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Bofford KD, Riou B, Warren B, et al. J Trauma 2005;59:8-18.

Recombinant Factor VIIa as Adjunctive Therapy for Bleeding Control in Severely Injured Trauma Patients: Two Parallel Randomized, Placebo-Controlled, Double-Blind Clinical Trials. Bofford KD, Riou B, Warren B, et al. J Trauma 2005;59:8-18. Background.

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Bofford KD, Riou B, Warren B, et al. J Trauma 2005;59:8-18.

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  1. Recombinant Factor VIIa as Adjunctive Therapy for Bleeding Control in Severely Injured Trauma Patients: Two Parallel Randomized, Placebo-Controlled, Double-Blind Clinical Trials Bofford KD, Riou B, Warren B, et al. J Trauma 2005;59:8-18.

  2. Background • Coagulopathy is a major contributing factor to bleeding related mortality in trauma. • Coagulopathy in association with metabolic acidosis and hypothermia referred to as the “Lethal Triad”. Boffard KD et al. J Trauma 2005;59:8-18.

  3. Purpose • Evaluate the efficacy and safety of rFVIIa as adjunctive therapy for control of bleeding in patients with severe blunt or penetrating trauma. Boffard KD et al. J Trauma 2005;59:8-18.

  4. Methods Blunt or penetrating trauma, 32 centers Inclusion Severely traumatized 6 units PRBC within 4 hours of admission ≥ 16 to < 65 years Exclusion Cardiac arrest, GSW head, GCS < 8 unless NL CT, BD > 15, pH < 7, 8 or more units PRBC prior to arrival to trauma center, injury ≥12 hours prior to randomization Boffard KD et al. J Trauma 2005;59:8-18.

  5. Methods • Two parallel trials • Blunt trauma and penetrating trauma • Intervention • Randomization to rFVIIa or PL • Dose 200mcg, 100mcg, 100mcg at 0,1,3 hours, respectively, administered after the 8th unit PRBC • Monitoring • Transfusion and infusion requirements 48 h after rFVIIa • Blood samples to evaluate changes in coagulation and blood biochemistry parameters Boffard KD et al. J Trauma 2005;59:8-18.

  6. End Points • Primary end point • RBC units 48 hours after first rFVIIa dose. • Secondary end points • Other transfusion products, mortality, days on ventilator, ICU LOS. • Adverse events, coagulation-related lab variables • Composite of death and critical complications • MOF and ARDS Boffard KD et al. J Trauma 2005;59:8-18.

  7. Results- RBC Transfusions Estimated PL rFVIIa RBC reduction p N Median N Median [90% CI] Blunt (# of Units) (# of Units) (# of Units) Alive 48 h 59 7.5 (0-35) 52 7.0(0-29) 2.6[0.7;4.6] 0.02 All patients 72 7.2 (0-35) 64 7.8(0-48) 2.0[0.0;4.6] 0.07 Penetrating Alive 48 h 52 4.2 (0-41) 57 3.9(0-30) 1.0[0.0;2.6] 0.10 All patients 61 4.8 (0-41) 69 4.0(0-37) 0.2[-0.9;2.4] 0.24 Boffard KD et al. J Trauma 2005;59:8-18.

  8. Results- Need for Massive Transfusion P=0.03 P=0.08 Boffard KD et al. J Trauma 2005;59:8-18.

  9. Results- Mortality Blunt Trauma Penetrating Trauma PL (n=74) rFVIIa (n=69) p PL (n=64) rFVIIa (n=70) p Mortality 48 h M 13(18%) 13(19%) 1.00 10(16%) 12(17%) 1.00 30 d M 22(30%) 17(25%) 0.58 18(28%) 17(24%) 0.69 Boffard KD et al. J Trauma 2005;59:8-18.

  10. Results- Clinical Outcomes Blunt Trauma Penetrating Trauma PL (n=74) rFVIIa (n=69) p PL (n=64) rFVIIa (n=70) p 30 day complication ARDS 12(16%) 3(4%) 0.03 5(8%) 4(6%) 0.74 MOF 9(12%) 5(7%) 0.41 7(11%) 2(3%) 0.09 Mortality, ARDS, or MOF 31(42%) 20(29%) 0.16 22(34%) 20(29%) 0.57 Vent free(d) 13 (0-29) 17(0-29) 0.43 20(0-29) 25(0-29) 0.21 ICU free(d) 8 (0-29) 12(0-29) 0.31 18(0-29) 23(0-29) 0.34 Boffard KD et al. J Trauma 2005;59:8-18.

  11. Results- Adverse Events Blunt Trauma Penetrating Trauma PL (n=74) rFVIIa (n=69) PL (n=64) rFVIIa (n=70) Serious adverse events Patients 49(66%) 44(64%) 36(56%) 36(51%) No. events 109 91 76 57 Thrombotic adverse events Patients 3(4%) 2(3%) 3(5%) 4(6%) No. events 3 2 3 4 Boffard KD et al. J Trauma 2005;59:8-18.

  12. Conclusions • rFVIIa significantly improved bleeding control in blunt trauma • Decrease RBC transfusions • Decrease in number of patients requiring massive transfusion • Similar trend in patients with penetrating trauma • Adverse events were not increased with rFVIIa Boffard KD et al. J Trauma 2005;59:8-18.

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