Single-donor spray-dried plasma.

BACKGROUND: Dried plasma is logistically superior for hemostasis management because it can be transported and stored under nonfrozen conditions and quickly reconstituted at the point of care, enabling prehospital administration. Velico Medical has developed a spray-drying system to be integrated into routine blood center work streams for spray drying single donor plasma units. This study compared the quality of the spray-dried plasma (on-demand plasma [ODP]) with fresh frozen plasma (FFP). STUDY DESIGN AND METHODS: ODP units (n = 60) were manufactured from never frozen fresh plasma, which was pretreated with glycine-hydrochloric acid and stored at 1to 6°C. Paired aliquots were frozen and stored at -18°C or less. After 31 to 33 days, ODP samples were reconstituted with water for injection and comprehensively characterized in parallel with paired FFP. The quantities of plasma dried and rehydration fluid were predetermined, ensuring comparable total protein concentration in ODP and paired FFP. RESULTS: ODP is comparable to FFP in global coagulation function as assessed by activated partial thromboplastin time and prothrombin time and in clot formation evaluated by thrombelastography. Compared to FFP, ODP had greater than 80% levels of functional coagulation factors and related proteins and chemistry analytes except for Factor XIII (74%). Pretreatment mitigated cleavage of high-molecular-weight von Willebrand factor multimers by spray drying and resulted in 60% vWF:ristocetin cofactor activity in ODP compared to FFP. CONCLUSIONS: ODP demonstrates coagulation function comparable to that of FFP. The spray drying system can be implemented in blood centers and is capable of producing units of ODP.

In-vitro thrombogenicity assessment of polymer filament modified and native platinum embolic coils.

BACKGROUND: Embolic coils have been used to treat intracranial aneurysms using an endovascular approach for more than two decades. However, significant aneurysm recanalization rates have been reported specifically in large and giant aneurysms. Adding filaments to bare Platinum coils is considered a modification and has been proposed to achieve higher aneurysm occlusion rates as compared to bare Platinum coils. Quantitative information - in terms of thrombin generation potential of these modifications - is however lacking. OBJECTIVE: We report here in vitro thrombogenicity of Platinum coils containing Nylon (Axium™ MicroFx™ Nylon coil) and PGLA (Axium™ MicroFx™ PGLA coil) filaments and compare them with equivalent bare Platinum Axium™ coils. METHOD: We utilize a quantitative method that tracks the formation of thrombin upon exposure of the test samples to human platelet rich plasma using a slow binding fluorogenic substrate. RESULTS: We report a significant increase in the total thrombin turnover, the peak thrombin amount and the rate of thrombin generation for the Axium™ MicroFx™ coils and filaments compared to the Axium™ coils and Platinum wire. CONCLUSION: Nylon and PGLA filaments added to bare Platinum coils increase thrombogenicity of coils. This study offers a robust quantitative method to compare thrombus formation efficacy of embolic coils under static conditions.