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CLINICAL PROTOCOL

Subject: Page Protocol # EMERGENT TREATMENT OF PATIENTS WITH AND 1 of 4 NMH CCP 07.0016 CLOTTING EMERGENCIES WHO ARE TAKING NOVEL ORAL Version: 1.0 Title: Revision of: Effective Date: EMERGENT TREATMENT OF PATIENTS WITH BLEEDING AND NEW 01/29/2013 CLOTTING EMERGENCIES WHO ARE TAKING NOVEL ORAL Removal Date: RIVAROXABAN (XARELTO)

I. PURPOSE: To standardize management of patients with bleeding and clotting emergencies who are taking novel oral anticoagulants (NOACs). This protocol covers emergent reversal and ischemic in patients on rivaroxaban (Xarelto) therapy.

II. CLINICAL PROTOCOL: A. The NOAC rivaroxaban (Xarelto) are increasingly in use for stroke prevention in patients with . This agent presents clinicians with several challenges, because there are no specific antidotes, and no readily available quantitative assay to determine the degree of anticoagulation in a patient on this therapy. B. Patients taking this agent are likely to present to the hospital with; 1. life-threatening bleeding (e.g., intracerebral hemorrhage or GI bleeding), or a need for an emergent invasive procedure (surgery, cardiac Catherization) 2. acute ischemic stroke. The administration of tissue (IV tPA) in the setting of NOAC use is potentially dangerous. C. There are no accepted, evidence-based guidelines for managing these situations. This protocol is a consensus of clinicians from stroke neurology, neurosurgery, hematology, neurocritical care, laboratory medicine, cardiology, and pharmacy.

III. REVERSAL PROTOCOL FOR PATIENTS WITH SEVERE/LIFE-THREATENING BLEEDING TAKING RIVAROXABAN (XARELTO): A. Inclusion criteria: 1. Patient has taken anticoagulant dose of rivaroxaban (20 mg, or 15 mg in setting of renal insufficiency) within last 48 hours. a. If time of last dose is unknown, but patient is suspected of having taken rivaroxaban (doses as above) in last 48 hours, and PT is abnormal and 2. Patient has clinically significant acute intracranial or intraspinal hemorrhage, and/or 3. Any life threatening bleeding (including surgical or traumatic) in which emergent reversal of coagulopathy is necessary, and/or Title: Page Protocol # NMH CCP 07.0016 TREATMENT OF PATIENTS WITH BLEEDING AND CLOTTING 2 of 4 Version: 1.0 EMERGENCIES WHO ARE TAKING NOVEL ORAL ANTICOAGULANTS RIVAROXABAN (XARELTO)

4. Any other situation (e.g. need for emergent invasive procedure) in which emergent reversal of coagulopathy is necessary. B. Exclusion Criteria: Allergy to FEIBA (Factor Eight Inhibitor Bypass Agent) C. Procedure for Rivaroxaban (Xarelto) Reversal 1. Discontinue all anticoagulants and anti- therapies 2. Support vital functions as per routine protocols 3. Send PT “super stat”; (and send rivaroxaban-specific anti-Factor Xa level, which takes days, do not wait for results). 4. Do not follow INR; it is less reliable than PT. 5. Do not wait for results if time of last dose is known (refer to Inclusion 1.). 6. If time of last dose is within 12 hours order 100 IU/kg of FEIBA x 1. a. Consider activated charcoal administration 7. If time of last dose is unknown or greater than 12 hours order 50 IU/kg FEIBA x 1. 8. Call Pharmacy and alert them that FEIBA is being ordered for life threatening rivaroxaban coagulopathy and is needed immediately. 9. Infuse FEIBA 10. After 1 hour, redraw PT and Factor Xa level to document reversal of coagulopathy. 11. Stat consult to Hematology. 12. If uncontrolled bleeding continues, consider repeat FEIBA dosing, in consultation with Hematology. 13. Patient should be moved to an ICU, but do not delay FEIBA infusion for ICU transfer. 14. Rivaroxaban is not dialyzable.

IV. INTRAVENOUS FOR ACUTE ISCHEMIC STROKE IN PATIENTS TAKING OR SUSPECTED OF TAKING RIVAROXABAN (XARELTO): A. Principle: No IV thrombolysis if clinically meaningful effect of the drug may be present. B. All standard inclusion/exclusion criteria apply (for 0-3 hours, or 3 – 4.5 hours windows, as appropriate). C. For patients taking or suspected of taking Rivaroxaban (20 mg, or 15 mg if Cr Cl is less than 30): 1. If last dose has been taken within 48 hours, do not administer IV tPA (regardless of laboratory results). a. If last dose unknown, draw PT “super stat” and wait for results. b. If PT is abnormal, do not administer IV tPA. Title: Page Protocol # NMH CCP 07.0016 TREATMENT OF PATIENTS WITH BLEEDING AND CLOTTING 3 of 4 Version: 1.0 EMERGENCIES WHO ARE TAKING NOVEL ORAL ANTICOAGULANTS RIVAROXABAN (XARELTO)

c. Consider intra-arterial therapies (mechanical, local thrombolysis) as appropriate. d. Do not administer FEIBA and then administer IV tPA; however, consider FEIBA prior to groin puncture if intra-arterial therapies are planned.

V. CLINICAL PROTOCOL UPDATE SCHEDULE: Every 2 years, or more often, as appropriate

VI. REFERENCES: Alberts, M.J., Bernstein, R.A., Naccarelli, J.V., Garcia, D. Using in Patients with Stroke: A practical guide for clinicians. Stroke (2011). 43(1): 271-9

VII. APPENDICES: None Title: Page Protocol # NMH CCP 07.0016 TREATMENT OF PATIENTS WITH BLEEDING AND CLOTTING 4 of 4 Version: 1.0 EMERGENCIES WHO ARE TAKING NOVEL ORAL ANTICOAGULANTS RIVAROXABAN (XARELTO)

VIII. APPROVAL:

Responsible Party: Richard A. Bernstein, M.D., Ph.D.

Director, Northwestern Memorial Hospital Stroke Service

Reviewers: Kimberly Levasseur, Pharm D. Pharmacy Brandon McMahon, M.D. (Hematology) Dan Fintel, M.D. (Cardiology) Rod Passman, M.D. (Cardiac Electrophysiology) Paul Lindholm, M.D. (Laboratory Medicine) Deborah Bergman, A.P.N., FNP (Stroke NP)

Bernard Bendok, M.D. (Neurosurgery)

Committees: Medication Safety Committee, May 14, 2012 Pharmacy and Therapeutics, May 17, 2012

Stroke Quality Committee: May 10, 2012 per Dr. Bernstein’s email.

Approval Party: Richard A. Bernstein, M.D., Ph.D. Director, Northwestern Memorial Hospital Stroke Service Electronic Approval: 09/23/2012

IX. REVIEW HISTORY: Written: 05/03/2012