Improved plasma removal efficiency for therapeutic plasma exchange using a new apheresis platform.

BACKGROUND: The Spectra Optia (SPO; CaridianBCT) is a new apheresis device based on the COBE Spectra (CSP; CaridianBCT) platform. This study was designed to evaluate the safety and efficiency of the SPO in comparison to the predicate CSP device. STUDY DESIGN AND METHODS: Twenty patients were recruited for a randomized, nonblinded, paired (crossover) clinical trial comparing the SPO to the CSP (pivotal trial). The primary outcome measure was plasma removal efficiency (PRE); secondary outcomes included platelet (PLT) content and hemolysis in the waste plasma, changes in patient cellular counts, patient coagulation and complement cascade activation, accuracy of machine fluid balance measurement, and review of significant adverse events (SAEs). RESULTS: Overall SPO demonstrated 87% PRE with 1.0% PLT loss; these variables were statistically different from CSP (79 and 3.0%, respectively). The accuracy of anticoagulant usage, plasma removal, and fluid replacement as measured by the SPO fluid pumps was 97% or more; fluid balance was within 2% of the measured value. After apheresis there were no statistical changes in patient cellular counts with respect to the initial values. Patient d-dimer and prothrombin fragment 1.2 assays showed no activation of the coagulation system with either device. Measurement of patient C3a, C5a, and plasma free hemoglobin showed no significant differences between the SPO and the CSP. No SAEs were reported. CONCLUSION: The SPO has improved performance characteristics over the CSP. Based on our results, the SPO is acceptable for use in therapeutic plasma exchange programs.

Platelet-related bleeding: an update on diagnostic modalities and therapeutic options.

Platelet-related bleeding is a pervasive and potentially life-threatening problem that can arise in both acute and chronic clinical settings. A growing number of laboratory assays have been developed to rapidly assess underlying platelet dysfunction in the bleeding patient. This article: (1) provides an overview of the current methods of platelet function testing, with a particular emphasis on recently developed "point-of-care" tests, (2) reviews evidencebased transfusion "triggers" and provides an update on new developments in platelet component therapy, and (3) outlines those initial studies that have demonstrated how point-of-care platelet function testing has helped lead to the development of targeted transfusion strategies for the acutely bleeding patient.

Terminal ileal atresia, total colonic aganglionosis, and thrombophilia.

Inherited thrombophilia, a predisposition for a hypercoagulable state, has been associated with cases of intestinal atresia. In this communication, we report a case of terminal ileal atresia and total colonic aganglionosis (Hirschsprung's disease), a rarely documented association, in a neonate who seemed to have a hypercoagulable state. The case stresses the need for recognition of this sequence of events in order to achieve optimal management.