Methods
In each experiment, duplicate glass volumetric flasks containing 200mL of either 0.9%w/v saline solution or Ringer’s Lactate were accurately prepared. A 200mL volume was selected as this was reported to be the smallest volume of IV fluids used at the E-MOTIVE implementation sites. Therefore, this volume likely represents the greatest risk if compatibility issues exist, as it will lead to the highest concentration of active compounds once added to the IV solution.
Into each flask, one 1mL ampoule of OXY (10IU, ~17ug) and two 5mL ampoules of TXA injection (1000mg) were added and the bulk solution mixed vigorously. On completion of mixing, 1 mL of solution was immediately removed for analysis from the duplicate solutions and the remaining bulk solutions were transferred to an empty IV infusion bag. The bag was stored under ambient conditions and further duplicate samples taken over a period of 6 hours.
The following two combinations of products were evaluated in these experiments, OXY A with TXA A and OXY B with TXA B.
Based on the results of these experiments, the compatibility of the reverse combinations of products was then evaluated, specifically OXY A with TXA B and OXY B with TXA A. However, in these experiments, the bulk solutions, once mixed, were not transferred into IV infusion bags, but stored under ambient conditions in the glass volumetric flasks in which they were prepared. This change was made to eliminate the possibility of surface effects (e.g. adhesion, adsorption etc.) within the bags. In addition, the stability of the solutions in terms of the OXY concentration only was evaluated for a reduced period of approximately 30 minutes, reflecting the results observed in the first experimental series.