title: Reversal of coagulopathy using prothrombin complex concentrates is associated with improved outcome compared to fresh frozen plasma in warfarin-associated intracranial hemorrhage.
abstract: BACKGROUND
  There are no studies demonstrating that prothrombin complex concentrates (PCC) improves outcome compared FFP in patients with warfarin-associated intracranial hemorrhage.
  
  
  METHODS
  A prospective, observational study was conducted of patients who received PCC (Bebulin VH), FFP, or PCC + FFP. All groups received vitamin K 10 mg IV. INR reversal (<1.4), adverse events (venous thromboembolism, myocardial infraction, pulmonary edema), major hemorrhage (new or worsened intracranial hemorrhage, anemia requiring transfusion or GI bleed), and 3-month functional outcome were compared between the groups using Chi squared and logistic regression analysis.
  
  
  RESULTS
  Of 64 patients, PCC alone was used in 16 (mean dose 48 IU/kg), FFP alone in 25 (mean dose 12.5 ml/kg), and PCC + FFP in 23 (median doses 47.4 IU/kg and 11.4 ml/kg, respectively). INR correction occurred in 88, 84, and 70 %, respectively. There were no differences in time to INR correction or adverse events between the groups, but FFP alone was associated with more major hemorrhage after administration (52 %, OR 5.0, 95 % CI 1.6-15.4, P = 0.006) and PCC with less (6 %, OR 0.1, 95 % CI 0.01-0.8, P = 0.033). After adjusting for age, admission GCS, initial INR, and bleed type, the use of PCC was associated with a lower risk of death or severe disability at 3-months (adjusted OR 0.02, 95 % CI 0.001-0.8, P = 0.039), while FFP alone was associated with a higher risk (adjusted OR 51.6, 95 % CI 1.2-2163.1, P = 0.039).
  
  
  CONCLUSIONS
  PCC adequately corrected INR without any increase in adverse events compared to FFP and was associated with less major hemorrhage and improved 3-month outcomes in patients with warfarin-associated intracranial hemorrhage.
authors.affiliation: Cerebrovascular Center of the Neurological Institute, Cleveland Clinic Foundation, 9500 Euclid Ave. S80, Cleveland, OH, 44195, USA, frontej@ccf.org.
authors.forename: Jennifer A
authors.initials: JA
authors.lastname: Frontera
authors.forename: Errol
authors.initials: E
authors.lastname: Gordon
authors.forename: Victor
authors.initials: V
authors.lastname: Zach
authors.forename: Maximo
authors.initials: M
authors.lastname: Jovine
authors.forename: Ken
authors.initials: K
authors.lastname: Uchino
authors.forename: Muhammad S
authors.initials: MS
authors.lastname: Hussain
authors.forename: Louis
authors.initials: L
authors.lastname: Aledort
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000009:adverse effects*; D000933:Antifibrinolytic Agents / Q000627:therapeutic use; D001778:Blood Coagulation Disorders / Q000139:chemically induced / Q000150:complications / Q000628:therapy*; D001779:Blood Coagulation Factors / Q000627:therapeutic use*; D016913:Blood Component Transfusion / Q000379:methods*; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D019934:International Normalized Ratio; D020300:Intracranial Hemorrhages / Q000139:chemically induced* / Q000209:etiology; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010949:Plasma; D011446:Prospective Studies; D016896:Treatment Outcome; D014812:Vitamin K / Q000627:therapeutic use; D014859:Warfarin / Q000009:adverse effects*; D055815:Young Adult
chemical_list: D000925:Anticoagulants; D000933:Antifibrinolytic Agents; D001779:Blood Coagulation Factors; D014812:Vitamin K; C025667:prothrombin complex concentrates; D014859:Warfarin