title: Prothrombin complex concentrate (Octaplex):  a Portuguese experience in 1152 patients.
abstract: In emergency/clinical practice it is often necessary to restore the balance of blood coagulation: the rapid reversal of oral anticoagulant therapy (OAT) is crucial in cases of serious acute bleeding and emergency surgery in patients with high international normalized ratios (INRs). Coagulation can be normalized via the application of haemostatic products, including fresh frozen plasma (FFP) or prothrombin complex concentrates (PCCs). Guidelines recommend PCCs for the reversal of OAT in preference to FFP in patients with major/life-threatening bleeding and high INRs. Advantages of PCCs include: minimal disruption to haemostasis, rapid administration and fast onset of action. One such PCC is Octaplex which is available in many countries, including Portugal. The aim of this retrospective, observational, multicentre study was to assess the clinical applications and efficacy (via reduction in INR after treatment) of Octaplex. Over the 4-year study period, 1194 infusions of Octaplex were administered in 1152 patients (69.2% for reversal of OAT, 17.3% for liver dysfunction, 10.2% for uncontrolled bleeding). The mean patient age was 64 years and the mean dose of Octaplex was 20.37 ± 7.00 IU/kg. Overall, Octaplex treatment was associated with a significant reduction in INR (P < 0.0001). In 95% of all treatment episodes, only one dose of Octaplex was required. No adverse drug reactions or thromboembolic events were reported. Octaplex effectively and significantly reduces INR values in patients requiring the restoration of blood coagulation. It effectively reverses the effect of OAT and was efficacious in the majority of bleeding episodes in patients with liver dysfunction.
authors.affiliation: Centro Hospitalar São João, Hospital São João, E.P.E., Portugal. carvalho.mmanuela@gmail.com
authors.forename: Manuela C
authors.initials: MC
authors.lastname: Carvalho
authors.forename: Anabela G
authors.initials: AG
authors.lastname: Rodrigues
authors.forename: Luísa M
authors.initials: LM
authors.lastname: Conceição
authors.forename: Miguel L
authors.initials: ML
authors.lastname: Galvão
authors.forename: Luis C
authors.initials: LC
authors.lastname: Ribeiro
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage; D001777:Blood Coagulation; D001779:Blood Coagulation Factors / Q000008:administration & dosage / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004334:Drug Administration Schedule; D005260:Female; D006470:Hemorrhage / Q000097:blood / Q000188:drug therapy*; D006490:Hemostatics / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007223:Infant; D019934:International Normalized Ratio; D008107:Liver Diseases / Q000097:blood*; D008297:Male; D008875:Middle Aged; D019370:Observation; D011174:Portugal; D012189:Retrospective Studies
chemical_list: D000925:Anticoagulants; D001779:Blood Coagulation Factors; D006490:Hemostatics; C025667:prothrombin complex concentrates