Page 1 of 5 GUIDELINE STATEMENT Traumatic intracranial hemorrhage can have devastating complications, especially for those patients on prescribed anticoagulation therapy. Trauma patients who are receiving warfarin at the time of the injury are at increased risk for hemorrhagic complications and death. Rapid reversal of this anticoagulant may minimize these risks. The use of prothrombin complex concentrate (PCC) can quickly accelerate reversal of coagulopathy at a relatively low cost. Note: This medication is only to be ordered by a Trauma or Emergency Attending. GUIDELINE A. Patient Arrival: Patients arriving with a trauma mechanism, known or suspected head injury and a history of warfarin use they should be activated as a trauma consult. Goals: *if a reliable history is not available, coagulation studies will be obtained with initial trauma laboratory panel. 1. Head CT scan completed within 20 minutes of arrival 2. STAT INR/PT/PTT and fibrinogen 3. Type and Cross and Confirmatory blood tubes sent 4. Obtain GCS and vital signs at time of triage 5. Neuro checks hourly at least until the first repeat CT scan 6. Goal: Warfarin reversal of INR <1.5 within 2 hours for active bleeding B. If CT is positive for ICH or patient shows signs of significant bleeding 1. If INR < 1.9 a. Administer Vitamin K 10 mg IV, consider continuation b. Consider additional reversal treatment, such as FFP, per physician discretion c. Neurosurgery consult for ICH d. Admit patient to critical care area 2. If INR > 2.0 a. Administer Vitamin K 10 mg IV 1. Administer Kcentra (PCC) (round to the nearest vial size) INR 2-< 4 = 25 units/kg not to exceed 2500 units INR 4-6 = 35 units/kg not to exceed 3500 units INR > 6 = 50 units/kg not to exceed 5000 units b. Neurosurgery consult for ICH c. Admit to critical care area d. Re-check INR, PT/PTT and fibrinogen levels 30 minutes after infusions complete 1. If INR remains > 2.0 If fibrinogen < 100 consider administering 10 units of cryoprecipitate Re-check INR, PT/PTT and fibrinogen levels 30 minutes after infusions complete. Repeat head CT in 3 hours from initial CT scan 2. If INR is 1.9 Consider Vitamin K
Page 2 of 5 Repeat head CT in 3 hours from initial scan C. CT Negative for ICH or patient does not show signs of significant bleeding 1. If INR < 2.9 a. No reversal required b. If there is a need for therapeutic INR: reassess and continue warfarin c. Discharge from ED with appropriate instructions 2. If INR >3.0 a. Admit and observe for 6 hours post injury with hourly neuro checks b. Rescan prior to discharge c. If there is a need for therapeutic INR: reassess and continue warfarin d. Discharge from hospital with appropriate instructions
Page 3 of 5 History of Warfarin Use AND Trauma Mechanism, Known or Suspected Head Injury CT positive or Significant bleeding NS Consult DC Warfarin, Trauma consult, STAT: INR/PT/PTT, Fibrinogen, Type/Cross Head CT: within 20 minutes of arrival, Obtain GCS and vital signs at time of triage Neuro checks: hourly; at least until the first repeat CT scan. GOAL: Reversal of INR <1.5 within 2 hours for active bleeding CT negative or No significant bleeding INR < 1.9 INR 2.0 INR < 2.9 INR > 3.0 Vitamin K 10mg IV Consider additional treatment options per MD discretion Consider Vitamin K 10 mg IV every 8 hours Vitamin K10 mg IV; Kcentra per INR based dosing Recheck INR, PT/PTT & Fibrinogen 30 minutes after infusion INR < 1.9 INR 2.0 No reversal required If fibrinogen < 100 10 units consider Cryoprecipitate Need for therapeutic INR: reassess & continue warfarin. DC from ED Admit and observe for 6 hours post injury, hourly neuro s and re-scan prior to DC Need for therapeutic INR: reassess & continue warfarin. Repeat CT Head Note: in The 3 University of Kansas Hospital policies are maintained Recheck electronically INR, PT/PTT and are subject & Fibrinogen to change. 30 Printed minutes copies after may not hours from initial scan infusion; Repeat Head CT
Page 4 of 5 REFERENCES: 1. Sarode R., et al. Rapid warfarin reversal: a 3-factor prothrombin complex concentrate and recombinant factor VIIa cocktail for intracerebral hemorrhage. J Neurosurg.2012;116:491-497. 2. Franchini M., Lippi G. Prothrombin Complex Concentrates: an update. Blood Transfusions.2010;8:149-154. 3. Kalin M., et al. A Protocol for the Rapid Normalization of INR in Trauma Patients with Intracranial Hemorrhage on Prescribed Warfarin Therapy. The American Surgeon.2008;74:858-861. 4. Goodnough L.T. and Shander A., How I Treat warfarin-associated Coagulopathy in patients with intracerebral hemorrhage. Blood Journal.2011;117:6091-6099. 5. Ivascu F.A., et al. Rapid Warfarin Reversal in Anticoagulated Patients with Traumatic Intracranial Hemorrhage Reduces Hemorrhage Progression and Mortality. J Trauma. 2005; 59: 1131-1139. 6. Holland L, et al. Suboptimal effect of a three-factor prothrombin complex concentrate (Profilnine- SD) in correcting supratherapeutic international normalized ratio due to warfarin overdose. Transfusion. 2009;49:1171-1177. 7. Chong CT, et al. Rapid reversal of coagulopathy in warfarin-related intracranial haemorrhages with prothrombin complex concentrates. Anesthesia and Intensive Care. 2010;38(3):474-480. 8. Chapman SA, et al. Prothrombin Complex Concentrate Versus Standard Therapies for INR Reversal in Trauma Patients Receiving Warfarin. The Ann Pharmacother. 2011;45:869-875. 9. Calland J.F., et al. Evaluation and management of geriatric trauma: An Eastern Association for the Surgery of Trauma practice management guideline. J Trauma Acute Care Surg. 2012:73(5):345-350. 10. Barbosa R.R., et al. Evaluation and management of mild traumatic brain injury: An Eastern Association for the Surgery of Trauma practice management guideline. J Trauma Acute Care Surgery.2012: 75(5):307-314. 11. Reynolds F.D., et al. Time to Deterioration of the Elderly, Anticoagulated, Minor Head Injury Patient Who Presents without Evidence of Neurologic Abnormality. The Journal of Trauma Injury, Infection and Critical Care. 2003: 492-496. 12. Zareh, Meena, et al. (2011). Reversal of Warfarin-Induced Hemorrhage in the Emergency Department. Western Journal of Emergency Medicine. 12(4). 386-392. 13. Hanke, A.A., Joch, C., Gorlinger, K. (2013). Long-term safety and efficacy of pasteurized nanofiltrated prothrombin complex concentrate (Beriplex P/N): a pharmacovigilance study. British Journal of Anesthesia. 110(5).764-772. 14. Makris, Mike, Veen, Joost J. (2011). Three or four factor prothrombin complex concentrate for emergency anticoagulation reversal? Blood Transfus. 9:117-119. 15. Wong, Yun. (2011). Use of Prothrombin Complex Concentrate for Vitamin K Antagonist Reversal before Surgical Treatment of Intracranial Hemorrhage. Clinical Medicine Insights: Case Reports. 4:1-6.
Page 5 of 5 16. Pabinger, Ingrid, et al. (2010). Impact of infusion speed on the safety and effectiveness of prothrombin complex concentrate: A prospective clinical trial of emergency anticoagulation reversal. Ann Hematol. 8:309-316. 17. Sarode, R., et al. Efficacy and Safety of a Four-Factor Prothrombin Complex Concentrate (4F- PCC) in Patients on Vitamin K Antagonists Presenting with Major Bleeding: A Randomized, Plasma Controlled, Phase IIIb Study. Circulation. REVIEWED BY: TRAUMA ATTENDING MEETING; APRIL, 2013 ED ATTENDING MEETING; APRIL, 2013 CRITICAL CARE COMMITTEE; APRIL, 2013 TRAUMA SYSTEMS; APRIL, 2013 NEUROSURGERY ATTENDING MEETING; APRIL, 2013 BLOOD UTILIZATION COMMITTEE; JUNE, 2013 PHARMACY AND THERAPEUTICS; SEPTEMBER, 2013 KEYWORDS: Head Injury, Trauma, Warfarin, Brain Hemorrhage