Government of Western Australia

Department of Health Sir Charles Gairdner Hospital

Clinical Practice Guidelines (CPG) for the Pharmacological Management of Deep Vein Thrombosis PATIENT SELECTION Inclusion Criteria: SCOPE Patients with limb Deep Vein Thrombosis, who have undergone assessment and examination by a registered medical practitioner (Intern, RMO, Registrar or Consultant) and have been diagnosed by ultrasound doppler are eligible for referral to the SCGH Home Link Anticoagulation Service. Upon referral further risk screening will occur to determine suitability for the implementation of this CPG. Patients must meet Home Link HITH risk assessment requirements around consent to treatment, safety in the home and appropriate communication device. A recent history of and/or the development of any of the following conditions: - bleeding; - uncontrolled hypertension; - significant thrombocytopenia; - significant hepatic impairment; - suspicion of pulmonary embolism (PE) or chest pain (including SOB, tachycardia, hypotension (if confirmed move patient onto PE CPG); or - neurovascular compromise. Pregnant women can be referred to the service but will be managed on Clexane. OUTCOMES Identify patients suitable for Anticoagulation NP DVT CPG.

Exclusion Criteria:

Identify patients not suitable for DVT CPG and exit them service by re-directing care to referring medical team or Emergency Department.

Implement DVT CPG for Clexane for pregnant women.

PATIENT ASSESSMENT Patient History and Primary Survey

ASSESSMENT AND INTERVENTIONS Initial assessment will include but not limited to: history of presenting complaint; risk factors for DVT (including smoking, oral contraceptive pill, venothromboembolism family +/previous history, cancer); risk factors for bleeding as per WA Anticoagulation Medication Chart or use of warfarin (including age >65 years, liver disease, renal impairment, fever and hyperthryroidism). past medical history including medication (prescribed, over the counter and complementary medications) and allergies; and social circumstances and occupation. Assess limb for swelling, pain, redness and superficial venous dilatation. Review ultrasound doppler. If high clot load identified by referring medical team then patient may require admission. If evidence of Pulmonary Embolism i.e. chest pain, shortness of breath, tachycardia, hypotension. Limb measurements Pain classification in terms of intensity (pain score), location, duration and characteristics. Commence anticoagulation regimen per DVT CPG.

OUTCOMES Identify patients not suitable for Anticoagulation NP DVT CPG and exit from service.

Focused Clinical Examination

Identify patients not suitable for Anticoagulation NP DVT CPG and exit from service. Identify patients not suitable for Anticoagulation NP DVT CPG and exit from service.

First Line Interventions

Reduction of or relief from pain. In the presence of chest pain exit patient from DVT CPG and refer to PE CPG or contact referring medical team.

DIAGNOSIS & INVESTIGATIONS Pathology

TIMELINE Day 1 or on review in ED: Review or initiate full blood count, urea and electrolytes, liver function tests and International Normalised Ratio (INR). A Thrombophilia screen is routinely indicated for all patients less than 50 years of age with unprovoked DVT. The Thrombophilia screen includes: (Factor V Leiden, Activated Protein C Resistance, Protein C, Protein S, Lupus Anticoagulant, Antithrombin III, Prothrombin Gene Mutation and Homocysteine levels). Homocysteine needs to be requested separately (not included in Thrombophilia screen) APC Resistance is a screening test for Factor V Leiden (if APCR abnormal then F5L is added on) Day 2: Nil (unless there are signs of bruising or bleeding).

OUTCOMES Renal and liver function tests determine the initial drug dosage and frequency. INR prior to and during drug therapy provides guide to drug dosage. FBC provides information on platelet count prior to drug therapy and can guide NP in the decision making process regarding the commencement and continuation of drug therapy. Thrombophilia screening can assist in the identification of congenital and acquired causes of Thrombophilia which will then be referred to Haematology for ongoing management.

Day 3 -7: Daily or second daily INR until target INR reached (2.0-3.0) using the POC INR Coagucheck machine (with POC approved guidelines). Full Blood Count at Day 5 if patient on Clexane.

INTERPRETATION OF RESULTS AND MANAGEMENT Clinical and Physical Assessment

ACTION

FBC provides information on platelet count during drug therapy and can guide NP in the decision making process regarding the continuation of drug therapy. POC guidelines formulated for internal and external quality assurance as well as competency programs. OUTCOME

Assess general vital signs as well as: Review and measure limb for swelling, pain, redness. Evidence of Pulmonary Embolism i.e. chest pain, shortness of breath, tachycardia, hypotension.

Pathology

Order routine Pathology blood relating to management of anticoagulation patients including (FBC, coagulation profile, urea and electrolytes, Thrombophilia

Daily vital signs will determine patients condition. Measurement of legs will determine risk of Post Thrombotic Syndrome and reduction of clot size. If there is evidence of a PE the patient will exit this CPG and continue on PE CPG. Ensure optimal management of patients on SCGH Anticoagulation service.

Positive Thrombophilia Screen

screening, and Anti-Xa assay) Ensure Day 5 FBC to check platelet levels for Heparin Induced Thrombocytopenia (as per HITH Anticoagulation Pathway). Discuss with HITH Registrar or Consultant in regards to referring to Haematology for long term management of a positive Thrombophilia screen. Warfarin drug therapy will be titrated for INR 2.0-3.0. In the event of an excessive INR or difficulty in gaining therapeutic INR levels the NP will initiate collaboration with HITH or Haematology Registrar. Excessive INR will be managed as per guidelines for the management of an elevated INR in adult patients with or without bleeding (Baker et al, 2004). Therapeutic INR for at least two days will initiate transfer of care to patients GP. If clinically significant Thrombocytopenia (with platelets <120 g/L) prior to commencement of therapy, consult referring team. If Thrombocytopenia or a drop in platelet count of ~50% during therapy occurs, refer patient back to referring team. If clinical signs of abdominal bleeding or retroperitoneal haematoma develop consult referring team or HITH Registrar. Fitting of compression stocking 2030mmgh will reduce risk of Post Thrombotic Syndrome. ACTION

International Normalised Ratio (INR)

Routine DVT management of patient coordinated by NP in the short term. Will need input from Consultant for long term anticoagulation management. Aim for INR 2.0-3.0 for two consecutive days prior to discontinuation of Enoxaparin. If INR levels remain subtherapeutic or excessive exit CPG and refer to the HITH Registrar or ED.

Full Blood Count (FBC)

When INR is therapeutic transfer care to patients GP. Patient to exit DVT CPG and follow alternative medical team initiated protocol. Patient to exit DVT CPG and follow alternative medical team initiated protocol. Exit CPG and refer patient to ED.

Radiology

Stockings

FOLLOW UP AND EDUCATION Follow-up Appointments

Ensure patient understands the importance of wearing compression stockings as a treatment modality. OUTCOME Ensure patient understands diagnosis and management plan and is safe for discharge home. Follow up appointment to be organised at cessation of treatment in Home Link Anticoagulation Clinic by medical registrar and Anticoagulation NP.

Verbal instructions from NP.

Refer patient to Home Link Anticoagulation clinic at end of treatment depending on whether provoked or unprovoked DVT.

Other Referrals

Referrals may be made for specific patient problems or as required e.g. Silver Chain, Haematology, Respiratory Medicine, Allied Health. Provide medication education for anticoagulation and other medications as necessary and any relevant written information per SCGH Pharmacy guidelines. Ensure patient has Warfarin information booklet (2010).

Medication Education

Certificates

Absence from work certificates. Other certificates as deemed appropriate.

Ensure quality care is provided and appropriate agencies and specialties are involved in anticoagulation management. Ensure patient understands diagnosis and management plan and is safe for discharge home. Patient uses the medication in an effective and safe manner. Prescribing NP to be informed of significant adverse medication effects. Appropriate documentation completed however refer Workers Compensation certificates to Home Link Registrar. Ensure that quality and safety guidelines are adhered to in the provision of comprehensive patient care. OUTCOME Patient will use the medication in an effective and safe manner. Prescribing NP will be informed of significant adverse effects of medication. Prescription for dispensing at SGCH outpatient pharmacy or via HITH pharmacist; or Recommendation for purchase of medication at a community pharmacy. Pain relief administration in HITH clinic and/or recommendation for purchase at a community pharmacy. Additional monitoring of INR may be necessary. SCGH NP Outpatient prescription or via SCGH Outpatient Pharmacy.

Medications

PRESCRIBING MEDICATION General Information

All medication will be stored, labelled and dispensed in accordance with SCGH policy and relevant legislation (references included). DRUG FORMULARY Patient will be educated regarding medication usage, potential adverse effects and course of action to take in event of adverse effect.

First Line Treatment Analgesia

Administration, recommendation or prescription of analgesics.

Analgesia Mild pain (S2)

Oral paracetamol 0.5 to 1.0g, 4-6 hourly and not to exceed 4g in 24 hours.

Analgesia Moderate pain (S4) If paracetamol is minimally effective, substitute: - Panadeine 1-2 tabs, 4-6hrly with a maximum of 8 tablets in 24 hrs (only suitable for adults) OR - Panadeine Forte 1-2 tabs, 4-6hrly with a maximum of 8 tablets in 24 hrs (only suitable for adults). OR

Low Molecular Weight Heparin (S4)

Anticoagulant: Warfarin (S4)

- Tramadol 50-100 mg twice daily with a maximum of 300 mg/day in the elderly. Use for adults and children > 12 yrs. If pain control is not effective as per pain score or is not to the satisfaction of the patient refer to HITH Registrar. 1.5mg/kg SC once daily (maximum dose 150mg (Maximum order 10) OR 1mg/kg SC twice daily If a larger dose is required >150mg refer to the admitting team Registrar or ED Registrar unless patient has had Anti-XA assay to ensure enoxaparin dosage is therapeutic. If creatinine clearance <30ml/min use 1mg/kg once daily dosage regimen. Enoxaparin will be discontinued when INR 2.0-3.0 for two consecutive days and after a minimum of five days of treatment. Minor bleeding will be managed utilising first aid treatments, reassessment of clotting times and referral to the HITH Registrar or referring team. Major bleeding initiate urgent transfer to local ED. Dosing regimen as per INR (Qty 50). Target INR is 2.0-3.0 (oral route). Patient will be transferred back to GP care when INR 2.0-3.0 for two consecutive days and minimum of five days of enoxaparin treatment given. Duration of warfarin will be determined by referring team and patient followed up in Anticoagulation Clinic at end of treatment regimen.

If inadequate pain control persists exit CPG and consult with referring team or request review in ED. SCGH NP Outpatient prescription or via SCGH Outpatient Pharmacy. Prescription for dispensing by Silver Chain pharmacy.

Calculate creatinine clearance using the Cockcroft-Gault equation. Exit DVT CPG.

Resolution of bleeding and continue CPG.

Exit DVT CPG.

Excessive INR and or bleeding considered to be contributed by Warfarin-induced coagulopathy will be managed as per guidelines for the management of an elevated INR in adult patients with or without bleeding (Baker et al, 2004). Refer patient to ED if major active bleeding is suspected or present. If minor bleeding occurs or is suspected, it will be managed with first aid treatments, reassessment of

Patient prescribed medication appropriate to known adverse drug reactions, current medications and medical history. SCGH NP Outpatient prescription or via SCGH Outpatient Pharmacy. Prescription for dispensing by Silver Chain Pharmacy. Achievement of therapeutic INR will initiate transfer of patient back to GP. Resolution of DVT. D/C communication to be forwarded to GP. Exit DVT CPG.

Resolution of bleeding.

Oral Vitamin K Warfarin Antagonist (S4)

clotting times and if necessary adjustment of drug regime as per guidelines for the management of an elevated INR in adult patients with or without bleeding. As per guidelines for the management of an elevated international normalised ratio in adult patients with or without bleeding (Baker et al, 2004). Vitamin K therapy will be implemented in collaboration with either the HITH or Haematology Registrar.

Patient prescribed medication appropriate to known adverse drug reactions, current medications and medical history. This will be done in collaboration with appropriate teams.

Acknowledgements to Royal Perth Hospital for their valued advice and support in regards to the creation of this Clinical Practice Guideline. References Australian Medicines Handbook. 2008 [cited 2011 October 11]. American College of Chest Physicians. Evidence-Based Clinical Practice Guidelines (8th Edition). Chest (2008) 133: 383-393S. American College of Emergency Physicians. Clinical policy: critical issues in the evaluation and management of adult patients presenting with suspected lower extremity deep vein thrombosis. Ann Emerg Med (2003) 429: 124-135. Baker R, Coughlin P, Gallus A, Harper P, Salem H, Wood E. Warfarin reversal: consensus guidelines on behalf of the Australasian Society of Thrombosis and Haemostasis. Med J Aust (2004) 181: 492497. Cardiovascular Therapeutic Guidelines (5th Version). 2008 [cited 2011 October 19]. Eikelboom J, Baker R. Routine home treatment of deep vein thrombosis is now a reality. Brit Med J (2001) 322: 1191-1193. eMIMS 2011 [cited 2011 October 11]; Available via Hospital Intranet. Hirsh J., Warkentin T.E., Shaughnessy S.G., Anand S.S., Halperin J.L., Raschke R., Granger, C., Ohman E.M. & Dalen J.E. Heparin and low-molecular weight heparin: Mechanisms of action, pharmacokinetics, dosing, monitoring, efficacy and safety. Chest (2001) 119: 64S-94S. Ho W., Hankey G., Lee C. & Eikelboom J. Venous thromboembolism: diagnosis and management of deep vein thrombosis. Med J Aust (2005) 182: 476-481. SCGH Medication Storage and Administration Policy. Available via Hospital Intranet WA Anticoagulation Medication Chart (3rd Version). 2009. Winter M, Keeling D, Sharpens F, Cohen H, Vallance P. Procedures for the outpatient management of patients with deep vein thrombosis. Clin Lab Haem (2005) 27: 61-66.