Use of recombinant activated factor VII for intractable bleeding in patients without hemophilia: A developing country tertiary care center's experience.

ABSTRACT

Although the use of recombinant activated factor VII (rFVIIa) to control intractable bleeding in nonhemophiliac patients is expanding, several issues pertinent to its potential thrombotic complications and effect on patient mortality are still of concern. We herein describe our experience at a developing country tertiary care center over a period of 4 years. A total of 49 patients were identified of whom 28.6% belong to the pediatric age group. The most common bleeding settings were intracerebral hemorrhage, abdominal aortic surgery, general surgery, and disseminated intravascular coagulopathy. All patients achieved cessation or significant reduction in bleeding. Only 1 patient had a documented postuse thrombotic complication. Of the whole group, 12 patients (24.4%) eventually died with only 1 death having a possible association to rFVIIa use. There was a statistically significant reduction in the need for blood product transfusion after the use of rFVIIa. The use of rFVIIa was in accordance with the hospital's algorithm (identifying salvageable patients, preconditioning, blood product replacement, and dosing) in 30 (61.2%) patients. We conclude that rFVIIa should continue to be considered in nonhemophiliac patients failing to respond to conventional measures of bleeding control. However, this off-label use should be coupled with strict adherence to the treatment algorithms, which remains essential in developing countries with limited health care resources.