CLINICAL GUIDELINES ID TAG

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1 Title: Author: Speciality/ Division: Directorate: Date Uploaded: Review Date: September 2019 CG ID TAG CG0423 CLINICAL GUIDELINES ID TAG Clinical Guideline for Alteplase in intra-arterial thrombolysis for treating acute peripheral arterial occlusion Alaistair Lewis, Richard McConville, Joan Morton, Jayne Agnew Radiology/ Surgery Acute Version 1.0 September 2016 Page 1

2 Clinical Guideline for Alteplase in intra- arterial thrombolysis for treating acute peripheral arterial occlusion Thrombolytic therapy is used in the management of acute arterial ischaemia. The principle objective of thrombolytic therapy is to remove pathological thromboemboli and to facilitate restoration of vascular patency. Thrombolytic therapy is contraindicated in any patient with a high risk of haemorrhage. The Working Party on Thrombolysis in the Management of Limb Ischemia divided contraindications into absolute, major and minor (see table 1) Table 1 Contraindications to intra-arterial thrombolysis Absolute 1. Established cerebrovascular event (including TIAs within last 2 months) 2. Active bleeding diathesis 3. Recent gastrointestinal bleeding (<10 days) 4. Neurosurgery (intracranial, spinal) within last 3 months 5. Intracranial trauma within last 3 months Relative major 1. Cardiopulmonary resuscitation within last 10 days 2. Major nonvascular surgery or trauma within last 10 days 3. Uncontrolled hypertension >180 mm Hg systolic or >110 mm Hg DIASTOLIC 4. Puncture of noncompressible vessel 5. Intracranial tumour 6. Recent eye surgery Minor 1. Hepatic failure particularly those with coagulopathy 2. Bacterial endocarditis 3. Pregnancy 4. Diabetic haemorrhagic retinopathy The following conditions are also listed as contraindications to administration of alteplase by the manufacturer and should be evaluated on a case-by-case basis significant bleeding disorder at present or within the past 6 months known haemorrhagic diathesis patients receiving effective oral anticoagulant treatment, e.g. warfarin, apixaban manifest or recent severe or dangerous bleeding known history of or suspected intracranial haemorrhage suspected subarachnoid haemorrhage or condition after subarachnoid haemorrhage from aneurysm any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) recent (less than 10 days) traumatic external heart massage, obstetrical delivery, recent puncture of a noncompressible blood-vessel (e.g. subclavian or jugular vein puncture) severe uncontrolled arterial hypertension Version 1.0 September 2016 Page 2

3 bacterial endocarditis, pericarditis acute pancreatitis documented ulcerative gastrointestinal disease during the last 3 months, oesophageal varices, arterial-aneurysm, arterial/venous malformations neoplasm with increased bleeding risk severe liver disease, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis major surgery or significant trauma in past 3 months 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 platelet count of below 100,000/mm 3 This is an unlicensed use of alteplase. The patient s coagulation screen must be checked prior to the procedure. The PT should be within 9-13 seconds. If the result is outside this range the procedure is contraindicated. Following a diagnostic angiogram a sheath is inserted into the affected artery and a catheter inserted through the sheath with its tip positioned in close proximity to the thrombus, ideally within the thrombus if possible. This allows direct delivery of alteplase to the thrombus. A local hypercoagulable state may be present in the vessel undergoing thrombolysis. It is standard practice to concomitantly administer a low dose of unfractionated heparin to prevent immediate rethrombosis of the treated vessel and to prevent pericatheter thrombosis. The unfractionated heparin is infused via the sheath side arm with the aim of producing only mild prolongation of the APTT (NOT full anticoagulation). The radiologist/ surgeon must prescribe the intra-arterial alteplase and intra-arterial unfractionated heparin on the Trust Intra-arterial thrombolysis prescription chart. Radiology staff will initiate the alteplase and unfractionated heparin infusions and commence the intra-arterial thrombolysis monitoring sheet. Alteplase is administered via the intra-arterial catheter and unfractionated heparin via the sheath sidearm. Intra-arterial thrombolysis regime 1. Reconstitute the contents of a 20mg vial of alteplase with 20ml of water for injection to give a solution with a final concentration of 1mg/ml. This should be gently mixed and vigorous agitation or shaking should be avoided to prevent foam formation. 2. A loading dose of 2ml (2mg) of the reconstituted solution is administered by slow bolus injection into the arterial catheter by the interventional radiologist when the catheter is in position ml (10mg) of the reconstituted solution should be further diluted. Withdraw 10ml from a 50ml infusion bag of sodium chloride 0.9% and then add 10ml of the reconstituted alteplase. This gives a final concentration of 10mg in 50ml (1mg in 5ml). The infusion bag must be labelled and signed by two qualified practitioners. This solution has an expiry date of 8 hours at room temperature. (The remaining reconstituted alteplase solution should be discarded) Version 1.0 September 2016 Page 3

4 4. This solution is infused initially at 10ml per hour (2mg /hr) for two hours. Then it is infused as a maintenance infusion via the intra-arterial catheter at a rate of 5ml per hour (1mg/hr) thereafter. 5. For subsequent alteplase infusions reconstitute the contents of a 20mg vial of alteplase with 20ml of water for injection. The reconstituted solution is stable for 24 hours at 2-8 o C. Further dilute 10ml of the reconstituted solution. Remove 10ml from a 50ml infusion bag of sodium chloride 0.9% and then add 10ml of the reconstituted alteplase solution. This gives a final concentration of 10mg in 50ml (1mg in 5ml). This solution has an expiry date of 8 hours at room temperature. This solution should be infused at 5ml per hour (1mg/hr) until further radiology review (up to 24 hours). 6. Label the intra-arterial line 7. An intra-arterial thrombolysis monitoring sheet will be initiated in radiology and transferred back to the ward with the patient where ward nursing staff will continue to record the infusion rate and volume. Radiology staff will mark the position of the catheter in relation to the sheath to detect if line displacement occurs. If the position of the catheter moves more than 1cm, ward staff must contact the patient s consultant or radiologist immediately Unfractionated heparin 1. Unfractionated heparin is administered with alteplase to prevent re-occlusion after thrombolysis and should be given via the sheath side arm to reduce the risk of pericatheter thrombosis. 2. Draw up 25mls of 1,000 units per ml unfractionated heparin solution (25,000units). The syringe must be labelled and signed by two qualified practitioners. 3. Infuse the solution via the sheath side arm at a rate of 1mls per hour (1000 units/ hr). This infusion rate is NOT to be adjusted. There is no requirement for APTT monitoring with this regime. 4. An intra-arterial thrombolysis monitoring sheet will be initiated in radiology and transferred back to the ward with the patient where nursing staff must continue to record the infusion rate and volume. Duration of therapy The patient will return to radiology and undergo subsequent angiography within the next 24 hours in order to determine the effectiveness of thrombolysis. The decision to discontinue thrombolysis will be made by the radiologist based on angiography results. Nursing Observations and Patient Care Due to the increased risk of haemorrhage and shock during intra-arterial thrombolysis the patient should be strictly confined to bed rest and kept lying as flat as possible. Version 1.0 September 2016 Page 4

5 Intra-muscular injections should be avoided. Patient observations (blood pressure, heart rate, temperature, respiratory rate) should be recorded every 30 minutes for the first 2 hours and then every hour until thrombolysis is discontinued. A coagulation screen should be checked at 4 hours after commencing therapy, the purpose of which is to ensure hypersensitivity to heparin is not present. If the APPT is less than 45 seconds, the heparin infusion may continue without change. If the APPT is greater than 45 seconds, contact the named consultant directly for advice. The patient should be closely monitored for any signs of bleeding particularly at the arterial catheter site. Persistently low blood pressure and/or tachycardia may indicate haemorrhage and necessitates pausing the alteplase and unfractionated heparin infusions as soon as possible until this has been resolved. The catheter site should be monitored on an hourly basis and observations recorded on the intra-arterial thrombolysis monitoring sheet. Special consideration should be given to any bruising or hard swelling around the site which should be treated as haematoma by applying firm pressure and seeking medical advice. Once intra-arterial thrombolysis has been stopped the arterial catheter should be removed by radiology. The sheath should be removed by radiology following the angiogram. A sterile transparent dressing should then be placed over the site to allow observation and monitoring for haemorrhage and haematoma. These observations should continue every half hour to hourly for at least 4 hours and then 2 hourly after that and recorded on the thrombolysis monitoring sheet. References 1. Actilyse. Summary of Product Characteristics. Boehringer Ingelheim. Date of text revision 23 rd September Available at Accessed 26 th October Actilyse monograph Medusa Injectable Medicines Guide. Available at Accessed 26th October Working Party on Thrombolysis in the Management of Limb Ischemia. Thrombolysis in the Management of Lower Limb Peripheral Arterial Occlusion A Consensus Document. Journal of Vascular and Interventional Radiology 2003;7:S337-S349. Version 1.0 September 2016 Page 5

6 Intra-arterial thrombolysis prescription sheet Allergies/ Medicine sensitivities This section must be completed before prescribing and administration except in exceptional circumstances Medicine/allergen Date of Type of e.g. rash Signature/ designation/ date Write in CAPITAL LETTERS or use addressograph Patient s name: Health and Care no. Date of birth: or No known allergies (please tick) Signature/ Designation: Date: Hospital: Ward: Consultant: Initial prescription (radiology department use) Date Drug Route Rate Radiologist/surgeon Alteplase 2mg loading Via arterial Bolus dose Alteplase 10mg made up to 50ml with sodium chloride 0.9% (10mg in 50ml) Unfractionated heparin 25ml 1000units/ml catheter Via arterial catheter Via sheath side arm 10ml per hour for 2 hours 1ml per hour (1000 units/hr) Given by Witness Ongoing prescription (until further radiology review) Drug Alteplase 10mg Start date Rate Route 5ml per hour Arterial catheter Dilution Make up to 50ml with sodium chloride 0.9% Radiologist/ surgeon Date, time,, witness Date, time,, witness Date, time,, witness Pharmacy Drug Unfractionated heparin 25ml 1000units/ml Start date Pharmacy Additional comments Solution expires 8hrs after reconstitution Rate Route 1ml per hour Sheath side arm Dilution Radiologist/ surgeon Additional comments No requirement to monitor APTT Version 1.0 September 2016 Page 6

7 Allergies/ Medicine sensitivities This section must be completed before prescribing and administration except in exceptional circumstances Medicine/allergen Date of Intra-arterial thrombolysis monitoring sheet Type of e.g. rash Signature/ designation/ date Write in CAPITAL LETTERS or use addressograph Patient s name: Health and Care no. Date of birth: or No known allergies (please tick) Signature/ Designation: Date: Hospital: Ward: Consultant: Date of thrombolysis: Line labelled: Yes / No Date/ Time Alteplase Infusion rate Alteplase Infusion volume Heparin infusion rate Heparin infusion volume Line insertion site OK Position of catheter to sheath on insertion: Yes/No Line secure Limb check Pulse present Signature Print name Post removal check Date/ Time Insertion site checked Bleeding Signature Print name Version 1.0 September 2016 Page 7