Blood Volume Replacement Technology

As a consequence of the successful applications of AQIX® RS-I solution in maintaining the functional viability of human cadaver tissues and organs following hypothermic storage and normothermic perfusion, trials were conducted using a preclinical model for hemorrhagic shock to assess the suitability of this solution as a blood volume replacement therapy in clinical situations.

Essentially, the results of the preclinical Phase I ‘safety’ and Phase II ‘hemorrhagic trauma’ trials were positive when compared to volume replacement using autologous blood [AB] and significantly better in comparison to the current standard solution, Lactated Ringers [LR].

Of particular note, was the significantly rapid restoration of all hemodynamic parameters (see, Table 2) and, more importantly, the minimal reperfusion injury damage caused by AQIX® RS-I (in comparison to LR saline) to essential organs such as the kidney, liver, lung and the center of homeostatic control mechanisms, the hippocampus (see, Table 3a,b).

Table 2 Rate of Restoration of Hemodynamic Values during first 30 minutes of fluid replacement

Table 3a Organ Reperfusion Injury (RI) - Morphometric Graded Assessment of Kidney

Table 3b Organ Reperfusion Injury (RI) - Morphometric Graded Assessment of Liver, Lung and Brain

Concluding Remarks

The preclinical investigation involving a preclinical hemorrhagic model were based on the critique that following near fatal blood loss in patients, the accompanying changes in hemodynamics and blood chemistry should be restored to normality within the critical 30-60 minutes following hemorrhagic trauma in order to minimize the reported incidence of reperfusion injury that develops over the next 48-72 hours in essential organ systems.

To achieve this outcome, the preclinical study was particularly focused on monitoring specific hemodynamic and blood chemistry parameters, namely, how quickly and maintained effectively during the resuscitation period could these parameters be restored to baseline values as stated below;

1. the mean arterial pressure (MAP) to within 65% of baseline
2. the cardiac output (CO) and stroke volume (SV)
3. the central venous (CVP) and pulmonary arterial occlusion (PAOP) pressures
4. the ratio of central to pulmonary pressures (CVP:PAOP)
5. the capillary hydrostatic pressure (pCAP)
6. the systemic (SVR) and pulmonary (PVR) vascular resistances

Overall, from the data presented in this study, all of the above parameters recovered quicker and were better maintained in the AQ-group over the experimental time periods than that observed in either the AB or LR-groups.

Of importance in this study was to evaluate the chemical aspects of administering AQIX® RS-I solution intravenously in that there be no incidence of hyperchloremic (metabolic) acidosis, a common finding in clinical practice with volume replacement fluids. The fact that no disturbance in acid-base balance, anion gap (GAP) or Strong Ion Difference (SID) was observed in the AQ-group examined over a period of seven days, as evidenced by sustained bicarbonate and chloride ion levels, probably relates to the fact that the calculated anion gap [3-8.5 mmole/L] for AQIX® RS-I resides within the preferred, normal range of 3 – 11 mmole/L. The beneficial effects of utilizing physiologically, balanced solutions have been reported previously, whereby, the use of ‘balanced’ crystalloid and colloid solutions in elderly surgical patients prevented the development of hyperchloremic metabolic acidosis and resulted in improved gastric mucosal perfusion when compared with saline-based solutions.

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