title: Recombinant activated factor VII (NovoSeven): addition to replacement therapy in acute, uncontrolled and life-threatening bleeding.
abstract: OBJECTIVE
  Recombinant activated factor VII (rFVIIa, NovoSeven) has been used off-label for various conditions. A protocol for its use in acute, uncontrolled life-threatening bleeding, was devised and employed. A haematologist/transfusion specialist was assigned as a member of the team.
  
  
  METHODS
  The clinical data were reviewed and summarized. A scoring system for the assessment and monitoring of coagulopathy was employed. Each parameter of prothrombin time (PT), activated partial thromboplastin time (aPTT), platelet number and fibrinogen level was allocated points according to the degree of abnormality. Three scoring levels emerged.
  
  
  RESULTS
  Between April 2001 and April 2003, 13 patients received rFVIIa for acute, uncontrolled life-threatening bleeding. Nine of 13 patients remained alive for 15 days or longer after rFVIIa infusion. All patients who experienced a reduction or cessation of bleeding after rFVIIa infusion, also had a lower coagulopathy score after replacement therapy, prior to rFVIIa infusion, compared with their score at rFVIIa request. There was a reduction in the average use of blood products after rFVIIa infusion. The coagulopathy score was statistically predictive of response to rFVIIa and survival.
  
  
  CONCLUSIONS
  In an area where very little data exists, we report the usefulness of rFVIIa. We propose that transfusion replacement should aim to correct coagulopathy before infusion of rFVIIa and that a haematologist/transfusion specialist should be involved in the management of these patients. A prognostically significant coagulopathy scoring system is offered.
authors.affiliation: Department of Surgery B, Sourasky Tel-Aviv Medical Center, Tel-Aviv, Israel.
authors.forename: A
authors.initials: A
authors.lastname: Mayo
authors.forename: M
authors.initials: M
authors.lastname: Misgav
authors.forename: Y
authors.initials: Y
authors.lastname: Kluger
authors.forename: R
authors.initials: R
authors.lastname: Geenberg
authors.forename: D
authors.initials: D
authors.lastname: Pauzner
authors.forename: J
authors.initials: J
authors.lastname: Klausner
authors.forename: O
authors.initials: O
authors.lastname: Ben-Tal
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000368:Aged; D001778:Blood Coagulation Disorders / Q000150:complications; D001780:Blood Coagulation Tests; D016063:Blood Loss, Surgical; D001803:Blood Transfusion; D003131:Combined Modality Therapy; D004630:Emergencies; D005167:Factor VII / Q000627:therapeutic use*; D015942:Factor VIIa; D005260:Female; D006405:Hematology; D006470:Hemorrhage / Q000188:drug therapy* / Q000209:etiology / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D010348:Patient Care Team; D019106:Postoperative Hemorrhage / Q000188:drug therapy / Q000628:therapy; D011247:Pregnancy; D011249:Pregnancy Complications, Cardiovascular / Q000188:drug therapy / Q000628:therapy; D011994:Recombinant Proteins / Q000627:therapeutic use*; D012189:Retrospective Studies; D012720:Severity of Illness Index; D014592:Uterine Hemorrhage / Q000188:drug therapy / Q000628:therapy; D014947:Wounds and Injuries / Q000150:complications
chemical_list: D011994:Recombinant Proteins; D005167:Factor VII; C103587:recombinant FVIIa; D015942:Factor VIIa