Document name: Policy for Venous Thromboembolism prophylaxis in adult patients

Portfolio Medical Directorate

Document type: Medical Directorate

Staff group to whom itapplies:

All inpatient medical staff with responsibility for VTE risk assessment, prevention and treatment, whether in a permanent or temporary role

Distribution: All medical staff

How to access: Intranet

Issue date: March 2015

Version: 2

Next review: February 2017

Approved by: EMT

Developed by: Dr Adrian Berry & Dr Pravin Jha

Director leads: Medical Director

Contact for advice: Dr Pravin Jha

CONTENTS Abbreviations……………………………………………………………………...…..3

1. Introduction……………………………………………………………………….. …..4

2. Circulation……………………………………………………………………………...4

3. Scope …………………………………………………………………………………..4

4. Reason for development……………………………………………………………..5

5. Aims and objective……………………………………………………………………5

6. Definitions and abbreviations………………………………………………………..5

7. Process…………………………………………………………………………………6

8. Policy standards (Quality markers)………………………………………………….7

9. Responsibilities………………………………………………………………………..8

10. Training requirements………………………………………………………………...8

11. Monitoring and compliance of policy………………………………………………..9

12. Process for reviewing and approving policy…………………………………….…9

13. Dissemination, implementation and access of policy……………………………..9

Appendix 1: Risk assessment of VTE……………………………………………………..10

Appendix 2: Pharmacological methods of thromboprophylaxis……………………….12

Appendix 3: Mechanical methods of thromboprophylaxis……………………………..13

Appendix 4: Patient information leaflet…………………………………………………..14

Appendix 5: Audit tool……………………………………………………………………...17

Appendix 6: Barnsley Guideline for the Management of Bleeding with Newer Oral Anti-Coagulants ......………………………………………………………...18

Appendix 7: References…………………………………………………………………...19

Appendix 8: Equality impact assessment………………………………………….……..20

Appendix 9: Checklist for the Review and Approval of Procedural Document……....22

Appendix 10: Version Control Sheet………………………………………………………24

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A bb r e v i a t i o n s

BMI: body mass index

VTE: venous thromboembolism

DVT: deep vein thrombosis

PE: pulmonary embolism

INR: international normalised ratio

(standardised laboratory measure of blood coagulation)

LMWH: low molecular weight heparin

UFH: unfractionated heparin

Fondaparinux: fondaparinux sodium

HRT: hormone replacement therapy

Dabigatran: dabigatran etexilate

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1. Introduction

An estimated 25,000 people in the UK die from preventable hospital-acquired venous thromboembolism (VTE) every year1. Treatment of non-fatal symptomatic VTE and related long-term morbidities is associated with considerable cost to the health service.

VTE is a condition in which a blood clot (a thrombus) forms in a vein. It most commonly occurs in the deep veins of the legs; this is called deep vein thrombosis. The thrombus may dislodge from its site of origin to travel in the blood – a phenomenon called embolism.

VTE encompasses a range of clinical presentations. Venous thrombosis is often asymptomatic; less frequently it causes pain and swelling in the leg. Part or all of the thrombus can come free and travel to the lung as a potentially fatal pulmonary embolism. Symptomatic venous thrombosis carries a considerable burden of morbidity, sometimes over a long term because of chronic venous insufficiency. This in turn can cause venous ulceration and development of a post-thrombotic limb (characterised by chronic pain, swelling and skin changes).

The risk of developing VTE depends on the condition and/or procedure for which the patient is admitted and on any predisposing risk factors (such as age, obesity and concomitant conditions).

1House of Commons Health Committee (2005): The prevention of venous thromboembolism in hospitalised patients. London: The Stationery Office.2Academy of Medical Royal Colleges (2012): Prevention of venous thromboembolism

2. Circulation

This policy applies to all inpatient medical staff who will have the responsibility for VTE risk assessment, prevention and treatment, whether in a permanent or temporary role on behalf of SWYPFT.

3. Scope

This policy covers all adult patients (18 years and older) admitted to hospital as inpatients or formally admitted to a bed for day case procedures

Groups that will be covered:All in-patients and day patients under the care of SWYPFT

Patient Exclusions Patients of under 18 years of age Out Patients Patients admitted for treatment of VTE

4. Reason for development

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SWYPFT has a statutory obligation to patients to ensure compliance with NICE guidelines. SWYPFT makes Patient Safety a top priority

The purpose of this policy is to provide guidance to clinical staff on VTE prophylaxis to ensure compliance with NICE Clinical Guidance.

NICE recommends that all patients should be assessed to identify their risk factors for developing VTE.

VTE risk assessment is mandatory in the NHS operating framework 2012-13.

The policy was developed by Dr N Booya and Dr P Jha in consultation with: Medical staff across the Trust Pharmacy staff across the Trust In-patient nursing staff across the Trust ECT teams across the Trust

5. Aims and objectives

To identify all patients on admission who may be at risk of developing VTE.

To implement interventions to reduce the risk of VTE occurring during in-patient stay or any treatment that increases the risk.

To ensure a risk assessment is completed on admission of a patient to hospital and again after twenty-four hours for those identified as ‘at risk’.

To make explicit that prophylaxis must not be prescribed unless a valid and up to date VTE Risk assessment is completed.

Healthcare professionals will give At Risk patients verbal and written information about the risks of VTE and the effectiveness of prophylaxis.

To ensure VTE prophylaxis is documented in patients’ notes/care record in a standardised manner using a systematic approach across the Trust.

6. Definitions and abbreviations

6.1 Venous Thromboembolism (VTE):The formation of a blood clot (thrombus) in a vein which may dislodge from its site of origin to cause a pulmonary embolism

6.2 VTE prophylaxis:The active mechanism in reducing the risk of a VTE from occurring.

M e c han ic a l th r o m bop r o p h y l a x i s devices include graduated compression stockings, intermittent pneumatic compression and venous foot pumps. All increase venous outflow or reduce stasis within the leg veins.

Pharmacological th r ombop r o p h y l a xi s is pharmaceutical intervention to decrease the clotting ability of the blood. It includes Low molecular weight heparin and newer oral anticoagulants as Rivaroxaban and Dabigatran (as per locally agreed drug formulary)

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6.3 Significantly reduced mobilityBedbound, unable to walk unaided or likely to spend a substantial proportion of the day in bed or in a chair (NICE CG92).

6.4 Major bleeding:A bleeding event that results in one or more of the following;

Death A decrease in haemoglobin concentration of ≥2 g/dl Transfusion of ≥2 units of blood Bleeding into a retroperitoneal, intracranial or intraocular site A serious or life threatening clinical event A surgical or medical intervention

(NICE CG92)

7. Process

7.1 Risk Assessment7.1.1 All adult patients admitted to the Trust will be assessed for their VTE and

bleeding risk using the Trust VTE risk assessment tool (see appendix 1). 7.1.2 The risk assessment will take place on admission 7.1.3 VTE and bleeding risk assessment should be carried out by the admitting doctor

on the risk assessment proforma.7.1.4 Patients ‘at risk’ of VTE should be re-assessed within 24 hours of admission or if

clinical situation changes.7.1.5 Patient undergoing a course of ECT will have their VTE risk assessment

completed as part of the ECT preparatory process.7.1.6 Rationale for any deviation from NICE / Trust guidelines must be clearly

explained to the patient and fully documented in their medical record.

7.2 Prophylactic treatment7.2.1 All patients assessed to be at risk of VTE must be offered thromboprophylaxis

that is consistent with NICE and Trust guidelines unless contraindicated.7.2.2 Contraindications to pharmacological or mechanical prophylaxis must be clearly

documented in the patient’s medical record.7.2.3 Treatment must continue until discharge or until the patient no longer has

significantly reduced mobility (usually at least 5 – 7 days)7.2.4 Extended chemical thromboprophylaxis (appendix 2) must be prescribed for the

following high risk groups unless there are clearly documented contraindications (as per locally agreed protocol): Total hip replacement (35 days) Total knee replacement (14 days) Hip fracture (35 days) Major pelvic or abdominal surgery for cancer ( 28 days) ‘At risk’ Day Surgical Patients (5-7 days) ‘At risk’ patients in a lower limb plaster cast (consider prescribing prophylaxis

for the duration of plaster cast)

7.2.5 ‘At risk’ patients contraindicated for pharmacological prophylaxis must have anti-embolism stockings fitted on admission unless contraindicated. Stockings must be fitted and monitored in accordance with NICE guidance (appendix 3)

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7.2.6 All patients should be adequately hydrated according to their clinical condition.7.2.7 All patients should be mobilised as early as possible within the limitations of their

clinical condition.7.2.8 Patients diagnosed with a DVT or PE should be treated in accordance with the

locally agreed treatment guidelines.

7.3 Advice7.3.1. ‘At risk’ patients and their carers must be given written and verbal information on

VTE on admission and as part of the discharge process. Information should include the risk of VTE, methods of prevention and signs and symptoms of DVT and PE. This information is contained in the Trust patient information leaflet: “Venous thromboembolism” (appendix 4).

7.3.2 There must be clearly documented evidence in the ‘at risk’ patient’s medical record that patient information leaflet “Venous thromboembolism” has been provided.

7.4 If a DVT or PE is suspected7.4.1 Any suspicion of DVT or PE should be considered as a medical emergency.7.4.2 Immediate medical help should be requested from a local DGH on-call medical

team. 7.4.3 A treatment dose of heparin (or analogue) must be commenced immediately

unless contraindicated as per locally agreed guideline.

7.5 Confirmed DVT and PE 7.5.1 Confirmed cases of DVT and PE must be managed according to the locally

agreed Guideline.7.5.2 All cases of DVT or PE confirmed either radiologically or on post mortem must

be recorded on DATIX and processed by the Patient Safety Team as a serious incident (SI).

8. Policy Standards (Quality markers)

1. All patients, on admission, receive an assessment of VTE and bleeding risk using the clinical risk assessment criteria (appendix 1)

2. ‘At risk’ patients and their carer’s are offered verbal and written information on VTE prevention as part of the admission process

3. Patients provided with anti-embolism stockings have them fitted and monitored in accordance with NICE guidance (appendix 3)

4. Patients ‘at risk’ are re-assessed within 24 hours of admission for risk of VTE and bleeding

5. Patients assessed to be at risk of VTE are offered VTE prophylaxis in accordance with NICE guidance.

6. Patients/carers are offered verbal and written information on VTE prevention as part of the discharge process.

7. Patients are offered extended (post hospital) VTE prophylaxis in accordance with NICE guidance.

9. Responsibilities

9.1 Individual responsibilities

9.1.1 Chief Executive7

The chief Executive retains overall accountability for policies within the trust. Operational responsibility for this policy is delegated to the Trust Medical Director.

9.1.2 Executive management teamTo provide policy approval and ratification.

9.1.3 Trust Medical Director and Nursing DirectorThey are accountable for cascading this policy to all relevant clinical staff.

9.1.4 Director of Business delivery UnitAll district directors are accountable for cascading this policy to relevant clinical and managerial staffs to ensure implementation including meeting and training needs.

9.1.5 Consultant in-chargeThe admitting consultant is responsible for ensuring compliance with this policy for their patients. Consultant in-charge is responsible for ensuring that all middle grade and trainee doctors on their team have clear expectation clarity with regard to VTE Risk assessment and prophylaxis. Any training needs identified is actioned.

9.1.6 Admitting doctorThe admitting doctor is accountable and responsible for risk assessing patients admitted into hospitals and to undertake review. The admitting doctor will be responsible for prescribing relevant prophylaxis where applicable.

9.1.6 NursesNurses have a responsibility for promoting patient safety and are responsible for bringing this to the attention of admitting doctor. Ward/service Managers must ensure that nurses receive appropriate training and education in order to deliver on their responsibilities.

10. Training Requirements

Medical StaffAll junior medical staff and Barnsley SAS doctors must undertake VTE training as part of their induction and every two years thereafter (eLearning module or face-to-face).

11. Monitoring and Compliance of Policy Annual audit of implementation of VTE prophylaxis policy will be included in the

trust’s annual audit plan (appendix 5). Trust to meet any national requirement for collection of VTE risk assessment data.

12. Process for Reviewing and Approving this PolicyThis policy will be reviewed biennially or whenever national policy or guideline changes are required to be considered (whichever occurs first), primarily by the lead Director but in consultation with appropriate Trust groups. Following which it will be subject to approval by the appropriate Trust groups, currently the Executive Management Team.

13. Dissemination, implementation and access to this Policy

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This policy will be implemented and disseminated throughout the organisation immediately following approval and will be published on the Trust’s intranet site, including the medics intranet pages. It will also be included in the trainee doctor’s induction and induction pack. All staff will be alerted to changes to the policy through the Trust’s management briefing process.

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Appendix 1: RISK ASSESSMENT FOR VENOUS THROMBOEMBOLISM (VTE)

Admitting doctor should complete this form fully. After assessment, he/she should sign and file into the clinical record. Appropriate prophylaxis should be prescribed on the drug chart.

Patient’s name:

Ward:

Date of admission:

Date & Time of assessment:

Hospital number:

NHS number:

Consultant’s name:

Date of birth & age:

PROTOCOL

ALL adult patients (age above 18 years), on admission to the hospital, MUST be assessed for their risk of developing Venous Thromboembolism (VTE) and be prescribed appropriate thromboprophylaxis.

Patients ‘at risk’ should be reassessed within 24 hours of admission and whenever the clinical situation changes.

Tick boxes which apply –

Patient expected to have ongoing reduced mobility relative to normal state

Assess for VTE and bleeding risk below Presence of any risk factor of VTE should prompt thromboprophylaxis

Patient NOT expected to have significantly reduced mobility relative to normal state

Risk assessment complete (thromboprophylaxis not usually required)

Balance risks of VTE and bleeding. Do not offer pharmacological prophylaxis if patient has any risk factor for bleeding (Table 2) and risk of bleeding outweighs risk of VTE.

Maximum duration of LMWH use under license is 14 days. Use clinical judgment in initiating or continuing or stopping prophylaxis depending on potential for further improvement. eg :Non weight bearing patients due to fracture etc.

Specific contraindication: ‘Permanent’ significantly reduced mobility, on End of life carepathway, Warfarin treatment with INR >2. Increased risk of self harm is a relative contraindication.

Notes for discharge to other healthcare team1. Ensure patient/carer has received ‘Venous thromboembolism’ patient information leaflet2. Include the necessary information in verbal transfer/handover prior to transfer3. Clearly document the duration of treatment and the next proposed date for reassessment of risk

within the patient record.Definition: (NICE CG92)Significantly reduced mobility: bedbound, unable to walk unaided or likely to spend a substantial proportion of the day in bed or in a chair.Major bleeding: a bleeding event that results in one or more of the following: – death– a decrease in haemoglobin concentration of ≥ 2 g/dl – transfusion of ≥ 2 units of blood– bleeding into a retroperitoneal, intracranial or intraocular site– a serious or life-threatening clinical event– a surgical or medical intervention

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RISK ASSESSMENT

Table 1: Assess for risk factors for VTERisk factor √ Risk factor √Age >60 years Acute exacerbation of heart failureSignificantly reduced mobility for ≥ 3days Recent MI or recent (non-acute) strokeDehydration Pregnant or less than 6 weeks postpartumImmobility (plaster, paralysis, spinal surgery, hip or knee replacement surgery)

Varicose veins with phlebitis

Personal or first degree relative with a history of VTE Inflammatory bowel diseaseObesity with BMI >30 Nephrotic syndromeHormone therapy (Oestrogen containing OCP or HRT) Paraproteinuria, myeloproliferative

diseaseKnown Thrombophilia Acute or Chronic respiratory diseaseSepsis or Acute inflammatory disorder Any recent major surgery or any surgical

procedure lasting longer than 30 minutes Active cancer or cancer treatment Travel >3 hours within 4 weeks of Surgery

Table 2: Assess for risk factors for bleeding Active bleeding or high risk of bleedingeg Pericarditis, acute stroke (duration < 2 weeks), suspected bleeding aortic aneurysm, severe liver disease (prothrombin time above normal or known varices), brain tumour, intraocular surgery, head injury.

Lumbar puncture/epidural/spinal anaesthesia within the previous 4 hours or expected within the next 12 hours

Untreated inherited bleeding disorders (such as haemophilia and von Willebrand’s disease)

Platelet count less than 75 x 109 / L Severe renal disease (eGFR <15)On Warfarin with INR > 2 or taking Newer Oral anti-Coagulant (NOAC)

Previous Heparin inducedthrombocytopaenia or allergy toEnoxaparin or other HeparinsUncontrolled hypertension (Blood pressure greater

than or equal to > 230 mmHg systolic or 120 mmHg diastolic)

ACTION TAKEN (For full advice follow trust policy)No VTE risk factors present and hence no prophylaxis neededVTE risk factor(s) present and prophylaxis prescribed- ………………..………………………………………………...…VTE risk factor(s) present but no prophylaxis prescribed: Reason - ...……………………………………………..……..

PRESCRIPTION GUIDELINEGeneral Measures: Adequate hydration, early mobilisation and provide patient information leaflet Check Platelet count, Creatinine level (or eGFR) within 24 hours of admission and recheck once a week for initial 3

weeks if initiated on LMWH If there is a contraindication to LMWH, consider alternative option as pressure stocking (follow trust policy) If platelet count falls by >50% or symptoms of VTE develop, contact on-call medical team for advice

LMWH (Dalteparin) prescription guideline (if no contraindication): under 50kg: 2500 units once daily 50-90kg: 5000 units once daily 91-130kg: 7500 units once daily 131-170kg: 5000 units twice daily 171kg or over: 75 units/kg day in 2 divided doses (rounded to the nearest whole syringe)

Monitoring requirement:

Risk assessment and clinical monitoring are the best predictors of the risk of potential bleeding.

Check platelet count within 24 hours of initiation of therapy and then once a week for initial 3 weeks

Risk assessment completed by (name & signature): …………..…………………………..…………………………

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Appendix 2

Pharmacological methods of thromboprophylaxis

1. Low Molecular Weight Heparin (LMWH)

The trust’s Low Molecular Weight Heparins of choice is Dalteparin LMWH must be started as soon as possible after the risk assessment has been completed and

continue until the patient is no longer at increased risk of VTE. For prescribing information see BNF and summary of Product Characteristics (SPC).

http://www.medicines.org.uk/emc/medicine/26896/SPC/Fragmin+5000+IU Low molecular weight Heparin in contraindicated in patients with a history of Heparin-induced

thrombocytopenia (HIT). Low Molecular Weight Heparin is only licensed to be given in abdomen or thigh and therefore

should not be given in any other site.

2. Unfractionated Heparin (UFH) UFH is infrequently used and the standard dose for VTE prophylaxis is 5000 IU every 8-12 hours

daily When estimated GFR is <30ml/min, lower dose 5,000 IU 12-24 hours daily should be used or

LMWH should be prescribed. Unfractionated Heparin in contraindicated in patients with a history of Heparin-induced

thrombocytopenia (HIT). For prescribing information see BNF and summary of Product Characteristics (SPC).

http://www.medicines.org.uk/EMC/medicine/9789/SPC/Heparin+sodium+5%2c000+I.U.+ml+solution+for+injection+or+concentrate+for+solution+for+infusion+(with+preservative)/

3. Newer oral anti-coagulants (Rivaroxaban, Dabigatran, Apixaban)

These oral anti-coagulants should only be prescribed after discussing with on-call medical Consultant (follow local guideline). For the management of newer oral anticoagulant induced bleeding, follow the Barnsley protocol (appendix 6).

4. Important exceptions and considerations

Some patients will be taking oral anticoagulants (usually warfarin) prior to admission. All such patients admitted routinely should have a plan for management of anticoagulation. If warfarin is continuing during admission, patients do not need additional thromboprophylaxis

if INR >2. If INR <2, start LMWH, in addition to warfarin, until INR ≥2

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Appendix 3: Mechanical methods of thromboprophylaxis

Use of Graded Elastic Compression Stockings (GECS)

This option should be considered only if LMWH is contraindicated or patient needs additional prophylaxis in addition to LMWH. However, it shouldn’t be used after acute stroke.

Anti-embolism stocking is a mechanical VTE choice of prophylaxis. NICE guideline (2007) recommends thigh-length stockings, however if they are inappropriate for a particular patient, for reasons of compliance or fit, knee-length stockings may be used as a suitable alternative. Patients should be encouraged to wear their anti-embolism stockings until they return to their usual level of mobility. It is recommended that stockings be removed daily to facilitate inspection of skin integrity and to enable washing and moisturising, however this may vary in a community setting.

If patient needs other forms of mechanical VTE prophylaxis (Foot impulse devices or Intermittent pneumatic compression devices), then please contact local on-call medical team for advice.

Anti-embolism stockings (also known as Pressure stockings)

a) Do not offer anti-embolism stockings to patients with:i. Suspected or proven peripheral arterial disease

ii. Peripheral arterial bypass graftiii. Peripheral neuropathy or other causes of sensory impairmentiv. Local condition in which stockings may cause damage, such as fragile ‘tissue paper’ skin,

dermatitis, gangrene or recent skin graftv. Known allergy to material of manufacture

vi. Leg oedema with or without Cardiac failurevii. Unusual leg size or shape

viii. Major limb deformity preventing correct fit.

Use caution and clinical judgement when applying anti-embolism stockings over venous ulcers or wounds.

b) Measure legs and use correct stocking size. Staff who fit stockings should be trained in their use and should show patients how to use them.

c) If oedema or postoperative swelling develops, ensure legs are re-measured and stockings refitted.

d) If arterial disease suspected, seek expert opinion from Vascular surgery team.e) Use stockings that provide graduated compression and produce a calf pressure of 14–15

mmHg.f) Encourage patients to wear the stockings day and night from admission until they no longer

have significantly reduced mobility.g) Remove stockings daily for hygiene purposes and to inspect skin condition. If patient

has significant reduction in mobility, poor skin integrity or sensory loss, inspect skin two or three times per day, particularly over heels and bony prominences.

h) Discontinue use of stockings if there is marking, blistering or discolouration of skin, particularly over heels and bony prominences, or if patient has pain or discomfort.

i) Show patients how to use anti-embolism stockings correctly and ensure they understand that this will reduce their risk of developing VTE.

j) Monitor use of anti-embolism stockings and offer assistance if they are not being worn correctly.

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Appendix 4: Patient Information leaflet

Patient informationNov 2012 (v. 1.4); to be reviewed in Nov 2014

Venous ThromboembolismReducing the risk of a blood clot after admission to hospital

What is Venous Thromboembolism?

When a blood clot is formed deep inside one of the veins in your body, most commonly in the leg, it is called Deep Vein Thrombosis (DVT). It can slow or block the blood flow. Sometimes these clots break off and become lodged in one of the arteries of the lung. This is a potentially serious condition called a Pulmonary Embolism (PE) which can be fatal. DVT and / or PE are known as Venous Thromboembolism (VTE).

How common is Venous Thromboembolism (VTE)?

It is estimated that about 1 in 1,000 people have a VTE each year in the UK. It results in 25,000 deaths per year in England that potentially could have been prevented.

Who is at risk?

There are many risk factors for developing a VTE. Admission to hospital can increase the risk, especially if you are having an operation or are so unwell that you are confined to bed. Many other factors may increase your risk as well. Examples include age over 60 years, pregnancy, prolonged travel, overweight or a previous history of VTE either yourself or in your family. Conditions such as cancer, heart failure, respiratory disease and some medications, e.g. certain contraceptive pills, HRT etc. can increase risk.

What are the signs and symptoms to look out for?

A DVT in the leg can cause: swelling, pain, warm skin, tenderness or redness particularly in the back of your leg behind the knee. A DVT usually (but not always)

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affects one leg. The pain can be made worse by bending your foot upwards towards your knee. In some cases there may be no signs or symptoms at all in the leg.

The problem may sometimes become more apparent when a clot travels to the lungs obstructing the blood flow which is called PE. The signs and symptoms of a PE include: unexplained breathlessness, stabbing pains in the chest or back, coughing up blood or even a collapse (in some cases).

However, every patient developing VTE might not get all the symptoms.

What can be done to reduce the risk of developing VTE in hospital?

Before a planned hospital admission, keep mobile at home as much as possible. If walking is difficult for you, foot exercises will also help – for example extending, flexing and circling the feet. Active mobilisation may be the only precaution required in the absence of any risk factors. You should also drink plenty of fluids, avoid smoking and talk to your doctor if you are taking the contraceptive pill or Hormone Replacement Therapy (HRT) as they may increase your risk of VTE. While in hospital, your risk of developing a thrombus will be assessed and action will be taken. You will be mobilised as soon as possible under guidance from medical team. You should keep well hydrated. If we think you are at fairly high risk of VTE, then we may give you some medication (anti-coagulant) which stops the blood from clotting too quickly. The drug we normally prescribe is given as a small injection. A tablet may be prescribed if you are having or had a hip or knee replacement surgery. If you are not suitable for drugs, then, you may be fitted with a pair of special stockings (called TED) until you are fully mobile, or for a period of six weeks post surgery.Please remember to tell your doctor if you are already taking an anticoagulant medication as you may not need any extra medication.When you go home from hospital, continue to follow general advice. Your anticoagulant medication may be stopped or continue for a while at home. If you are given TED stockings consider wearing them until you return to your normal level of mobility (moving about).

How effective is thromboprophylaxis?

Thromboprophylaxis is highly effective. However, VTE can still occur despite appropriate preventive measures being taken but is a treatable condition. If you suspect you have a DVT or PE developing, please call your GP or go to the Accident & Emergency department for immediate assessment.

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What are the possible side effects of the treatment? If you follow the advice given about how to take your medication, it is unlikely that you will experience any problems. Because medications encourage the blood to flow rather than to clot, you may notice that you may bleed more than normal, or bruise more easily. If this occurs please discuss this with your nurse or doctor. However, you should inform the doctor immediately, if you notice: blood in your bowel motions or urine, coughing or vomiting blood, heavy or persistent nosebleeds, very heavy period or unexpected vaginal bleeding.

Who can I contact for more Information?

If you have any questions or would like any more information, please just ask your doctor, nurse or pharmacist.

PLEASE LET US KNOW IF YOU REQUIRE A LARGE PRINT VERSION OF THIS SHEET OR NEED AN INTERPRETER OR A PERSON TO ‘SIGN’

Author: Dr. Sangeeta Ray & Dr. Pravin Jha, Mount Vernon Hospital, Barnsley. Tel. 01226 43 3387

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Appendix 5

Audit tool

Minimum requirement to be monitored:

1. 100% of inpatients receive an assessment of VTE and bleeding risk using the clinical risk assessment criteria (Appendix 1).

2. 100% ‘At risk’ patients and their carer’s are offered verbal and written information on VTE prevention as part of the admission process.

3. 100% Patients provided with anti-embolism stockings have them fitted and monitored in accordance with NICE guidance and locally agreed policy.

4. 100% Patients assessed to be at risk of VTE are offered VTE prophylaxis

5. 100% ‘At risk’ patients and their carer’s are offered verbal and written information on VTE prevention as part of the discharge process.

6. 100% of identified patients are offered extended (post hospital) VTE prophylaxis in accordance with NICE guidance and locally agreed policy.

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Moderate/Severe and Life-Threatening Bleeding

Newer Oral Anticoagulant Related Bleeding

General measures Assess clinical bleeding and resuscitate patient as appropriate Check: FBC, U&E, LFT, Glucose and Clotting screen for PT, APTT, TT and fibrinogen Indicate time of last drug dose taken when requesting test

STOP Newer Oral Anticoagulant Therapy

Local measures only

Delay next dose of oral anticoagulant or discontinue as appropriate

Minor Bleeding

For Life-Threatening Bleeding consider Rivaroxaban / Apixaban: Prothrombin complex concentrate (Bereplex) 50 international Units/Kg as a single dose. If

bleeding continues, recombinant factor VIIa (Novoseven) 90 microgram/kg iv bolus Dabigatran: recombinant factor VIIa (Novoseven) 90 microgram/kg iv bolus. May need further doses 2-3hourly until the

bleeding stops. Haemodialysis, if renal failure present

Repeat FBC and clotting screen after blood product replacement

Appendix 6

Barnsley Guideline for the Management of Bleeding with Newer Oral Anti-Coagulants (Version 1; Nov 2012, to be revised in Nov 2013)

Newer oral anti-coagulants inhibits factor X (Rivaroxaban, Apixaban) or thrombin (Dabigatran) in the coagulation cascade.

65% of Rivaroxaban, 80% of Dabigatran and 27% of Apixaban are excreted via kidneys. There is no specific reversal agent for the above drugs and their anticoagulant effect will not be reversed

by administration of Vitamin K or plasma infusion.

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Discuss with Hematologist on-call Consider specific anti Xa assay for Rivaroxaban/Apixaban level measurement (discuss

with Haematologist) Consider local measures –

o Mechanical compression o Consider surgical/radiological/endoscopic intervention or wound packing

Give Oral liquid charcoal with sorbitol 50 g x 1 dose if drug ingestion within 2 hours Maintain good urine output with fluid replacement Consider blood product transfusion to keep:

Hb >8.0 g/dL Platelet >80x109/L Fibrinogen >1.0 g/L

Consider iv Tranexamic acid (1gram bolus over 10 min) and repeat bolus if bleeding persists

Interpretation of coagulation screenA normal aPTT or TT makes newer anticoagulant induced therapeutic anticoagulation unlikely

Moderate to Severe bleeding: reduction in Hb = 2gd/L, transfusion of = 2 units of red cells or symptomatic bleeding in critical area (i.e. intraocular, intracranial, intraspinal, intramuscular with compartment syndrome, retroperitoneal, intraarticular or pericardial bleeding). Life-threatening bleeding: symptomatic intracranial bleed, reduction in Hb = 5gd/L, transfusion of = 4 units of red cells, hypotension requiring inotropic agents or bleeding requiring surgical intervention.

Rerferences North East London Haematology Group. April 2012. Guidelines for management of bleeding with Dabigatran. North East London Haematology Group. April 2012. Guidelines for management of bleeding with Rivaroxaban. New Zeland Government. Guidelines for management of bleeding with Dabigatran (June 2011) University of Utah Hospitals and Clinics Standard. Principle and guidance for the reversal of effect and management of life threathening or major bleeding with

Dabigatran (Feb 2011) Acute management of bleeding in patients on novel oral anticoagulants Eur Heart J first published online December 7, 2012

Appendix 7

References

1. NICE 2007 reducing the risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism) in patients undergoing surgery. Clinical Guideline 92. National Institute of Clinical Excellence. http:/ / gu i dan c e.n ic e . o r g . u k / C G 9 2

2. Risk assessment tool http:// w w w .dh. g o v .u k / en/Pu b l i c a t i o n s a nd s t a t is t ics /Pu b lic a t i o n s /Pu b l i c a t i o n s P o l i c y A nd G u i d a n c e / DH _ 0 8 8 215

3. Academy of Medical Royal colleges (Sept 2012) Prevention of venous thromboembolism. http://www.aomrc.org.uk/publications/statements.html

4. Report of the expert working group on the prevention of venous thromboembolism (VTE) in hospitalised patients CEM/CMO/2007/10

5. Thrombosis: Awareness, Assessment, Management and Prevention. An Audit of Acute Hospital Trusts. All-Party Parliamentary Thrombosis Group. November 2007

6. National patient safety Agency (Feb 2011): How to guide ‘Venous thromboembolism Risk assessment http://www.nrls.npsa.nhs.uk/resources/?entryid45=94727

7. The DH VTE e-learning module: http://e-lfh.org.uk/projects/vte/launch/

8. NICE 2012: Rivaroxaban for the treatment of deep vein thrombosis and prevention of recurrent deep vein thrombosis and pulmonary embolism http://guidance.nice.org.uk/TA261

9. NICE 2012: Apixaban for the prevention of venous thromboembolism after total hip or knee replacement in adults. http://guidance.nice.org.uk/TA245

10. NICE 2009: Rivaroxaban for the prevention of venous thromboembolism after total hip or total knee replacement in adults. http://www.nice.org.uk/guidance/TA170

11. NICE 2008: Dabigatran etexilate for the prevention of venous thromboembolism after hip or knee replacement surgery in adults http://guidance.nice.org.uk/TA157

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Appendix 8

Equality Impact Assessment Tool

Equality Impact Assessment Questions:

Evidence based Answers & Actions:

1 Name of the policy that you are Equality Impact Assessing

Policy for Venous Thromboembolism prophylaxis in adult patients

2 Describe the overall aim of your policy and context?

Who will benefit from this policy?

The purpose of this policy is to provide guidance to clinical staff on VTE prophylaxis to ensure compliance with NICE Clinical Guidance.

Those staff and patients covered by the policy.

3

4

Who is the overall lead for this assessment?

Who else was involved in conducting this assessment?

Medical Director

Business Manager, Medical Directorate

5 Have you involved and consulted service users, carers, and staff in developing this policy?

What did you find out and how have you used this information?

See section 4 for those that have been consulted

Feedback received has been incorporated in the policy where appropriate

6

7

What equality data have you used to inform this equality impact assessment?

What does this data say?

N/A

N/A

8 Have you considered the potential for unlawful direct or indirect discrimination in relation to this policy?

It is not felt the Policy promotes unlawful direct or indirect discrimination. It allows for a Trust-wide process to be communicated which will ensure a common process to be followed.

9 Taking into account the information gathered.Does this policy affect one group less or more favourably than another on the basis of:

The policy provides for all adult in-patients and day patients under the care of SWYPFT, irrespective of the equality group.

YES NO

Race N

20

Disability N

Gender N

Age N The Trust does not have beds for patients under the age of 18

Sexual Orientation N

Religion or Belief N

Transgender N

10 What measures are you implementing or already have in place to ensure that this policy:

promotes equality of opportunity,

promotes good relations between different equality groups,

eliminates harassment and discrimination

Regardless of gender, race, disability, age etc, this policy provides for a standard of assessment to identify patient’s risk factors for developing VTE

11 Have you developed an Action Plan arising from this assessment?

If yes, then please attach any plans at the back of this template

N/A

12 Who will approve this assessment and when will you publish this assessment.

Executive Management Team

Appendix 921

Checklist for the Review and Approval of Procedural Document

Title of document being reviewed: Yes/No/Unsure Comments

1. Title

Is the title clear and unambiguous? Yes

Is it clear whether the document is a guideline, policy, protocol or standard?

Yes

2. Rationale

Are reasons for development of the document stated?

Yes

3. Development Process

Is the method described in brief? Yes

Are people involved in the development identified?

Yes

Do you feel a reasonable attempt has been made to ensure relevant expertise has been used?

Yes

Is there evidence of consultation with stakeholders and users?

No

4. Content

Is the objective of the document clear? Yes

Is the target population clear and unambiguous?

Yes

Are the intended outcomes described? Yes

Are the statements clear and unambiguous? Yes

5. Evidence Base

Is the type of evidence to support the document identified explicitly?

Yes

Are key references cited? Yes

Are the references cited in full? Yes

Are supporting documents referenced? Yes

6. Approval

Does the document identify which committee/group will approve it?

Yes

If appropriate have the joint Human Resources/staff side committee (or equivalent) approved the document?

N/A

7. Dissemination and Implementation

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Title of document being reviewed: Yes/No/Unsure Comments

Is there an outline/plan to identify how this will be done?

Yes

Does the plan include the necessary training/support to ensure compliance?

Yes

8. Document Control

Does the document identify where it will be held?

Yes

Have archiving arrangements for superseded documents been addressed?

Yes

9. Process to Monitor Compliance and Effectiveness

Are there measurable standards or KPIs to support the monitoring of compliance with and effectiveness of the document?

No

Is there a plan to review or audit compliance with the document?

Yes

10. Review Date

Is the review date identified? Yes

Is the frequency of review identified? If so is it acceptable?

Yes

11. Overall Responsibility for the Document

Is it clear who will be responsible for implementation and review of the document?

Yes

Appendix 10

23

Version Control Sheet

Version Date Author Status Comment / changesVersion 1 February

2013Dr N H Booya

Active

Version 2 March 2015

Dr. Pravin Jha

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