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.