Guideline for Patients on Direct Oral Anticoagulant Therapy Requiring Urgent Surgery for Hip Fracture Trust Ref:C10/2017 1. Introduction This guideline is for the clinical management of patients on direct oral anticoagulants (DOACs) with a hip fracture in whom surgery is being considered. 2. Scope This guideline applies only to patients with a hip fracture who are on direct oral anticoagulants, a class of drug which includes Rivaroxaban, Apixaban, Edoxaban and Dabigatran. 3. Recommendations, Standards and Procedural Statements DOAC and NOAC are terms for a novel class of directly acting oral anticoagulant drugs including Rivaroxaban, Apixaban, Edoxaban, and Dabigatran. Immediate management: Pre-operative phase Stop DOAC Document time and amount of last dose taken Document indication for anticoagulation and thrombotic risk (see attached thrombotic risk assessment tool appendices 1,2) Establish IV access and ensure adequate hydration, oxygenation and blood pressure maintenance Send urgent samples for FBC, U&E, LFT, G&S, clotting screen (PT, APTT and TT) and fibrinogen PRINT AND COMMENCE AUDIT RECORD (APPENDIX 1) AND FILE IN MEDICAL NOTES Follow advice below according to DOAC type Page 1 of 12
Dabigatran Contact Haemostasis team (weekdays 9-5) or on-call Haematology Registrar for Agreement to give reversal agent Idarucizumab (Praxbind) (to be administered by anaesthetist, and only indicated if TT is prolonged see notes below) Peri-operative bridging plan in high risk or unstable patients (see appendices 1,2) Proceed to surgery following discussion between surgery, anaesthesia, orthogeriatrics, haematology, and patient. Notes: i. A normal thrombin time (TT) rules out clinically significant plasma concentration of Dabigatran. In this case do not give Praxbind. ii. Prolonged TT only indicates presence of Dabigatran but gives no indication as to the degree of anticoagulation. iii. Prolonged TT, normal APTT suggests very minimal plasma concentration of Dabigatran. Surgery probably safe from an anticoagulant perspective. Discuss with haematology. iv. Praxbind should be given by an anaesthetist in theatre as there is a small risk of severe allergic / anaphylactic reaction. It is given intravenously as 2 consecutive infusions of 2.5g/50 ml, each over 5 to 10 minutes. If infused through a pre-existing IV line, this must be flushed with 0.9% sodium chloride before and after the infusion. Rivaroxaban / Apixaban If ingested within 2 hours give activated charcoal (available in ED). If PT > 20 seconds, Rivaroxaban level likely to be > 100 ng/ml PT > 40 seconds is unlikely to be solely due to Rivaroxaban or Apixaban. CONSIDER OTHER ANTICOAGULANT EFFECT OR OTHER CAUSE OF PT PROLONGATION. Please note that PT cut-off values suggested above are valid ONLY with our current PT reagent, Neoplastine CI Plus. Values may alter with change of reagent. Contact Haemostasis team (weekdays 9am-5pm) or on-call Haematology Registrar to Seek agreement to perform drug specific Anti-Xa assays Discuss peri-operative bridging plan in high risk or unstable patients (see appendices 1,2). Page 2 of 12
Ordering DOAC Levels To request Rivaroxaban or Apixaban specific Anti-Xa assay for drug specific plasma concentration: Take two citrated samples (green topped bottles) filled to the mark and transport by hand to Special Haematology laboratory (extension 6619), Level 2 Sandringham Building, Leicester Royal Infirmary. Do not send samples via hospital chute system. Tests should be done near to the time of surgery (e.g. in the morning for proposed afternoon surgery). Lab staff are on site 0830 1730 Monday Friday, and Saturday mornings, and are on-call outside these hours. Interpretation of Plasma Levels DOAC PLASMA CONCENTRATION ACTIONS, ASSUMING ALL HIP FRACTURE SURGERY HAS HIGH BLEEDING RISK < 30 ng / L Proceed With Surgery Multi Disciplinary Assessment of Risk vs Benefit of surgery (Anaesthesia, Orthopaedics, Orthogeriatrics, Haematology) Ensure Hydration Monitor Fluid Balance 30 100 ng / L Consider Octaplex (Prothrombin Complex Concentrate) 20 units /kg (can be repeated up to total dose 50 iu/kg: discuss with haematology). Please note that PCC is NOT a specific reversal agent for DOACs. Consider Repeating Anti-Xa assay after 12 hours Avoid neuraxial anaesthesia 100 400 ng / L Delay surgery by a minimum of 24 hours. Ensure hydration and monitor fluid balance. Repeat anti-xa assay after 24 hrs, and then every 12 hrs Page 3 of 12
Intra-operative Management of Patients with Residual DOAC Effect Consultant Surgeon and Consultant Anaesthetist to do case Give tranexamic acid 1g IV unless contraindicated (known sensitivity to tranexamic acid, arterial or venous thrombosis within the last 3 months, history of epilepsy / seizures or significantly impaired renal function {avoid where CrCl<20, lower dose of 10 mg/kg if CrCl 20-30, 1g if CrCl >30}). If subsequent doses required use 10mg/kg IV OR 0.5-1g IV TDS. Consider intra-operative cell salvage Ensure cross matched blood available Maintain Hb > 80 (> 90 if cardiovascular disease) Consider Intraoperative Prothrombin Complex Concentrate (Octaplex) Consider Use of TEG (note currently no data to support use of TEG in patients on DOAC) Fill in audit form and keep in medical notes Post-Operative Management Check FBC and U&E day 1 post surgery Restart DOAC after 48-72 hours providing bleeding risk low. Give standard prophylaxis with LMWH Follow bridging plan where recommended by Haemostasis & Thrombosis team Complete audit form before discharge and give to Trauma Scheduler for analysis by Audit Lead Page 4 of 12
4. Education and Training Training on use of the guideline will comprise awareness training, including awareness of thrombotic risk assessment and perioperative management of anticoagulated patients, and training for audit data collection. 5. Monitoring and Audit Criteria Data to be collected according to audit tool in appendix 3. 6. Legal Liability Guideline Statement See section 6.4 of the UHL Policy for Policies for details of the Trust Legal Liability statement for Guidance documents 7. Supporting Documents and Key References If applicable 8. Key Words DOAC, NOAC, Rivaroxaban, Apixaban, Dabigatran, Praxbind, Idarucizumab Page 5 of 12
Appendix 1 Risk of thrombo-embolism risk assessment tool: NON-VALVULAR ATRIAL FIBRILLATION VENOUS THROMBO- EMBOLISM (DVT/PE) MECHANICAL PROSTHETIC HEART VALVE OTHER DISCUSS WITH HAEMATOLOGY (HIGH RISK) 1. Previous TIA/stroke HIGH THROMBOEMBOLIC RISK (BRIDGING WITH THERAPEUTIC ANTICOAGULATION REQUIRED) 2. CHA 2 DS 2 VASC* 6 DVT or PE < 3 months. DVT/PE with target INR 3.0-4.0 Antiphospholipid syndrome All Mitral Aortic + risk factors* *atrial fibrillation, CCF, age > 75y, diabetes, increased fibrinogen levels, LV dysfunction, left atrial dilatation (diameter >50mm Atrial fibrillation with mitral stenosis Antiphospholipid syndrome Antithrombin deficiency History of Heparin induced thrombocytopenia (HIT) or Heparin allergy LOW THROMBOEMBOLIC RISK (PROPHYLACTIC LMWH REQUIRED ONLY FOR VTE THROMBOPROHYLAXIS AS NEEDED) 1.No previous TIA/Stroke 2. CHA 2 DS 2 VASC* < 6 DVT or PE > 3 months Aortic: no cardiovascular risk factors Page 6 of 12
Stroke risk stratification in Atrial Fibrillation: CHA 2 DS 2 VASC Appendix 2 Use this risk calculator for patients with atrial fibrillation to estimate cardioembolic risk RISK FACTOR CHA 2 DS 2 VASC SCORE Congestive heart failure 1 Hypertension 1 Age 65-74 1 Diabetes mellitus 1 Stroke/TIA/systemic 2 thromboembolism Vascular disease 1 Age 75 2 Sex Category (Female) 1 Page 7 of 12
Appendix3. Audit Data Collection DOAC AUDIT TOOL S number Time / Date of arrival (or referral if in-patient) DOAC / Indication Dose / time of last dose Praxbind yes / no / time DOAC levels yes / no / time / results / action Time to theatre Tranexamic Acid y / n / time / dose Estimated intraoperative blood loss Transfusion during admission yes / no / time / amount Reasons for delay to theatre > 36 hours Comments Page 8 of 12
This table is used to track the development and approval and dissemination of the document and any changes made on revised / reviewed versions Author / Lead Officer: Reviewed by: Approved by: Date DEVELOPMENT AND APPROVAL RECORD FOR THIS DOCUMENT Dorothea Morfey Job Title: Consultant Anaesthetist MSS Quality and Safety Board Issue Number Reviewed By REVIEW RECORD Date Approved: December 2016 Description Of Changes (If Any) DISTRIBUTION RECORD: Date Name Dept Received Page 9 of 12
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