28(suppl 3):S22-S Harpel J. Best practices for vascular resource teams. J Infus Nurs. 2013;36(1): Infusion Nurses Society. Infusion nursing standards of practice. J Infus Nurs. 2011;34(suppl 1):S1-S Baskin JL, Pui C-H, Reiss U, et al. Management of occlusion and thrombosis associated with long-term indwelling central venous catheters. Lancet. 2009;374(9684): Knue M, Doellman D, Rabin K, Jacobs BR. The efficacy and safety of blood sampling through peripherally inserted central catheter devices in children. J Infus Nurs. 2005;28(1): Cummings-Winfield C, Mushani-Kanji T. Restoring patency to central venous access devices. Clin J Oncol Nurs. 2008;12(6): Cathflo Prescribing Information. Genentech USA, Inc. 21. Blaney M, Shen V, Kerner JA, et al; for 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(11 Pt 1): Doellman D, Pettit J, Catudal JP, et al. Best practice guidelines in the care and maintenance of pediatric central venous catheters. Pediatrics Vascular Access Network Web site. Accessed January 14, Kaler W, Chinn R. Successful disinfection of needleless access ports: a matter of time and friction. JAVA. 2007;12(3):

10 Don t let sluggish flow disrupt therapy Take charge with Cathflo Activase (alteplase) and help restore central line function Is there routine assessment of CVAD patency at your hospital? Ask your Genentech representative about resources to help you implement CVAD education and skill development 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. To learn more about the management of thrombotically occluded catheters, please visit or call Genentech Customer Service at to locate your local Genentech clinical specialist Genentech USA, Inc. All rights reserved. CAT/020215/0006 Printed in USA. Keep central lines open