title: Efficacy and tolerability of human fibrinogen concentrate administration to patients with acquired fibrinogen deficiency and active or in high-risk severe bleeding.
abstract: OBJECTIVE
  Fibrinogen deficiency is a cause for massive haemorrhage whose management in emergency situations is the subject of debate. Plasma-derived fibrinogen concentrates are indicated for reversing the haemorrhagic diathesis found in congenital and acquired deficiencies.
  
  
  METHODS
  We report on the results of an observational study that evaluated the effects of fibrinogen concentrates in patients suffering from various forms of acquired severe hypofibrinogenaemia with life-threatening consumptive thrombo-haemorrhagic disorders (surgery, trauma and digestive haemorrhage), or underlying disease states that limit fibrinogen synthesis (hepatic dysfunction, haematological malignancies).
  
  
  RESULTS
  Sixty-nine patients were identified and included, in whom most of the processes (62%) corresponded to consumptive hypofibrinogenaemia. After a median dose of 4 g, a mean absolute increase of 1.09 g/l in plasma fibrinogen was measured and coagulation parameters were significantly improved (P < 0.001). Mortality rates of 32.3% and 44.2% were reported after 24 h and 72 h, respectively.
  
  
  CONCLUSIONS
  We conclude that the administration of fibrinogen concentrates in unresponsive, life-threatening haemorrhage with acquired hypofibrinogenaemia improves laboratory measures of coagulation, and may also be life saving. Although observational in nature, our data indicate a direct relationship between plasma fibrinogen levels and survival in acquired fibrinogen deficiency. Further studies are warranted to ascertain a clear relationship between fibrinogen levels and survival.
authors.affiliation: Pharmacy Service.
authors.forename: A Farriols
authors.initials: AF
authors.lastname: Danés
authors.affiliation: Haematology Service, Hospital Universitario Vall d'Hebron, Barcelona, Spain.
authors.forename: L Gallur
authors.initials: LG
authors.lastname: Cuenca
authors.affiliation: Haematology Service, Hospital Universitario Vall d'Hebron, Barcelona, Spain.
authors.forename: S Rodríguez
authors.initials: SR
authors.lastname: Bueno
authors.affiliation: Pharmacy Service.
authors.forename: L
authors.initials: L
authors.lastname: Mendarte Barrenechea
authors.affiliation: Pharmacy Service.
authors.forename: J Bruno Montoro
authors.initials: JBM
authors.lastname: Ronsano
mesh_terms: D000293:Adolescent; D000328:Adult; D000347:Afibrinogenemia / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D004361:Drug Tolerance; D005260:Female; D005340:Fibrinogen / Q000008:administration & dosage* / Q000009:adverse effects / Q000302:isolation & purification; D006470:Hemorrhage / Q000097:blood / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012307:Risk Factors; D012449:Safety
chemical_list: D005340:Fibrinogen