A multicenter assessment of recombinant factor VIIa off-label usage: clinical experiences and associated outcomes.

BACKGROUND: Off-label use of recombinant factor VIIa (rFVIIa) occurs despite minimal data. The purpose of this study was to describe prescribing practices and clinical outcomes for off-label rFVIIa use. STUDY DESIGN AND METHODS: A retrospective, multicenter chart audit of 315 nonhemophiliac patients was performed. RESULTS: Off-label indications included prevention of bleeding primarily related to procedural manipulation in 37.8 percent of patients and treatment of bleeding in 62.2 percent of patients. Baseline coagulopathy was present in 79.7 percent of patients. Prescriber specialty varied. The median doses for prevention and treatment were 75.6 and 89.4 microg per kg, respectively (p = 0.0006). The international normalized ratio (INR) decreased (p < 0.0001) from baseline in both groups. Transfusions of blood products were provided to 85.1 percent of patients before rFVIIa administration with considerable practice variation. Few patients received other procoagulant agents. In the prevention group, 14.3 percent of patients bled within 6 hours of their procedure. No variable was independently associated with bleeding prevention. In the treatment group, 52.6 percent of patients stopped bleeding within 6 hours of rFVIIa administration. The only independent variable associated with bleeding cessation was an arterial pH value of less than 7.20, which was a negative predictor (odds ratio, 0.207; 95% confidence interval, 0.084-0.507). Possible rFVIIa-associated adverse events occurred in 9.8 percent of patients and primarily involved undesirable clotting. No variable was independently associated with adverse events. CONCLUSIONS: Off-label use of rFVIIa includes prevention and treatment of bleeding. rFVIIa is associated with INR reduction. Bleeding is rare with prophylactic rFVIIa but the cessation of bleeding is less than reported in the literature and may be related to pH. Possible adverse events are related to undesirable clotting.

Evaluation of the appropriate use of albumin in adult and pediatric patients.

The appropriateness of albumin use and baseline albumin usage patterns were studied. Institutional practice patterns regarding the use of albumin were compared to criteria established by an independent expert panel. Fifty-three institutions, all of which were members of VHA or the University Health-System Consortium, participated in the evaluation. Investigators collected data over an eight-week period from the medical records, pharmacy records, and hospital billing data of adult (18 years of age or older) and pediatric (age 1-17 years) patients for whom albumin was prescribed. Data collected included patient-specific information, the prescribing physician's specialty area, patient location (level of care) when albumin was prescribed, primary reasons for prescribing albumin, and details of albumin use. Data were collected for 1649 adult and 23 pediatric patients. Albumin was prescribed inappropriately in 57.8% and appropriately in 28.2% of adults; appropriateness of use was unknown in 14% of the patients reviewed. The most common indication for albumin use was hypotension/hypovolemia (23.9%), followed by bypass-pump priming (16.3%), intradialytic blood pressure support (9.6%), and serum albumin values less than 2 g/dL (8.6%). Albumin was prescribed inappropriately 100% of the time when used for intradialytic blood pressure support, low serum albumin values, and acute respiratory distress syndrome. The most appropriate use of albumin occurred in patients with postsurgical hypotension and hypovolemia (67.8%), nephrotic syndrome (79.3%), non-hemorrhagic shock (44.3%), hemorrhagic shock (51.9%), and cirrhosis and paracentesis (31.3%). Albumin was inappropriately prescribed for 57.8% of adult patients and 52.2% of pediatric patients. The mean number of total grams used by patients receiving albumin appropriately was similar to those patients inappropriately receiving albumin.