Ann Lab Med.  2012 Mar;32(2):145-152. 10.3343/alm.2012.32.2.145.

Evaluation of Recombinant Factor VIIa Treatment for Massive Hemorrhage in Patients with Multiple Traumas

• Koh YR
• Cho SJ
• Yeom SR
• Chang CL
• Lee EY
• Son HC
• Kim HH

• KMID: 1245255
• DOI: http://doi.org/10.3343/alm.2012.32.2.145

Abstract

BACKGROUND
Recent studies and case reports have shown that recombinant factor VIIa (rFVIIa) treatment is effective for reversing coagulopathy and reducing blood transfusion requirements in trauma patients with life-threatening hemorrhage. The purpose of this study is to evaluate the effect of rFVIIa treatment on clinical outcomes and cost effectiveness in trauma patients.
METHODS
Between January 2007 and December 2010, we reviewed the medical records of patients who were treated with rFVIIa (N=18) or without rFVIIa (N=36) for life-threatening hemorrhage due to multiple traumas at the Emergency Department of Pusan National University Hospital in Busan, Korea. We reviewed patient demographics, baseline characteristics, initial vital signs, laboratory test results, and number of units transfused, and then analyzed clinical outcomes and 24-hr and 30-day mortality rates. Thromboembolic events were monitored in all patients. Transfusion costs and hospital stay costs were also calculated.
RESULTS
In the rFVIIa-treated group, laboratory test results and clinical outcomes improved, and the 24-hr mortality rate decreased compared to that in the untreated group; however, 30-day mortality rate did not differ between the groups. Thromboembolic events did not occur in both groups. Transfusion and hospital stay costs in the rFVIIa-treated group were cost effective; however, total treatment costs, including the cost of rFVIIa, were not cost effective.
CONCLUSIONS
In our study, rFVIIa treatment was shown to be helpful as a supplementary drug to improve clinical outcomes and reduce the 24-hr mortality rate, transfusion and hospital stay costs, and transfusion requirements in trauma patients with life-threatening hemorrhage.

Keyword

Recombinant factor VIIa; Multiple trauma; Clinical outcome; Mortality rate; Treatment cost

MeSH Terms

Adult
Aged
Aged, 80 and over
Factor VIIa/*therapeutic use
Hemoglobins/analysis
Hemorrhage/complications/*drug therapy/mortality
Humans
Middle Aged
Multiple Trauma/*complications
Partial Thromboplastin Time
Platelet Count
Prothrombin Time
Recombinant Proteins/therapeutic use
Retrospective Studies
Treatment Outcome

Figure

• 

  Fig. 1 Transfusion volume (units) of pRBCs (P<0.0001), FFP (P<0.0001), and PLT concentrate (P=0.0085) before (pre) and after (post) rFVIIa administration within the first 24 hr of hospital admission in the 18 rFVIIa-treated patients. Data are presented as box plots with median lines. Abbreviations: RBC, red blood cells; FFP, fresh frozen plasma; PLT, platelet concentrates; rFVIIa, recombinant activated factor VII.

• 

  Fig. 2 Changes in mean (A) hemoglobin, (B) platelet count, (C) PT, and (D) aPTT after rFVIIa administration in the rFVIIa-treated group (N=18, straight lines) and within the first 24 hr of admission in the rFVIIa-untreated group (N=36, dotted lines). Abbreviations: PT, prothrombin time; aPTT, activated partial thromboplastin time; rFVIIa, recombinant activated factor VII.

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