title: Administration of fibrinogen concentrate for refractory bleeding in massively transfused, non-trauma patients with coagulopathy: a retrospective study with comparator group.
abstract: BACKGROUND
  This retrospective, single centre study was conducted to investigate the efficacy of fibrinogen concentrate (FBNc) in decreasing blood requirements and reaching optimal fibrinogen level, in non-trauma, massively transfused, bleeding patients with coagulopathy.
  
  
  METHODS
  Over a 3-years period, all patients for whom a massive transfusion protocol was activated and had received ≥ 4 units of allogeneic blood components within a ≤ 4 h period, were included. Patients were classified according to whether they received FBNc or achieved an optimal fibrinogen level of ≥ 2 g/L within 24 h after FBNc administration.
  
  
  RESULTS
  Seventy-one patients received 2 [2,4] g of FBNc (FBNc group) and 72 did not (comparator group). FBNc was administered after transfusing 5 [5,9] blood component units, 3 [2,6] hours after massive transfusion protocol activation. Linear regression analysis showed that SOFA (AOR 0.75 [95% CI:0.08-1.43]) and admission fibrinogen level (AOR -2.7 [95% CI:-4.68 - -0.78]), but not FBNc administration, were independently associated with total transfused units. There was a significant inverse relation between both admission and target fibrinogen levels, and total transfused components. Logistic regression showed a direct relationship between admission fibrinogen level and achieving a target level ≥ 2 g/L (AOR 3.29 [95% CI;1.95-5.56]). No thromboembolic events associated with FBNc were observed.
  
  
  CONCLUSIONS
  In massively transfused, non-trauma patients with coagulopathy and refractory bleeding, late administration of low FBNc dosage was not associated with decreased blood transfusion or increased post-infusion fibrinogen level. Given that both fibrinogen upon admission and target fibrinogen levels were associated with decreased blood transfusion, earlier administration and higher doses of FBNc could be needed.
authors.affiliation: Critical Care Division, Hospital Universitario "Virgen del Rocío" and Instituto de Biomedicina IBIS, Avenida Manuel Siurot s/n, 41013 Seville, Spain.
authors.forename: Santiago R
authors.initials: SR
authors.lastname: Leal-Noval
authors.affiliation: Critical Care Division, Hospital Universitario "Virgen del Rocío" and Instituto de Biomedicina IBIS, Avenida Manuel Siurot s/n, 41013 Seville, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Casado
authors.affiliation: Critical Care Division, Hospital Universitario "Virgen del Rocío" and Instituto de Biomedicina IBIS, Avenida Manuel Siurot s/n, 41013 Seville, Spain.
authors.forename: Victoria
authors.initials: V
authors.lastname: Arellano-Orden
authors.affiliation: Critical Care Division, Hospital Universitario "Virgen del Rocío" and Instituto de Biomedicina IBIS, Avenida Manuel Siurot s/n, 41013 Seville, Spain.
authors.forename: Reginald
authors.initials: R
authors.lastname: Dusseck
authors.affiliation: Pharmacy Division, Hospital Universitario "Virgen del Rocío" and Instituto de Biomedicina IBIS, Avenida Manuel Siurot s/n, 41013 Seville, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Bautista-Paloma
authors.affiliation: Transfusion Medicine, University of Málaga, Málaga, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Muñoz
authors.affiliation: Critical Care Division, Hospital Universitario "Virgen del Rocío" and Instituto de Biomedicina IBIS, Avenida Manuel Siurot s/n, 41013 Seville, Spain.
authors.forename: José
authors.initials: J
authors.lastname: Naranjo-Izorieta
authors.affiliation: Critical Care Division, Hospital Universitario "Virgen del Rocío" and Instituto de Biomedicina IBIS, Avenida Manuel Siurot s/n, 41013 Seville, Spain.
authors.forename: Antonio Puppo
authors.initials: AP
authors.lastname: Moreno
authors.affiliation: Statistics and Design Division, Hospital del Valme, Seville, Spain.
authors.forename: Aurelio
authors.initials: A
authors.lastname: Cayuela
mesh_terms: D000328:Adult; D000368:Aged; D001778:Blood Coagulation Disorders / Q000628:therapy*; D001803:Blood Transfusion / Q000379:methods*; D003029:Coagulants / Q000008:administration & dosage / Q000627:therapeutic use; D005260:Female; D005340:Fibrinogen / Q000008:administration & dosage / Q000627:therapeutic use*; D006470:Hemorrhage / Q000628:therapy*; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D003029:Coagulants; D005340:Fibrinogen
keywords: Anaemia; Bleeding; Clauss method; FIBTEM; Fibrinogen concentrate; Goal directed therapy; Massive transfusion protocol; ROTEM; TEG; Thromboelastography; Thromboelastometry; Transfusion