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

• Published in: Current surgery Vol. 63; no. 4; pp. 246 - 251
• Main Authors: McMullin, Neil R., Kauvar, David S., Currier, Heather M., Baskin, Toney W., Pusateri, Anthony E., Holcomb, John B.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-07-2006
• Subjects: Adolescent; Adult; Aged; Blood Coagulation Disorders - drug therapy; Blood Coagulation Disorders - etiology; coagulopathy; Critical Illness - therapy; Factor VII - administration & dosage; Factor VII - therapeutic use; Factor VIIa; hemorrhage; Hemostatics - administration & dosage; Humans; Middle Aged; Postoperative Period; Prothrombin Time; recombinant factor VIIa; Recombinant Proteins - administration & dosage; Recombinant Proteins - therapeutic use; Retrospective Studies; Surgical Procedures, Operative; thromboembolism; trauma; Treatment Outcome; Wounds and Injuries - complications; Wounds and Injuries - physiopathology; trauma; thromboembolism; coagulopathy; recombinant factor VIIa; hemorrhage
• ISSN: 0149-7944; 1879-0321
• DOI: 10.1016/j.cursur.2006.03.007

In bleeding patients who are coagulopathic, the clinical response to administration of recombinant factor VIIa (rFVIIa) relates to the changes in prothrombin time (PT).
Retrospective review of all surgical and trauma patients who were coagulopathic and received factor VIIa at the authors’ institution over the past 27 months.
Academic tertiary referral facility and level I trauma center.
Eighteen patients met inclusion criteria, 10 trauma and 8 surgical. Mean age 50 years (range, 17-84).
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 ± 4 seconds to 12 ± 2 seconds, p < 0.05 (n = 17). International Normalized Ratio (INR) decreased from 1.59 to 0.86, p < 0.05 (n = 17). Fibrinogen before administration was 299.73 (range, 105-564) (n = 15). pH before administration was 7.25 (±0.18) (n = 10). Patient temperature was 98.64 (±2.06). Effect in partial thromboplastin time (PTT) was inconsistent (50 ± 49 seconds to 34 ± 6 seconds, p > 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 significant differences in percentage PT decrease between dose ≥100 mcg/kg vs <100 mcg/kg, surgical vs trauma patients, survivors vs nonsurvivors, and those with pretreatment platelet count ≥100 K vs <100 K.
The administration of rFVIIa caused a decrease in the PT in nearly all patients. There were an insufficient number of patients to support the use of PT as a clinical predictor of response; however, the data are suggestive of such utility. If the PT does not correct, then it is likely that there is a deficiency of other factors of the coagulation cascade.