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

Diagnostics and Clinical Support

Date of submission

January 2014

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 2015

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

guideline been peer reviewed by colleagues?

1b, 4

Evidence base: (1-5)

1a

meta analysis of randomised controlled trials

1b

at least one randomised controlled trial

2a

at least one well-designed controlled study without

randomisation
at least one other type of well-designed quasiexperimental study
well designed non-experimental descriptive studies
(ie comparative / correlation and case studies)
expert committee reports or opinions and / or clinical
experiences of respected authorities
recommended best practise based on the clinical
experience of the guideline developer

2b
3
4
5

Adult patients receiving rivaroxaban

requiring emergency surgery or treatment of
haemorrhage

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

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 dabigatran, 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 and rivaroxaban are new 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.
This guideline outlines the steps to be taken in patients who are taking rivaroxaban and require
an invasive procedure or who have bleeding complications.
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.
2
Rivaroxaban should be re-started post procedure when risk of bleeding is judged to be low.

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. 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 0844 892 0111 and
oncall haematologist via switchboard.

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 Xa

RAISED

INR (neoplastin) and / or 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

Discuss with surgeons and/or

haematologist post procedure
regarding restarting rivaroxaban

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

Recheck INR (neoplastin) and / or Xa

post administration and liaise with
haematology if activity still detected

Appendix 2 Patient Receiving Rivaroxaban (Xarelto) Therapy

Haemorrhage Protocol
STOP Rivaroxaban

Contact Haematologist
(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

Xa RAISED

INR (neoplastin) and / or

Xa NORMAL

Rivaroxaban effects may be

present

Minimal rivaroxaban effects

present. Employ standard
measures

Minor Bleed

Major Bleed

Life threatening haemorrhage

Maintain BP and Urine

Mechanical

compression
Delay next dose of
rivaroxaban or
discontinue

output
(Rivaroxaban is around
65% renally cleared)
Continues
to bleed

Continues
to bleed

Haemorrhage control measures

Consider tranexamic acid 1g IV

Recheck INR (neoplastin) and / or

Consider using IV Octaplex 25

Xa post administration, liaise with

haematology if activity still detected
Discuss with surgeons and/or
haematologist post procedure
regarding restarting rivaroxaban

units/Kg (up to a maximum of 3000

units) on advice of a haematologist
(obtain from blood bank)
Administration guidance available
in this guideline

Appendix 3
Effect of the new oral anticoagulants on coagulation screens
Apixaban, dabigatran and rivaroxaban are new 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)
Prolonged (in
linear fashion if
neoplastin used as
reagent)
Prolonged
(1.5-1.8 times
control)

PT

Prolonged

No effect

APTT

Prolonged

TT

No effect

Prolonged
(1.4-1.8 times
control) greatly
prolonged if
supratherapeutic
levels
Prolonged

Drug
Activity

Use anti Xa
assay

Platelet
count

No effect

Use Haemoclot
Use anti Xa assay
thrombin inhibitor
assay or ECT
No effect
No effect

D-dimer

Suppressed
levels

Suppressed
levels

Suppressed
levels

Fibrinogen

No effect

Can give falsely

low results

No effect

No effect

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

20.2.2013

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:

9.

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

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 February 2014