BEAUMONT HOSPITAL. Beaumont Hospital Department of Nephrology and Renal Nursing ADMINISTRATION OF ACTILYSE. Guideline Number: 13. Guideline Version: B

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2 BEAUMONT HOSPITAL Beaumont Hospital Department of Nephrology and Renal Nursing Guideline Name: GUIDELINES FOR THE ADMINISTRATION OF ACTILYSE Guideline Number: 13 Guideline Version: B Developed By: Betty McDonnell CMN 2 St. Martins Clare O Kane CNM 2 St. Martins. Approved By: Date Effective From: March 2009 Review Date: March 2011 Superseded Documents: 13a

3 Table of Contents 1. Aims/Purpose of guideline Review History Scope Guideline Definition Responsibilities Procedure Procedure for administration of Actilyse Procedure for administering Actilyse as a bolus injection Procedure for the infusion of Actilyse Distribution Filing Review Superseded / Obsolete Documents Reference List Appendices Appendix 1. Catheter Types and Priming Volumes Appendix 2. Actilyse Record Sheet

4 ACTILYSE (Alteplase INN ) Introduction This guideline on the management of occluded central venous access outlines how to determine if the central venous catheter is occluded, the procedure for administering actilyse, and lists the possible contra indication to the administration of actilyse. The aim of this guideline is to maximise the efficiency and safety in which actilyse is administered. Multidisciplinary care will be directed towards restoring the patency of the occluded central venous catheter.

5 1.0 Aim / Purpose of Guideline. To provide guidelines & assist the multidisciplinary team in restoring the patency of the occluded central venous catheter. 2.0 Review History Date Review No. Change Ref. Section March b Updated guideline 3.0 Scope This guideline applies to all staff working within the dialysis unit within Beaumont Hospital. It is intended as a guide towards best practice for all members of the multidisciplinary team involved in the care of the renal patient s occluded central venous catheter. 4.0 Guideline The objectives of this guideline are; To highlight the responsibilities and accountability of members of the multidisciplinary team involved managing the occluded central venous catheter. To ensure patient safety 5.0 Definitions. Actilyse is a fibrolinytic agent which helps break down blood clots. 6.0 Responsibilities The medical team must: Prescribe the administration of actilyse on the patients Drug Kardex, either bolus or infusion dosage. The Bolus actilyse prescription is valid for three administrations only and can only be administered by a renal dialysis trained nurse who fulfils the criteria. Further requirements of actilyse must be prescribed and Renal Nephrologist informed. An infusion of actilyse must be administered by the doctor. The Dialysis nurse must:

6 Be a registered General Nurse Intravenous training course completed Have one years haemodialysis experience Be deemed competent in the administration of actilyse by the CNM: Have completed the actilyse/tpa policy questionnaire. Have completed under observation one practical administration assessment. Adhere to the administration guidelines as detailed in 7.0 In accordance with the scope of Practice for Nursing and Midwifery (An Bord Altranais 2000) the nurse must accept accountability for her/his decisions and actions in the implementing of this Guideline.

7 7.0 Procedure 7.1: Procedure for administration of Actilyse. Actilyse vials should be kept in their original carton until preparation. Protect from light and do not store above 25 degrees centigrade. The reconstituted solution must be discarded immediately after use Determine the central venous catheter (CVC) is occluded: Absence of flow from the catheter lumen. Inability to aspirate heparin from the lumen. Blood flows generally <100ml/mn. Low arterial pressure of < -250 Venous pressure >250 ml/min at blood flow less than 200ml/min. Methods to restore catheter patency include: Change the patient s position Aspirate and administer normal saline flush through the line Assess hydration Screen the patient for possible contra-indications to Actilyse: Possible contra-indications where there is a high Risk of haemorrhage: Patients receiving oral anticoagulants History of nervous system damage Severe uncontrolled arterial hypertension. Bacterial endocarditis Acute pancreatitis In acute Myocardial infarction: History of stroke. In acute pulmonary embolism: History of stroke In acute Ischaemic stroke: Minor Neurological deficit. Seizure at onset of stroke Following two consecutive unsuccessful attempts to restore blood flow rates by administering actilyse as a bolus injection & in consultation with the nephrologist, actilyse should be administered by infusion. Actilyse infusion should take place in the renal day care ward or nephrology wards. Patients can be booked into the renal day care ward on ext 3144.

8 7.2 Procedure for administering Actilyse as a bolus injection under aseptic conditions. Check the actilyse prescription. Check the actilyse preparation with a second nurse or doctor. Under aseptic conditions, using sterile transfer device, add 10ml of sterile water to 10mg of Actilyse and agitate gently (1mg/ml). Do not shake. Remove the heparin from the lumens (If present). Flush arterial and venous lumens of the catheter with 10mls of 0.9% normal saline. Do not use Actilyse with Heparin. Catheter volumes vary in size. (Please refer to attached table, Appendix 1, for catheter volume.) Draw up volume of Actilyse equivalent to the volume of the arterial and venous lumen of the catheter, adding an extra 0.1ml/0.2ml as prescribed to ensure Actilyse reaches the tip of the catheter. Slowly and gently insert Actilyse to equal the volume of the catheter, exerting gentle pressure on syringe. Allow to dwell for one hour. Record details in patient s notes and prescription chart. (Actilyse record chart must be used for each dose of Actilyse Administered.) Monitor patient for possible adverse reactions, including minor bruising and bleeding. (See list in 7.1) After one hour, withdraw 5ml of blood. Flush catheter gently with normal saline. If blood flow is restored, resume haemodialysis if appropriate or aseptically insert heparin Lock and cap the catheter hub. Successful restoration of flow is determined by blood flow of at least 300ml/min and arterial pressure of >-200 If unsuccessful, a second dose may be given. Actilyse may be given post dialysis where partial flows only have been achieved but must be removed after one hour. Notify physician if attempts to restore patency are unsuccessful or if Actilyse cannot be removed from the line.

9 7.3 Procedure for the infusion of Actilyse under aseptic conditions. Check the actilyse prescription. Check the actilyse preparation with a second nurse or doctor. Under aseptic conditions, using sterile transfer device, add 10ml of sterile water to 10mg of Actilyse and agitate gently (1mg/ml). Do not shake. Remove the heparin from the lumens (If present). Flush arterial and venous lumens of the catheter with 10mls of 0.9% normal saline. Do not use Actilyse with Heparin. Draw up 2.5ml (2.5mg) of actilyse and infuse into a 50ml bag of normal saline. (Label for arterial port). Draw up 2.5ml (2.5mg) of actilyse and infuse into a 50ml bag of normal saline. (Label for venous port) Attach infusions to both arterial and venous ports under aseptic conditions and infuse at 17ml per hour for three hours via an infusomat. (Total dose of 5mg as per Study done in 2001) (J Vasc Interv Radiol 2001; 12: ). Record details in patient s notes and prescription chart. (Actilyse record chart must be used for each dose of Actilyse Administered.) Record baseline observations, observations at 15mins, then hourly as patients condition determines. Monitor patient for possible adverse reactions, including minor bruising and bleeding. o Hypersensitivity to the active substance or to any of the recipients. o Actilyse is contraindicated in cases where there is a high risk of haemorrhage such as: o Significant bleeding disorder at present or within the past 6 months o known haemorrhagic diathesis o Patients receiving oral anticoagulants, e.g. warfarin sodium o Manifest or recent severe or dangerous bleeding

10 o Known history of or suspected intracranial haemorrhage o Suspected subarachnoid haemorrhage or condition after subarachnoid haemorrhage from aneurysm o Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) o Recent (less than 10 days) traumatic external heart massage, obstetrical delivery, recent puncture of a non-compressible blood-vessel (e.g. subclavian or jugular vein puncture) o Severe uncontrolled arterial hypertension o Bacterial endocarditis, pericarditis o Acute pancreatitis o Documented ulcerative gastrointestinal disease during the last 3 months, oesophageal varices, arterial-aneurysm, arterial/venous malformations o Neoplasm with increased bleeding risk o Severe liver disease, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis o Major surgery or significant trauma in past 3 months. o Additional contraindications in acute myocardial infarction: any known history of haemorrhagic stroke or stroke of unknown origin, known history of ischaemic stroke or transient ischaemic attack (TIA) in the preceding 6 months, except current acute ischaemic stroke within 3 hours. ( After three hours, flush catheter ports gently with 10 ml normal saline. Aseptically insert heparin drawing up the volume equivalent to the volume of the arterial and Venous lumen of the catheter. Lock and cap the catheter hub. Successful restoration of flow is determined by blood flow of at least 300ml/min and arterial pressure of >-200 Inform the dialysis unit when completed Notify Nephrologist if attempts to restore patency are unsuccessful. The additional administration of actilyse by infusion will be as prescribed by the renal nephrologist according to the patient s current access.

11 8.0. Distribution A copy of the Guideline will be circulated to the relevant areas by the Divisional Nurse Manager. The clinical Nurse Manager in each area is responsible to ensure all staff access and read the Guideline. The Guideline will also be available on the nursing guideline page of the intranet. 9.0 Filing A copy will be filed in the policy and procedure book folder in each unit. The master copy will be filed in the Divisional Nurse Managers office Review This guideline will be reviewed in two years, March Superseded/ Obsolete Documents This is an updated version of the administration of Actilyse dated January 2006.

12 12.0 Reference List An Bord Altranais ( 2000) Scope of Nursing and Midwifery Practice Framework. Dublin. An Bord Altranais. Castner, D. (2001) The Efficacy of Reteplase in the treatment of Thrombosed Haemodialysis Venous Catheters: Nephrology Nursing Journal. Deitcher. S.R., Fesen M.R. Kiproff P.M.Hill.A, Xin L. McCluskey E.R., Semba.,C.P.(2001) Safety and Efficacy of Alteplase for Restoring Function in Occluded Central Venous Catheters: Results of the Cardiovascular Thrombolytic to open Occluded Lines Trial. Journal of Clinical Oncology, Vol 20, No1, 2002: Haire, W.D., Atkinson, J.B., Stephens, C.C. (1994) Urokinase Versus Recombinant Tissue Plasminogen Activator in Thrombosed Central Catheters: A Double Blinded Randomised Trial. Thrombosis and Haemostasis 72: Lam, X.M., Ward, C.A., Du Mee, C.P. (1995) Stability and Activity of Alteplase with Injectable Drugs Commonly used in Cardiac Therapy. Am J Health System Pharm Maloney, K.W., Hillery, C.A., Nelson, T.J., Gill, J.C. (1991) The use of Aliquoted and Frozen TPA IN Central Line Occlusions Blood. (supp) 25abstract National Kidney Foundation Dialysis Quality Initiative (1997) Clinical Practice Guidelines for Vascular Access. New York: National Kidney Foundation. Ponec, D., Irwin, D.,Haire WD, et al: (2001) Double-Blind placebo- controlled trial of recombinant tissue plasminogen activator for restoration of function in occluded central venous access devices: The Cardiovascular Thrombolytic to open occluded lines (COOL Efficacy Trial.) Journal of Vascular and Interventional Radiology 12: , Spry, L.A.., Miller, G. (2001) Low- dose TPA for Haemodialysis Catheter Clearance: Dialysis & Transplantation Volume 30, No.1.

13 Savader, S. J., Ehrman, K.O., Porter, D.J., Haikal, L.C. & Oteham, A.C. (2001) Treatment of haemodialysis catheter-associated fibrin sheaths by rt-pa infusion: critical analysis of 124 procedures. Journal of Vascular Intervention in Radiology Jun; 12(6): Appendices

14 Appendix 1. Catheter Types and Priming Volumes. Appendix 2. Actilyse Record Sheet. APPENDIX 1

15 CATHETER TYPES AND PRIMING VOLUMES CATHETER TYPE RECOMMENDED TYPE INSERTION LENGTH FRENCH SIZE PRIMING VOLUME A PRIMING VOLUME V CUFFED/ NON- CUFFED Gamcath GDC 1125 GDC 1120 Femoral Femoral 250 MM 250 MM 11F 11F 1.36 CC 1.2 CC 1.42 CC 1.26 CC Non-cuffed Non-cuffed VasCath Pre-curved CxC-3500 PC 12.5CM 10.8F 1.5 CC 1.2 CC Non-cuffed Medcomp (IJ) Pre-curved Duo flow XTP1141 JC XTP1161 JC XTP1181 JC Internal jugular Internal jugular Internal jugular 12 cm 15 cm 20 cm 11.5F 11.5F 11.5F 1.4cc 1.6cc 1.2cc 1.3cc Non-cuffed Non-cuffed Non-cuffed Triple lumen Gamcath GTC 1220 (Lt) Subclavian or Femoral 200 mm 12F 1.2cc 1.27cc Non-cuffed Mahurker Quinton Internal jugular Internal jugular Internal jugular Internal jugular 28cm 36cm 40cm 45cm 0.8cc 1.3cc 1.4cc 1.6cc 0.85cc 1.4cc 1.5cc 1.7cc Cuffed Cuffed Cuffed Cuffed Ash-Split ASPC 18P ASPC 24 ASPC 32 ASPC 40 Internal jugular Subclavian Femoral vein 18cm 24cm 32cm 40cm 10F 14F 14F 14F 1.75cc 1.85cc Cuffed Cuffed Cuffed Cuffed APPENDIX 2

16 Beaumont Hospital Renal Unit Actilyse Record Sheet Name:... Date of Birth:... Medical Record Number:... AFFIX HOSPITAL LABEL Prescription Date Date Administered Type of Catheter Dose Administered Indications For Use High Venous Resistance >250mmHg High Arterial Resistance>- 250mmHg BFR<250ml/min No Flow - Arterial Outcomes 5mls blood withdrawn Flow restored to 150 ml/min Flow restored to 250 ml/min or greater Flow restored on return to unit next treatment Venous or arterial resistance reduced No improvement; unable to complete treatment Other Given By