OBJECTIVE: To review the evidence supporting the use of prothrombin complex concentrate (PCC) as a hemostatic agent in individuals without hemophilia. DATA SOURCES: Articles were identified through a search of Ovid/MEDLINE (up to April 2011) and Cochrane Central Register of Controlled Trials (up to April 2011). The search terms used were prothrombin complex concentrate, hemorrhage, and bleeding. STUDY SELECTION AND DATA EXTRACTION: The search was limited to comparative studies. Bibliographies of retrieved articles were reviewed to obtain additional articles. The intent of the search was to identify original research comparing PCC to fresh frozen plasma (FFP) or recombinant factor VIIa for the management of bleeding in patients without hemophilia. DATA SYNTHESIS: PCCs are recommended as an alternative to FFP and recombinant factor VIIa for the treatment of serious or life-threatening bleeding related to vitamin K antagonist therapy. Studies in this setting have shown that PCCs are safe and effective and provide prompt reduction of international normalized ratio (INR) compared to FFP. However, most trials are uncontrolled, and the primary outcomes in these studies have been INR reduction rather than hemostatic effect. Other common off-label uses include coagulopathy due to hepatic failure and traumatic hemorrhage; however, there is insufficient evidence to support use of PCC in these settings. Advantages of PCC include the low drug volume required compared to FFP. The use of PCC may be associated with thrombo-embolic complications. CONCLUSIONS: PCC is a safe and effective alternative to FFP and provides rapid reversal of INR in patients on vitamin K antagonist therapy. These agents may be advantageous compared to FFP in patients with volume restrictions. Comparative trials are needed to compare the various PCC products, FPP, and recombinant factor VIIa with regard to clinically significant outcomes such as hemostatic effect.
OBJECTIVE: To determine the effects of ethanol (EtOH) ingestion by trauma patients on the hematologic system as evidenced by coagulation abnormalities and transfusion requirements. DESIGN: Retrospective chart review. The injury severity score (ISS) was determined for each patient. Patients were grouped according to presence of EtOH (+EtOH) and absence of EtOH (-EtOH) with further subdivision based on an ISS ≤8 or ≥9. SETTING: University medical center. PATIENTS: All adult trauma patients admitted during a one-month period. MAIN OUTCOME MEASURES: The volume of resuscitation fluids (including blood products) administered, laboratory parameters indicative of bleeding, and length of stay. RESULTS: Of 104 evaluable patients, 38 had measurable EtOH concentrations, 46 had undetectable EtOH concentrations, and the remaining 20 patients had not been tested. Although isolated, statistically significant differences were found among groups for some of the outcome measures, there were no clinically important differences. CONCLUSIONS: EtOH ingestion prior to injury did not appear to cause significant alterations in the hematologic system of trauma patients, but a larger study is needed to confirm these findings.
Unfortunately, research related to drug dosing in overweight and obese patients has not kept pace with studies concerning the epidemiology and complications of obesity. The pivotal trials leading to drug approval typically include relatively few patients with extremes of weight relative to height. They usually focus on patients in non-ICU settings, and in some cases specifically exclude patients beyond a predefined weight. Furthermore, when the results of clinical trials are reported, patient weights are usually expressed in terms of summary statistics. Although patient weight is often the focus of discussions of drugs administered using weight-based dosing regimens, other factors such as height and body composition must be taken into account. As much as possible and practical, the way in which weight is estimated, measured, recorded, and utilized for drug dosing should be standardized to reduce variability that might lead to dosing errors. © 2012 John Wiley & Sons, Ltd.