PURPOSE: Recombinant activated factor VII (rFVIIa) was introduced as a prohemostatic agent, but it has also been approved for spontaneous bleeding, surgical or invasive procedures in congenital or acquired hemophilia. However, out of label uses have increasingly been indicated, particularly in patients with acquired coagulation disorders and severe bleeding without response to therapy. Aim: To acknowledge the usefulness of rFVIIa, in patients with acute uncontrolled severe bleeding (AUSB) without response to conventional therapy in a critical care units.
METHODS: From March 2006 to February 2007 we studied a series of consecutive patients with AUSB and different underlying pathologies. All of them received a single dose of 80 μg/kg IV of rFVIIa. We obtained clinical, demographics and morbidity data. Statistical Analysis: Variables are expressed as mean±standard deviation (M±SD). Paired-t test were done for differences between pre-post rFVIIa administration. A p-value <0.05 was considered significant.
RESULTS: We studied 35 patients of 48.89±18.63 yo. The etiologies were post-surgery bleeding 12(34.3%), thoraco-abdominal trauma 12(34.3%), Upper and lower gastrointestinal bleeding 7(20%) and intracranial bleeding 4(11.4%). Acute bleeding stopped after 8.11±4.94 min of study-drug administration. The behavior of the variables pre-post rFVIIa were: Heart rate, beats/min (133.74±16.38 vs. 82.88±15.68, p<0.0001, Mean systemic arterial pressure, mmHg (52.14±13.73 vs. 75.02±11.08 p<0.0001), Oxygen arterial saturation, % (88.57±3.78 vs. 97.08±1.5, p<0.0001), Lactic acid (6.13±2.29 vs. 2.37±2.44, p<0.001), Blood units,u(7.55±4.63 vs. 4.63±0.89), Prothrombine time, sec. (21.88±4.18 vs. 12.54±3.42, p<0001), Partial tromboplastine time, sec. (43.31±4.37 vs. 28.42±6.07, p<0.0001). Before rFVIIa, platelet counts in all of them were >125000 μL. We had 2 events of pulmonary thromboembolism after rFVIIa administration and no deaths related to study-drug in our series.
CONCLUSION: Recombinant activated factor VII stopped bleeding and significantly improve the clinical settings in all patients of this series.
CLINICAL IMPLICATIONS: Although controlled studies are necessary to support this findings,rFVIIa could be a good options in this setting.
DISCLOSURE: Hector Peña-Carrillo, No Financial Disclosure Information; No Product/Research Disclosure Information