Administration of recombinant factor VIIa decreases blood loss after blunt trauma in noncoagulopathic pigs.

Background: Activated factor VII catalyzes the activation of clotting factors IX and X within the clotting cascade, and has been used clinically to decrease bleeding in patients with hemophilia and other bleeding disorders. Studies suggest the use of recombinant VIIa (rVIIa) may decrease bleeding after injury in the presence of a coagulopathy, but there is conflicting evidence regarding its use in the absence of coagulopathy. This study was performed to determine whether a single dose of rVIIa would reduce blood loss in noncoagulopathic pigs after blunt trauma.

Methods: Anesthetized pigs were subject to multiple blunt injuries consisting of a femur fracture, liver laceration, and soft-tissue crush injury. Fifteen minutes after the trauma, pigs were randomized to receive a single 120 microg/kg dose of rVIIa or placebo. Mean arterial pressure, heart rate, temperature, and hematocrit (Hct) were measured during a 2-hour period of standardized fluid resuscitation. The primary endpoint was blood loss.

Results: The degree of trauma in the two groups was similar. Animals in the treated group had a mean blood loss of 19.6 mL/kg (13.5-25.7) versus 30.0 mL/kg (24.8-35.3) in the control group (p = 0.037).

Conclusions: A single dose of 120 microg/kg of rVIIa can significantly decrease blood loss in traumatized pigs with no preexisting coagulopathy. Further studies are required to determine the lowest effective dose of this medication.