South Staffordshire and Shropshire Healthcare NHS Foundation Trust
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1 South Staffordshire and Shropshire Healthcare NHS Foundation Trust Document Version Control Document Type and Title: Authorised Document Folder: Venous Thrombo-Embolism Policy YELLOW - Clinical New or Replacing: New Document Reference: C/YEL/cm/14 Version No. v1.0 Implementation Date: May 2014 Policy Owner: Approving body: Dr Ejaz Nazir, Consultant Old Age Psychiatrist Dr Tim Devanney, Senior Nurse Quality Governance Committee Approval Date: 10 th April 2014 Ratifying body: Board of Directors Ratified Date: 24 th April 2014 Committee, Group or Individual Monitoring the Document: Medicines Management Committee Review Date: April
2 Contents 1. Policy Statement: Summary Scope of the Policy Background Definitions Duties and Responsibilities... 5 a. Medical Staff... 5 b. Nurses... 5 c. Matrons... 5 d. Allied Health Professionals... 5 e. Deputy Director of Nursing Risk Assessment Risk assessment : pregnancy and 6 weeks post partum Prophylactic measures against VTE... 7 a. Low molecular weight Heparins (LMWH)... 7 b. LMWHs and antiplatelet or anticoagulant therapy... 7 c. Unfractionated heparin (UFH) Contraindications to heparins: Mechanicalprophylaxis Treatment of a newly diagnosed D.V.T. (Deep Vein Thrombosis) Contraindications To Anti Coagulation: Side Effects Of Low Molecular Weight Heparin: Information Required When Requesting An I.N.R Discharging patients Training and competency assessment Root Cause Analysis for Hospital - Acquired VTE Process for monitoring compliance and effectiveness Process for monitoring compliance and effectiveness Web resources
3 1. Policy Statement Patients have a right to be protected from preventable harm and healthcare staff have a duty to safeguard the wellbeing of their patients. In January 2010 the National Institute for Clinical Excellence (NICE) launched an updated guideline Venous thrombo-embolism: reducing the risk (VTE) (CG-92 / 2010). This policy outlines the Trusts approach to implementing and monitoring the national best practice in relation to VTE. Please read the policy in conjunction with this NICE guidance and the associated materials such as the quick reference and implementation documents. 2. Summary (this document at a glance) Please refer to Appendix 1 Action Flow Chart. All in-patients should have a documented risk assessment performed at presentation with a decision recorded regarding venous thromboembolism (VTE) prophylaxis or treatment. The risk assessment must be completed as part of the physical health care pathway and retained within the healthcare record. The prophylaxis and treatment interventions will be in line with NICE Guidance (Clinical Guideline 92, January 2010). General preventative measures (early mobilisation, leg exercises and ensuring adequate hydration) are appropriate for all patients. Pharmacological or mechanical prophylaxis should be clearly recorded and included within a care plan for those at significant risk of VTE. The risk assessment must be reviewed within 24 hours of an admission then weekly and whenever the clinical situation changes, to:- ensure that the methods of VTE prophylaxis being used are suitable that they are being used correctly to identify adverse events resulting from VTE prophylaxis. Before starting VTE prophylaxis patients and/or their families or carers should be offered information on:- the risks and possible consequences of VTE the importance of VTE prophylaxis and its possible side effects the correct use of VTE prophylaxis how patients can reduce their risk of VTE (such as keeping well hydrated and, if possible, exercising and increasing mobility). Discharge and care plans for use outside inpatient settings must include the provision of verbal and written information on the signs and symptoms of VTE and pulmonary embolism and the correct and recommended advice on the use of VTE prophylaxis at home (if discharged with prophylaxis). 3
4 Completion rates of VTE risk assessment and VTE associated data will be reported as required by regulatory, commissioning bodies and other authoritative bodies such as the Patient Safety Thermometer. Outcome data on the rates of VTE will be collected and cases of VTE occurring within three months of hospital admission will be subject to a root cause analysis. Commissioners review compliance with this policy and supporting National Best Practice guidance. 3. Scope of the Policy This document applies to all Trust in-patient units and the clinical staff who care for those patients. 4. Background (VTE) is a common, potentially fatal, disease that is likely to increase in prevalence due to an aging population (Alikhan et al, 2004). An estimated 25,000 people in the UK die from preventable hospitalacquired venous thrombo-embolism (VTE) every year. Treatment of non-fatal symptomatic VTE and related long-term morbidities is associated with considerable cost to the health service. There is evidence that routine prophylaxis reduces morbidity, mortality and costs in hospitalised patients at risk of DVT (Scottish Intercollegiate Guidelines Network (SIGN), 2002; Nicolaides et al, 1992 ;Geerts et al, 2004). 5. Definitions a. Deep Vein Thrombosis. (DVT) a condition which starts when a blood clot (a thrombus) forms in a vein. It most commonly occurs in the deep veins of the legs and sometimes in the arms. b. Embolism, when the thrombus dislodges from its site of origin to travel in the blood to other parts of the body. c. Pulmonary Embolism If the embolism blocks the blood supply to the lungs you have a (PE) which is a serious, potentially lifethreatening, condition. d. Venous Thromboembolism, DVT and PE together are known as venous thrombo embolism (VTE). e. Thromboprophylaxis, the treatment to prevent blood clots forming in veins 4
5 6. Duties and Responsibilities All patients admitted to hospital must be routinely assessed for VTE NICE clinical guideline 92 (2010) [Venous thromboembolism: reducing the risk of venous thromboembolism (deep vein thrombosis and pulmonary embolism). a. Medical Staff The doctor responsible for admitting the patient has clinical responsibility for ensuring that the initial risk assessment has been completed on admission to the ward and producing a management plan in line with this policy document. They must review the risk within 24 hours and as the patient s condition changes. The medical team are responsible for prescribing thrombo-prophylaxis as medically indicated and determining the need for anti-embolism stockings. This decision must be clearly documented in the health record and ward staff consulted and informed accordingly. Consultants must ensure that junior doctors adhere to the standards outlined in this policy. b. Nurses Nurses must ensure that they understand and are competent in the management of risk for VTE in their patients. They must be trained and supported by tissue viability nurses and matrons and competent to correctly measure and fit patients with anti embolism stockings where required. The ward staff are responsible for obtaining the stockings. The assessment nurse is responsible for signing and dating the risk assessment when admitting the patient. c. Matrons The matron provides clinical leadership for implementation of this policy and is required to keep themselves informed regarding significant national developments regarding VTE. They must act on new developments and evidence to influence local policy and practice. Matrons are responsible for the development and operational implementation of clinical arrangements for the management of VTE, e.g.:- - patient information relating to VTE - clinical training and competency tools for VTE - clinical audit tools - Doppler Assessments Matrons are responsible for attending and contributing to all meetings concerning VTE management, clinical leadership and monitoring. Clinical leadership responsibilities may be delegated but the accountability remains with the lead. d. Allied Health Professionals Allied health professionals, working within their professional code of practice and guidelines, will work with other colleagues to 5
6 reduce the risk of service users experiencing VTE and contribute to carers and families education around VTE. For example: physiotherapists, working closely with inpatient staff, assess and advise on exercises for those patients who are not mobile, and assess and advice graded exercise regimes for those with more mobility. Other AHP s (Occupational Therapists, Dieticians and Speech and Language Therapists), through interaction with service users, will, on signs of potential VTE take appropriate actions i.e. seek immediate medical advice. e. Deputy Director of Nursing The Deputy Director of Nursing is responsible for overseeing:- Development of this policy in accordance with national guidance Implementation into clinical practice Reporting to the Director of Nursing 7. Risk Assessment On admission all patients must be assessed using an approved VTE risk assessment tool for VTE (Appendix 2). The patient should be reassessed for risk after 24 hours and during the in-patient stay as the patient s condition changes or weekly as a minimum. Relevant risk factors are contained in the risk assessment documents. One risk factor identified indicates a patient is at risk and should prompt thromboprophylaxis. Two or more risk factors identified during assessment indicate the patient is at high risk of VTE. A bleeding risk assessment should also be undertaken at this time and any indicator identified should prompt consideration of whether the risk is sufficient to preclude pharmacological intervention. Patients must have a weekly review considering each of the three steps of the VTE risk assessment and as required prophylaxis. 8. Risk assessment : pregnancy and 6 weeks post partum There are specific risks factors for pregnant women up to 6 weeks post partum. In particular, consider offering pharmacological VTE prophylaxis with LMWH (or UFH for patients with renal failure) to women who are pregnant or have given birth within the previous 6 weeks who are admitted to hospital but are not undergoing surgery, and who have one or more of the following risk factors: expected to have significantly reduced mobility for 3 or more days active cancer or cancer treatment age over 35 years critical care admission dehydration excess blood loss or blood transfusion known thrombophilias obesity (pre-pregnancy or early pregnancy BMI over 30 kg/m2 ) 6
7 one or more significant medical comorbidities (for example: heart disease; metabolic, endocrine or respiratory pathologies; acute infectious diseases; inflammatory conditions) personal history or a first-degree relative with a history of VTE pregnancy-related risk factor (such as ovarian hyperstimulation, hyperemesis gravidarum, multiple pregnancy or pre-eclampsia) varicose veins with phlebitis. The NICE Quick Reference guide Pregnancy and up to 6 weeks postpartum is included Appendix 3). 9. Prophylactic measures against VTE Prophylactic measures include pharmacological and mechanical interventions. They are determined by the risk factors, clinical presentation and NICE clinical guideline 92 (2010). a. Low molecular weight Heparins (LMWH) LMWH should be considered as pharmacological prophylaxis for all in-patients assessed to be at increased risk of VTE (and risk of VTE outweighs risk of bleeding) The Trust Formulary demotes Enoxaparin 40mg (4000 units) sc every 24 hours. The indications, cautions and contraindications for the use are set out in the Summary of Product Characteristics for the individual products and listed in the latest edition of the British National Formulary. Particular areas of caution for these drugs are a history of bleeding or pathology increasing the risk of bleeding. b. LMWHs and antiplatelet or anticoagulant therapy LMWHs should be considered for patients already having antiplatelet or anticoagulant therapy to treat other conditions, if patient is at risk of VTE. However, the risk of bleeding and of comorbidities such as arterial thrombosis should be taken into account. Pharmacological interventions should be initiated as soon as clinically indicated and following the completion of the risk assessment. It should be continued until the patient is no longer at increased risk of VTE. c. Unfractionated heparin (UFH) LMWH should be used with caution when there is severe impairment of kidney function, and use of unfractionated heparin may be preferable to reduce risk of bleeding. Although no dosage adjustments are recommended in patients with moderate renal impairment (creatinine clearance ml/min) or mild renal impairment (creatinine clearance ml/min), careful clinical monitoring is advised. In sever renal impairment, when estimated GFR is <30ml/min, a reduced dose LMWH (e.g. Enoxaparin 20 units daily subcutaneous injection). 7
8 10. Contraindications to heparins Active bleeding, hypersensitivity to heparin, coagulopathy, severe liver disease, recent surgery, perforated peptic ulcer, pregnancy, endocarditis, history of Haemorrhagic Stroke, recurrent falls, thrombocytopenia, lumbar puncture or neuroaxial anaesthesia within 12 hrs, recent intraocular or intracranial surgery. Caution in uncontrolled hypertension. Patients need to be informed that when animal derived heparins are being offered. Synthetic alternatives to heparin should be offered wherever possible to patients who have concerns about using animal products for religious beliefs, since heparin is of animal origin. In the rare instance of haemorrhage, the emergency 999 service should be contacted. 11. Mechanicalprophylaxis a. Graded Elastic Compression Stockings (GECS) In the absence of contraindications properly fitted GECS are an adjunct or alternative to pharmacological prophylaxis when there is increased risk of bleeding from heparin use, due to patient or procedure related factors. NICE guidance recommends against the use of GECS in patients with acute stroke. b. Only competent staff after training may fit stockings. (see page 4b) They should fit the Sigel profile (a pressure profile for elastic stockings). They should be removed daily to inspect the skin and for hygiene purposes. Ensure that they are worn correctly and any event that leads to leg swelling or oedema should lead to the refitting of GECS. Knee length stockings are better tolerated and there is no evidence that thigh length stockings improve effectiveness. c. Anti-embolic stockings are to be used with patients who have or will undergo surgical procedures, have suffered major trauma, spinal injured patients and may be used alone for other at risk patients for whom pharmacological prophylaxis is contraindicated as an adjunct. Once patients have regained their normal level of mobility and other risks are eliminated stockings can be removed, however if their normal level of mobility cannot be regained medical further advice should be sought once the acute phase is resolved and their condition is stable. d. Stroke patients should not be offered anti-embolism stockings (NICE,2010). e. Other patient groups for whom anti-embolic stockings are contraindicated Include those with: Suspected or proven Peripheral Vascular Disease or vascular surgery Insensate leg (numbness) due to local anaesthesia block, neuropathy, diabetes etc. Cellulitis 8
9 Dermatitis Massive oedema Leg/foot ulcers (especially arterial leg ulcers) Gangrene Fragile tissue paper skin Cardiac failure Major limb deformity preventing correct fit Allergy to the material of manufacture Sensory impairment f. Anti-embolic stockings offer 17mmHg pressure to a limb; therefore assessment of the patient s limbs is of paramount importance prior to application. Application of anti-embolic stockings to an ischaemic limb can cause significant damage including the development of heel pressure ulcers. Caution and clinical judgement must be exercised where there are any wounds or venous ulcers. g. The practitioner must be aware of the following signs/symptoms which could indicate ischaemia: The limb is cold The limb is hairless The limb is dusky on dependence The limb blanches on elevation Pain at night when legs are elevated is common Foot pulses are absent or diminished palpate the pulses at the dorsalispedis artery (or the anterior tibial artery), the posterior tibial artery and the peroneal artery. Any wound to the lower limbs which appear deep or punched out. h. If one or more of these signs are present, a Doppler test should be carried out, prior to application of anti-embolism stockings, by either doctors, matrons or tissue viability nurses. If the Doppler reading is <0.8, medical advice should be sought prior to the application of anti-embolism stockings. Medical advice should also be sought if the patient has one of the following conditions: Severe oedema of legs Pulmonary oedema due to Congestive Cardiac Failure(CCF) Local leg conditions e.g. dermatitis, cellulitis or skin grafts in last 3 months Severe peripheral neuropathy Greater thigh/leg circumference than recommended by the fitting instructions Doppler assessments (Ankle Brachial Pressure Index), can be obtained by referral to the DGH and may only be carried out locally if there is a competent practitioner who has undertaken specialist training. Doppler training will only be undertaken by trained doctors and nurses. 9
10 i. NICE guidelines (2010) recommend 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. Anti-embolism stockings must not be left off for any longer than thirty minutes at a time. j. Intermittent Pneumatic Compression (IPC) devices (full or knee length) may be used when pharmacological prophylaxis is contraindicated. k. Foot Impulse Devices require correct use and should only be used as part of a specific medical plan. 12. Treatment of a newly diagnosed D.V.T. (Deep Vein Thrombosis) When a D-Dimer Assay test is 500 or more it is recommend that a Doppler Scan is arranged. Anti embolism stockings whilst waiting for a Doppler scan except in patients with contraindications such as follows: Peripheral Arterial Disease Cardiac Failure Severe leg oedema Localised skin conditions Peripheral Neuropathy / Sensory Impairment Commence a low molecular weight heparin by daily subcutaneous injection such as Tinzaparin Sodium (175 units/kg sc every 24 hours) or Enoxaparin Sodium (150 units per kg sc every 24 hours as per BNF) awaiting a Doppler scan (e.g. A 70kg gentleman = 175 x 70 = therefore units Tinzaparin is prescribed) Additionally commence Warfarin for three days after DVT has been confirmed by a Doppler Venogram Contact anticoagulant department to confirm initial dose of Warfarin On the fourth day check I.N.R. (International Normalisation Ratio) Continue with Tinzaparin Sodium or Enoxaparin Sodium until the I.N.R. is between 2 3 then discontinue. Continue with Warfarin for at least 3 months for first episode DVT or advised otherwise by the Haematologist. Follow the advice of the Haematologist for dose of Warfarin and re-test date of I.N.R. 13. Contraindications To Anti Coagulation Do not commence in patients with contra-indications without seeking further advice. These include: Recurrent falls Liver Disease Recent surgery Severe uncontrolled hypertension Pregnancy 10
11 Perforated peptic ulcer Haemorrhagic Stroke Known abnormal clotting Thrombocytopenia 14. Side Effects Of Low Molecular Weight Heparin If a low molecular weight heparin s/c injection is administered for 5 days or more Blood Platelets need to be monitored as it can cause Thrombocytopenia 15. Information Required When Requesting An I.N.R. Reason for staring Dose of Warfarin administered Previous I.N.R. result G.P. details Ensure the Anticoagulant Book is completed during a hospital admission and given to the patient on discharge 16. Discharging patients a. As with other treatments upon discharge nurses must:- Include the necessary information in their transfer / handover information prior to transfer to other care facilities. Clearly state the duration of treatment on discharge summary. b. If on-going treatment is required, nurses must discuss with the relevant care provider as well as the patient. 17. Training and competency assessment a. Education about the hazards of VTE, risk assessment and preventative methods is part of the Trust mandatory training process for qualified inpatient staff. The DH e-learning package for VTE thromboprophylaxis is available through the Electronic Staff Record and face to face at healthcare awareness days. b. Matrons and nursing staff involved with the measurement and fitting of anti-embolic stockings must be trained and recorded as competent and where appropriate supported by tissue viability nurses. 18. Root Cause Analysis for Hospital - Acquired VTE a. A Root Cause Analysis (RCA) will be completed for incidence of VTE that occur between 3 after days of admission and 12 weeks post discharge. b. The Matron, will complete a concise root cause analysis (RCA), to understand if there were any deficits in the patient s care and if any remedial action needs to be taken. Outcomes of the RCA will be sent to the Deputy Director of Nursing. 11
12 c. Any VTE associated serious untoward incidents (SUI) will be reported according to national guidance and monitored through the Commissioning Quality Review arrangements. 19. Process for monitoring compliance and effectiveness a. VTE monitoring is reported through the national Safety Thermometer and is based on the NICE guidance audit tool and the NICE Quality Standard. Training compliance will be reported in the monthly mandatory training reports. b. The Department of Health require information to ensure all patients have received a risk assessment. This is provided by the Trust to the DoH by the Performance Team 20. Process for monitoring compliance and effectiveness a. Data and information arising from the safety thermometer and mandatory training review will be reviewed as part of directorate management meetings and the Physical Healthcare meeting. b. The Deputy Director of Nursing has responsibility for monitoring this policy. 21. Web resources NICE Venous thromboembolism - reducing the risk (CG92) RCN Preventing VTE E-learning Web based training. This is better accessed through ESR as a record of your leaning is added to your competency profile.. 12
13 Appendix 1 13
14 Appendix 2 14
15 Patient Name NHS number Date Assessed Assessment No Assessors Name Assessors Signature 15
16 Appendix 2 Risk Assessment for Thromboprophylaxis Patient Name: Date of Birth: NHS Number: Reassessment Date Name of assessor Comment Signature 16
17 Appendix 3 17
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