SPTP for UGIB was prepared using previously described methods
11 (link)
. CaCO
3microparticles (3 µm, American Elements, Los Angeles, California, United States) were loaded with human α-thrombin (Haematologic Technologies, Essex Junction, Vermont, United States) and excipients in 6.75-mL cold glycine-buffered solution. The suspension was frozen by liquid nitrogen and lyophilized at –40 ⁰C and < 50 mTorr until dried. The dried CaCO
3/thrombin powder particles were adjusted to diameters < 100 µm and mixed mechanically with a proprietary organic acid ground to the same particle size. SPTP was prepared with thrombin concentrations ranging from 333 NIH units/g to 1000 NIH units/g. A total of 15 g of powder was loaded into the spray device and was available for each bleed. The actual dose of thrombin delivered, and the actual amount of powder used are reported in
Table 1.