Recombinant activated factor VII in controlling bleeding in non-hemophiliac patients.
BACKGROUND
There have been recent reports on the successful use of recombinant factor VIIa (rFVIIa) in non-hemophiliac patients who have experienced heavy blood loss due to trauma with extensive organ damage and who have received multiple blood transfusions with hemostatic changes without success. The timing of administration, dosage, mortality, units of blood transfusion saved, risk of thrombotic events, and the risk/benefit ratio are still poorly defined.


METHODS
We conducted a retrospective review of all medical records of patients who received rFVIIa between January 2003 and March 2008. Data collection included demographic characteristics, diagnosis, indications, comorbidities, and amount of blood products used with rFVIIa, dose of rFVIIa, mortality, and adverse events.


RESULTS
We identified 45 patients, 27 (60%) males and 18 (40%) females, with a median age of 52 years. The median dose of rFVIIa was 40 microg/kg (range, 20-120 microg/kg). Five (11.1%) patients needed a second dose of rFVIIa (dose range of 20-85 microg/kg) whereas three patients (6.7%) needed a third dose of rFVIIa (dose range of 40-60 microg/kg). There was a marked and significant reduction in transfusion requirements for packed red blood cells (P=.0078). Overall transfusion requirements significantly decreased after the infusion of rFVIIa (P=.0323). Nineteen patients (42.2%) died and thrombosis was documented in 3 patients (6.7%).


CONCLUSIONS
Use of rFVIIa should be based on sound clinical evidence to balance the risks, benefits, and cost if used among non-hemophiliacs. Prospective randomized studies are needed to investigate the efficacy and cost-effectiveness of rFVIIa for this indication and to allow a final assessment of the importance of this treatment.
AlGahtani
Farjah H
FH
Division of Hematology, Department of Medicine, King Saud University, Riyadh, Saudi Arabia.
Alshaikh
Mashael
M
AlDiab
AbdulRehman
A
D018806:APACHE; D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D001803:Blood Transfusion; D015942:Factor VIIa / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006470:Hemorrhage / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality; D006489:Hemostatic Techniques; D006801:Humans; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000627:therapeutic use*; D012189:Retrospective Studies; D012307:Risk Factors; D012529:Saudi Arabia; D013223:Statistics as Topic; D014947:Wounds and Injuries / Q000150:complications; D055815:Young Adult
D011994:Recombinant Proteins; D015942:Factor VIIa