Title of Guideline. Thrombosis Pharmacist)

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1 Title of Guideline Contact Name and Job Title (author) Guideline for patients receiving Rivaroxaban (Xarelto ) requiring Emergency Surgery or treatment for Haemorrhage Julian Holmes (Haemostasis and Thrombosis Pharmacist) Directorate & Speciality Cancer and associated specialities clinical haematology (haemostasis and thrombosis) Date of submission November 2015 Date on which guideline must be reviewed (this should be one to three years) Explicit definition of patient group to which it applies (e.g. inclusion and exclusion criteria, diagnosis) November 2017 Adult patients receiving rivaroxaban requiring emergency surgery or treatment of haemorrhage Abstract Key Words Statement of the evidence base of the guideline has the guideline been peer reviewed by colleagues? Evidence base: (1-5) 1a 1b meta analysis of randomised controlled trials at least one randomised controlled trial 2a at least one well-designed controlled study without randomisation 2b at least one other type of well-designed quasiexperimental study 3 well designed non-experimental descriptive studies (ie comparative / correlation and case studies) 4 expert committee reports or opinions and / or clinical experiences of respected authorities 5 recommended best practise based on the clinical experience of the guideline developer Consultation Process Target audience This guideline has been registered with the trust. However, clinical guidelines are guidelines only. The interpretation and application of clinical guidelines will remain the responsibility of the individual clinician. If in doubt contact a senior colleague or expert. Caution is advised when using guidelines after the review date. Contains information on the following: Measuring anticoagulant effect of rivaroxaban Withholding rivaroxaban for invasive procedures Reversal and overdose Emergency surgery and haemorrhage Rivaroxaban, emergency, surgery, atrial fibrillation, warfarin, haemorrhage, bleeding, octaplex, tranexamic acid 1b, 4 Based on the ROCKET-AF trial of warfarin vs rivaroxaban for SPAF NICE TA 256 April 2012 Northamptonshire prescribing advisory group (on behalf of East Midlands cardiac and stroke networks) SPC for rivaroxaban BCSH guideline Effect on routine coagulation screens and assessment of anticoagulation intensity in patient taking oral dabigatran or rivaroxaban Haemostasis and Thrombosis Service Drugs and Therapeutics Committee Anaesthetics All wards and clinical areas 1

2 Protocol for patients receiving Rivaroxaban (Xarelto ) requiring an invasive procedure, emergency surgery or treatment for haemorrhage Contents Criteria, Background, Measurement of effect of rivaroxaban, Invasive procedures and Elective surgery Page 2 Emergency surgery, reversal and overdose Page 3 Emergency surgery protocol Appendix 1 Haemorrhage Protocol Appendix 2 Effect of the new oral anticoagulants on coagulation screens Appendix 3 Equality impact assessment Page 7 Criteria Apixaban, dabigatran, rivaroxaban and edoxaban are direct oral anticoagulants that are alternatives to coumarins (e.g. warfarin) in selected groups of patients for certain indications. This guideline is for patients receiving rivaroxaban (Xarelto ) requiring an invasive procedure, emergency surgery or treatment for haemorrhage. For patients on apixaban (Eliquis ) or dabigatran (Pradaxa ) see alternative guidelines on the intranet. Background Rivaroxaban (Xarelto ) is a direct factor Xa inhibitor licensed to prevent stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation, or treatment of DVT and prevention of recurrence of DVT/PE. It is used in some patients unable to take warfarin. Further information can be found on the APC website and the Nottinghamshire Joint Formulary. Measurement of anti-coagulation effect of rivaroxaban Rivaroxaban does not routinely require monitoring of therapeutic response (unlike warfarin). However, if a patient has an episode of bleeding or requires an invasive procedure, measurement of an anticoagulant effect may be advantageous. A standard clotting screen has not been validated for assessing the degree of anticoagulation in a patient taking rivaroxaban and should not be used for this purpose. A prothombin time using a sensitive reagent such as neoplastin plus or a specific anti Xa can be used to measure the effect only after discussion with a haematologist. Appendix 3 shows the effect of all the new oral anticoagulants on clotting screens Invasive procedures and elective surgical interventions Stop rivaroxaban at least 24 hours before intervention. The bleeding risk for the procedure needs to be assessed by the clinician performing the procedure. The relevant bleeding risk vs thrombotic risk (with cessation of anticoagulation) needs to be assessed and discussed with the patient by the clinician performing the procedure. If procedure cannot be delayed until at least 24 hours post dose, the increased risk of bleeding should be assessed against the urgency of the intervention. This should be discussed with a haematologist. Rivaroxaban should be re-started post procedure when risk of bleeding is judged to be low. 2

3 Emergency surgery see Appendix 1 flowchart below Reversal or overdose There is no specific reversal agent and as yet there is no real evidence or experience on the reversal of rivaroxaban. *Octaplex has not been shown to reliably reverse the effects of rivaroxaban.if the patient has bleeding complications (related to overdose or otherwise) please see Appendix 2 flowchart. For overdoses contact the UK National Poisons Information Service on and oncall haematologist via switchboard. 3

4 Appendix 1 Patient Receiving Rivaroxaban (Xarelto ) Therapy Emergency Surgery Protocol STOP Rivaroxaban Contact Surgeon / Haematologist / Anaesthetist (If the patient presents within 1 hour of ingestion then consider using activated charcoal) Coagulation screen and additional tests as discussed with haematologists (Important to make a note of the timing of the last dose of rivaroxaban) FBC U&Es INR (neoplastin) and / or anti Xa RAISED INR (neoplastin) and / or anti Xa NORMAL Rivaroxaban effects may be present Minimal rivaroxaban effects present Maintain BP and Urine output (Rivaroxaban is around 65% renally cleared) Consult with the surgeons to consider delaying surgery if possible If surgery can be delayed for greater than 24 hours: omit dose of Rivaroxaban and proceed with surgery following discussion with surgeon and haematologist If immediate surgery is required: consider using IV Octaplex* 25 units/kg (up to a maximum of 3000 units) or an alternative prothrombin complex concentrate order via haematology registrar and obtain from blood bank. Administration guidance available in this guideline Discuss with surgeons and/or haematologist post procedure regarding restarting rivaroxaban Recheck INR (neoplastin) and / or anti Xa post administration and liaise with haematology if activity still detected 4

5 Appendix 2 Patient Receiving Rivaroxaban (Xarelto ) Therapy Haemorrhage Protocol STOP Rivaroxaban (If the patient presents within 1 hour of ingestion then consider using activated charcoal) Contact Haematologist Coagulation screen and additional tests as discussed with haematologists (Important to make a note of the timing of the last dose of rivaroxaban) FBC U&Es INR (neoplastin) and / or anti Xa RAISED INR (neoplastin) and / or anti Xa NORMAL Rivaroxaban effects may be present Minimal rivaroxaban effects present. Employ standard measures Minor Bleed Major Bleed Life threatening haemorrhage Mechanical compression Delay next dose of rivaroxaban or discontinue Continues to bleed Maintain BP and Urine output (Rivaroxaban is around 65% renally cleared) Haemorrhage control measures Consider tranexamic acid 1g IV Continues to bleed Recheck INR (neoplastin) and / or anti Xa post administration, liaise with haematology if activity still detected Discuss with surgeons and/or haematologist post procedure Consider using IV Octaplex* 25 units/kg (up to a maximum of 3000 units) on advice of a haematologist (obtain from blood bank) Administration guidance available in this guideline 5

6 Appendix 3 Effect of the new oral anticoagulants on coagulation screens Apixaban, dabigatran, rivaroxaban and edoxaban are direct oral anticoagulants that are alternatives to coumarins (e.g. warfarin) in selected groups of patients for certain indications. All these drugs accumulate in renal impairment. A standard clotting screen has not been validated for assessing the degree of anticoagulation in a patient taking these agents and should not be used for this purpose. Consult haematology for advice. The table below gives information on the drugs effects on coagulation screens: Parameter Apixaban Eliquis ) Dabigatran ( Pradaxa ) Rivaroxaban ( Xarelto ) Edoxaban (Lixiana ) PT Prolonged No effect Prolonged (in linear fashion if neoplastin used as reagent) Prolonged APTT Prolonged Prolonged ( times control) greatly prolonged if supratherapeutic levels Prolonged ( times control) Prolonged TT No effect Prolonged No effect No effect Drug Activity Use anti Xa assay Use Haemoclot thrombin inhibitor assay or ECT Use anti Xa assay Use anti Xa assay Platelet count No effect No effect No effect No effect D-dimer Suppressed levels Suppressed levels Suppressed levels Suppressed levels Fibrinogen No effect Can give falsely low results No effect No effect 6

7 Equality Impact Assessment Report 1. Name of Policy or Service Response to external best practice policy 2. Responsible Manager Owen Bennett (Clinical Quality, Risk and Safety Manager) 3. Name of person Completing EIA Julian Holmes 4. Date EIA Completed Description and Aims of Policy/Service Guideline for patients receiving Rivaroxaban (Xarelto ) requiring Emergency Surgery or treatment for Haemorrhage 6. Brief Summary of Research and Relevant Data NICE guideline, BCSH guideline, SPC for rivaroxaban 7. Methods and Outcome of Consultation N/A 8. Results of Initial Screening or Full Equality Impact Assessment: Equality Group Age Gender Race Sexual Orientation Religion or belief Disability Dignity and Human Rights Working Patterns Social Deprivation Assessment of Impact Some Jehovah witnesses may not accept Octaplex 9. Decisions and/or Recommendations (including supporting rationale) From the information contained in the procedure, and following the initial screening, it is my decision that a full assessment is not required at the present time. 10. Equality Action Plan (if required) N/A 11. Monitoring and Review Arrangements Review November