Clinical and Laboratory Response to Recombinant Factor VIIa in Trauma and Surgical Patients with Acquired Coagulopathy.

摘要

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 + or - 4 seconds to 12 + or - 2 seconds, p less than 0.05 (n = 17). International Normalized Ratio (INR) decreased from 1.59 to 0.86, p less than 0.05 (n = 17). Fibrinogen before administration was 299.73 (range, 105-564) (n = 15). pH before administration was 7.25 ( + or - 0.18) (n = 10). Patient temperature was 98.64 (2.06). Effect in partial thromboplastin time (PTT) was inconsistent (50 + or - 49 seconds to 346 seconds, p greater than 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 sitnfiicant differences in percentage PT decrease between dose greater than or equal to 100 mcg/kg vs less than 100 mcg/kg, surgical vs trauma patients, survivors vs nonsurvivors, and those with pretreatment platelet count greater than or equal to 100 K vs less than 100 K. CONCLUSIONS: The administration of rFVIIa caused a decrease in PT in nearly all patients.