Title of Guideline Guideline for patients receiving Rivaroxaban
(Xarelto) requiring Emergency Surgery or
treatment for Haemorrhage
Contact Name and Job Title (author) Julian Holmes (Haemostasis and
Thrombosis Pharmacist)
Directorate & Speciality Cancer and associated specialitiesclinical
haematology (haemostasis and thrombosis)
Date of submission November 2015
Date on which guideline must be reviewed (this should be November 2017
one to three years)
Explicit definition of patient group to which it applies (e.g. Adult patients receiving rivaroxaban
inclusion and exclusion criteria, diagnosis) requiring emergency surgery or treatment of
haemorrhage
Abstract Contains information on the following:
Measuring anticoagulant effect of
rivaroxaban
Withholding rivaroxaban for invasive
procedures
Reversal and overdose
Emergency surgery and haemorrhage
Key Words Rivaroxaban, emergency, surgery, atrial
fibrillation, warfarin, haemorrhage, bleeding,
octaplex, tranexamic acid
Statement of the evidence base of the guideline has the 1b, 4
guideline been peer reviewed by colleagues?
Based on the ROCKET-AF trial of warfarin
Evidence base: (1-5) vs rivaroxaban for SPAF
1a meta analysis of randomised controlled trials NICE TA 256 April 2012
Northamptonshire prescribing advisory group
1b at least one randomised controlled trial (on behalf of East Midlands cardiac and stroke
networks)
2a at least one well-designed controlled study without
SPC for rivaroxaban
randomisation
BCSH guideline Effect on routine coagulation
2b at least one other type of well-designed quasi- screens and assessment of anticoagulation
experimental study intensity in patient taking oral dabigatran or
3 well designed non-experimental descriptive studies rivaroxaban
(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 Haemostasis and Thrombosis Service
Drugs and Therapeutics Committee
Anaesthetics
Target audience All wards and clinical areas
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.
1
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 Page 2
procedures and Elective surgery
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 www.nottsapc.nhs.uk 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
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 0344 892 0111 and
oncall haematologist via switchboard.
3
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 INR (neoplastin) and / or anti Xa
RAISED NORMAL
Rivaroxaban effects may be Minimal rivaroxaban effects
present 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 If immediate surgery is required:
greater than 24 hours: consider using IV Octaplex* 25 units/Kg
omit dose of Rivaroxaban (up to a maximum of 3000 units) or an
and proceed with surgery alternative prothrombin complex
following discussion with concentrate order via haematology
surgeon and haematologist registrar and obtain from blood bank.
Administration guidance available in this
guideline
Discuss with surgeons and/or Recheck INR (neoplastin) and / or anti
haematologist post procedure Xa post administration and liaise with
regarding restarting rivaroxaban haematology if activity still detected 4
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 INR (neoplastin) and / or
anti Xa RAISED anti Xa NORMAL
Rivaroxaban effects may be Minimal rivaroxaban effects
present present. Employ standard
measures
Minor Bleed Major Bleed Life threatening haemorrhage
Mechanical Maintain BP and Urine
compression output
Delay next dose of (Rivaroxaban is around
rivaroxaban or 65% renally cleared)
discontinue
Continues
to bleed
Continues Haemorrhage control measures
to bleed Consider tranexamic acid 1g IV
Recheck INR (neoplastin) and / or Consider using IV Octaplex* 25
anti Xa post administration, liaise units/Kg (up to a maximum of 3000
with haematology if activity still units) on advice of a haematologist
detected (obtain from blood bank)
Discuss with surgeons and/or Administration guidance available
haematologist post procedure in this guideline 5
Appendix 3
Effect of the new oral anticoagulants on coagulation screens
Apixaban, dabigatran, rivaroxaban and edoxaban are direct oral antico-
agulants 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 ad-
vice.
The table below gives information on the drugs effects on coagulation
screens:
Parameter Apixaban Dabigatran ( Rivaroxaban ( Edoxaban
Eliquis) Pradaxa) Xarelto) (Lixiana)
PT Prolonged No effect Prolonged (in linear Prolonged
fashion if neoplastin
used as reagent)
APTT Prolonged Prolonged Prolonged Prolonged
(1.4-1.8 times control) (1.5-1.8 times control)
greatly prolonged if
supratherapeutic levels
TT No effect Prolonged No effect No effect
Drug Use anti Xa assay Use Haemoclot Use anti Xa assay Use anti Xa assay
Activity thrombin inhibitor assay
or ECT
Platelet No effect No effect No effect No effect
count
D-dimer Suppressed levels Suppressed levels Suppressed Suppressed levels
levels
Fibrinogen No effect Can give falsely low No effect No effect
results
6
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
16.9.15
5. 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 Assessment of Impact
Age No Impact Identified
Gender No Impact Identified
Race No Impact Identified
Sexual Orientation No Impact Identified
Religion or belief Some Jehovah witnesses may not
accept Octaplex
Disability No Impact Identified
Dignity and Human Rights No Impact Identified
Working Patterns No Impact Identified
Social Deprivation No Impact Identified
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 2017 7
