Document Detail

The clinical and laboratory response to recombinant factor VIIA in trauma and surgical patients with acquired coagulopathy.
MedLine Citation:
PMID:  16843774     Owner:  NLM     Status:  MEDLINE    
OBJECTIVE: In bleeding patients who are coagulopathic, the clinical response to administration of recombinant factor VIIa (rFVIIa) relates to the changes in prothrombin time (PT). DESIGN: Retrospective review of all surgical and trauma patients who were coagulopathic and received factor VIIa at the authors' institution over the past 27 months. SETTING: Academic tertiary referral facility and level I trauma center. PARTICIPANTS: Eighteen patients met inclusion criteria, 10 trauma and 8 surgical. Mean age 50 years (range, 17-84). RESULTS: Overall mortality was 39%. All but 1 patient (17/18) had resolution of coagulopathic bleeding with rFVIIa, and all clinical responders (n = 17) (defined as clinical cessation of bleeding within 24 hours determined by either attending surgeon or chief resident progress note) had a decrease in PT to normal range. In contrast, the single clinical nonresponder had an insignificant PT decrease (19 to 18 seconds). Prothrombin time decreased from 20 +/- 4 seconds to 12 +/- 2 seconds, p < 0.05 (n = 17). International Normalized Ratio (INR) decreased from 1.59 to 0.86, p < 0.05 (n = 17). Fibrinogen before administration was 299.73 (range, 105-564) (n = 15). pH before administration was 7.25 (+/-0.18) (n = 10). Patient temperature was 98.64 (+/-2.06). Effect in partial thromboplastin time (PTT) was inconsistent (50 +/- 49 seconds to 34 +/- 6 seconds, p > 0.05). Transfusion requirements for red blood cells (14 to 3 units) and plasma (12 to 3 units) were significantly reduced after rFVIIa. There were no significant differences in percentage PT decrease between dose > or =100 mcg/kg vs <100 mcg/kg, surgical vs trauma patients, survivors vs nonsurvivors, and those with pretreatment platelet count > or =100 K vs <100 K. CONCLUSIONS: The administration of rFVIIa caused a decrease in the PT in nearly all patients. There were an insufficient number of patients to support the use of PT as a clinical predictor of response; however, the data are suggestive of such utility. If the PT does not correct, then it is likely that there is a deficiency of other factors of the coagulation cascade.
Neil R McMullin; David S Kauvar; Heather M Currier; Toney W Baskin; Anthony E Pusateri; John B Holcomb
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Current surgery     Volume:  63     ISSN:  0149-7944     ISO Abbreviation:  Curr Surg     Publication Date:    2006 Jul-Aug
Date Detail:
Created Date:  2006-07-17     Completed Date:  2006-12-22     Revised Date:  2008-11-21    
Medline Journal Info:
Nlm Unique ID:  7802123     Medline TA:  Curr Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  246-51     Citation Subset:  IM    
United States Army Institute of Surgical Research, Fort Sam Houston, TX 78234, USA.
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MeSH Terms
Blood Coagulation Disorders / drug therapy*,  etiology
Critical Illness / therapy*
Factor VII / administration & dosage,  therapeutic use*
Factor VIIa
Hemostatics / administration & dosage*
Middle Aged
Postoperative Period
Prothrombin Time
Recombinant Proteins / administration & dosage,  therapeutic use
Retrospective Studies
Surgical Procedures, Operative
Treatment Outcome
Wounds and Injuries / complications,  physiopathology*
Reg. No./Substance:
0/Hemostatics; 0/Recombinant Proteins; 0/recombinant FVIIa; 9001-25-6/Factor VII; EC VIIa

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

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