A hemolysis study of an intravascular blood cooling system for localized organ tissue cooling

Therapeutic hypothermia can reduce both ischemic and reperfusion injury arising after strokes and heart attacks. New localized organ cooling systems offer a way to reduce tissue damage more effectively with fewer side effects. To assess initial blood safety of our new organ cooling system, the CoolGuide Cooling System (CCS), we investigated safe operating conditions and configurations from a hemolysis perspective. The CCS consists of a peristaltic pump, a custom-built external heat exchanger, a chiller, biocompatible polyvinyl cellulose (PVC) tubing, and a control console. The CCS cools and circulates autologous blood externally and re-delivers cooled blood to the patient through a conventional catheter inserted directly into the organ at risk. Catheter configurations used included: a 7F guide catheter only, a 7F guide with a 0.038" wire inserted through the center and advanced 2 cm distal to the catheter distal tip, a 6F guide catheter only and a 6F guide with a 0.014" guidewire similarly inserted through the center. Using porcine blood, an in vitro test rig was used to measure the degree of hemolysis generation, defined as the percentage change in free hemoglobin, adjusted for total hemoglobin and hematocrit, between exiting and entering blood. The highest degree of hemolysis generation was 0.11±0.04%, based on the average behavior with a 6F catheter and a 0.014" guidewire configuration at a blood flow rate of approximately 130 mL/min. In terms of average percentage free hemoglobin exiting the system, based on total hemoglobin, the highest value measured was 0.17%±0.03%, using this 6F and 0.014" guidewire configuration. This result is significantly below the most stringent European guideline of 0.8% used for blood storage and transfusion. This study provides initial evidence showing hemolysis generation arising from the CoolGuide Cooling System is likely to be clinically insignificant.