Document Detail


Low-dose recombinant factor VIIa for trauma patients with coagulopathy.
MedLine Citation:
PMID:  18656871     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
INTRODUCTION: Coagulopathy in injured patients is common and is generally treated with fresh frozen plasma (FFP). Response can be variable, thus complete correction may take hours and require large volumes of fluids. High-dose recombinant factor VIIa (FVIIa, Novoseven, Novo Nordisk, Bagsvaerd, Denmark) has been used off-label to treat severe coagulopathy following trauma. Expense has limited use. Recently, we began administering low dose FVIIa (1.2mg) to patients with mild to moderate coagulopathy after trauma, hypothetising that it would be effective and safe. PATIENTS AND METHODS: We retrospectively reviewed consecutive patients who received a low dose of 1.2mg of FVIIa over a 2-year period. Factor VIIa is administered after approval by a gatekeeper at the discretion of the treating physician. Demographics, injury and laboratory data were abstracted as were indications for use, source of coagulopathy, effectiveness, and complications. A two-tailed paired t-test was used to determine significant changes in coagulation parameters and blood product utilisation. RESULTS: Eighty-one patients received 84 low doses of FVIIa. The mean age of the patients was 51 (+/-22) with a mean ISS of 29 (+/-11). Seventy-three per cent were male and 67% had a traumatic brain injury (TBI) as their primary injury. The aetiology of the coagulopathy in the study population included; TBI (40%), warfarin use (22%), and cirrhosis (13%). Mean prothrombin time (PT) fell from 17.0 s (+/-3.2) to 10.6s (+/-1.4) (p<0.0001). All patients had a good clinical response with no bleeding complications. Utilisation of packed red blood cells and fresh frozen plasma were significantly less in the 24h after FVIIa administration as compared to the 24h prior. Subsequent thromboembolic events were observed in 12 of the 81 patients (15%) and included; cerebrovascular accident (CVA) (6), mesenteric thrombosis (2), myocardial infarction (MI) (1), pulmonary embolism/deep venous thrombosis (PE/DVT) (2), and atrial thrombus (1). Only four of these events were thought to be related to the FVIIa administration, with two of the four contributing to a lethal outcome. CONCLUSIONS: Low dose FVIIa rapidly and effectively treats mild to moderate coagulopathy following injury. This low dose (1.2mg) FVIIa is the smallest available unit dose. It costs approximately the same as 8 units of plasma and may be cost-effective in patients who require high volume factor administration. Low dose FVIIa may be effective in coagulopathic trauma patients who are not in shock but require rapid normalisation of clotting function.
Authors:
Deborah M Stein; Richard P Dutton; John R Hess; Thomas M Scalea
Publication Detail:
Type:  Journal Article     Date:  2008-07-25
Journal Detail:
Title:  Injury     Volume:  39     ISSN:  1879-0267     ISO Abbreviation:  Injury     Publication Date:  2008 Sep 
Date Detail:
Created Date:  2008-08-11     Completed Date:  2009-04-06     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0226040     Medline TA:  Injury     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  1054-61     Citation Subset:  IM    
Affiliation:
R Adams Cowley Shock Trauma Centress, Program in Trauma, University of Maryland School of Medicine, Baltimore, MD 21201, USA. dstein@umm.edu
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MeSH Terms
Descriptor/Qualifier:
Adult
Aged
Blood Coagulation Disorders / drug therapy*,  etiology
Cohort Studies
Factor VIIa / administration & dosage,  therapeutic use*
Female
Humans
Male
Middle Aged
Recombinant Proteins / administration & dosage,  therapeutic use
Retrospective Studies
Wounds and Injuries / drug therapy*
Chemical
Reg. No./Substance:
0/Recombinant Proteins; 0/recombinant FVIIa; EC 3.4.21.21/Factor VIIa

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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