Effectiveness of Erythrocyte Morphology Observation as an Indicator for the Selection and Qualification of Blood in a Mechanically Induced Hemolysis Test
Source abstract
Abstract
Background: This study was conducted to confirm the reliability of an in vitro mechanically induced hemolysis test (ISO 10993-4:2017), which is essential for ensuring the safety of blood pumps. Methods: For appropriate anticoagulant selection, porcine blood was prepared in anticoagulant citrate dextrose solution A (ACD-A), heparin, and citrate phosphate dextrose adenine (CPDA-1), respectively, according to the ASTM F1830 standard. Anticoagulant-treated porcine and bovine blood were circulated in a mock circulatory loop (MCL) for 6 h to observe the rate of plasma-free hemoglobin (pfHb) and RBCs with morphological integrity. Results: A morphological loss of red blood cells (RBCs) was observed over time. While there were differences in morphological loss depending on the anticoagulant, no consistent trend could be identified. The pfHb concentration was significantly higher in bovine than in porcine blood. Conversely, the number of RBCs with morphological integrity decreased over time in both, but the ratio of RBCs with morphological integrity was similar across all timepoints. Conclusions: The percentage of RBCs with morphological integrity can be used as a reliable indicator for the interpretation of mechanically induced hemolysis results in different blood types. Furthermore, the reliability of the in vitro mechanically induced hemolysis test (ISO 10993-4:2017) was assessed.
Source: crossref · Quality: baseline
Research context
OpenAlex topics: Mechanical Circulatory Support Devices · Cardiac Arrest and Resuscitation · Intravenous Infusion Technology and Safety
SciVX discovery tags are terminology-based. OpenAlex topics are source-provided classifications.
Affiliations
Bio-Health Center (GLP), Korea Testing Certification Institute, Cheongju 28115, Republic of Korea
Department of Medical Device Research Division, National Institute of Food and Drug Safety Evaluation, Cheongju 28159, Republic of Korea
Funding
Ministry of Food and Drug Safety
References (31)
Show source-provided references
1. (2017). Biological Evaluation of Medical Devices—Part 4: Selection of Tests for Interactions with Blood (Standard No. ISO 10993-4).
2. Baskurt, O.K., Hardeman, M.R., Rampling, M.W., and Meiselmen, H.J. (2007). Handbook of Hemorheology and Hemodynamics, IOS Press.
3. Bleeding and thrombosis in patients with continuous-flow ventricular assist devices10.1161/CIRCULATIONAHA.111.040246 ↗
4. Haemolysis induced by mechanical circulatory support devices: Unsolved problems10.1177/0267659120931307 ↗
5. Mechanical stress-induced hemolysis of bovine blood is donor-dependent10.1111/aor.14412 ↗
6. (2019). Standard Practice for Collection and Preparation of Blood for Dynamic In Vitro Evaluation of Hemolysis in Blood Pumps (Standard No. ASTM F1830-19).
7. (2019). Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps (Standard No. ASTM F1841-19).
8. In vitro hematological testing of rotary blood pumps: Remarks on standardization and data interpretation10.1111/j.1525-1594.1993.tb00419.x ↗
9. Does hematocrit affect in vitro hemolysis test results? Preliminary study with Baylor/NASA prototype axial flow pump10.1111/j.1525-1594.1994.tb03394.x ↗
10. Biomaterial testing for covered stent membranes: Evaluating thrombosis and restenosis potential10.1002/jbm.b.31927 ↗
11. The CentriMag centrifugal blood pump as a benchmark for in vitro testing of hemocompatibility in implantable ventricular assist devices10.1111/aor.12351 ↗
12. In vitro thrombogenicity testing of pulsatile mechanical circulatory support systems: Design and proof-of-concept10.1111/aor.14046 ↗
13. Evaluation of in vitro hemolysis and platelet activation of a newly developed maglev LVAD and two clinically used LVADs with human blood10.1111/aor.13471 ↗
14. Validation of a Miniaturized Test Loop for the Assessment of Human Blood Damage by Continuous-Flow Left-Ventricular Assist Devices10.1007/s10439-021-02849-1 ↗
15. Miniaturized Test Loop for the Assessment of Blood Damage by Continuous-Flow Left-Ventricular Assist Devices10.1007/s10439-019-02404-z ↗
16. Potential Factors for Poor Reproducibility of In Vitro Hemolysis Testing10.1097/MAT.0000000000001577 ↗
17. Superiority of centrifugal pump over roller pump in paediatric cardiac surgery: Prospective randomised trial10.1016/S1010-7940(98)00067-0 ↗
18. Centrifugal pump and heparin coating improves cardiopulmonary bypass biocompatibility10.1016/0003-4975(96)00492-4 ↗
19. Hemolysis during cardiac extracorporeal membrane oxygenation: A case-control comparison of roller pumps and centrifugal pumps in a pediatric population10.1097/MAT.0b013e31822e2475 ↗
20. Haemolysis during cardiopulmonary bypass: An in vivo comparison of standard roller pumps, nonocclusive roller pumps and centrifugal pumps10.1177/026765919901400102 ↗
21. Comparison of the centrifugal and roller pump in elective coronary artery bypass surgery—A prospective, randomized study with special emphasis upon platelet activation10.1080/14017430310015523 ↗
22. Effects of centrifugal and roller pumps on survival of autologous red cells in cardiopulmonary bypass surgery10.1177/0267659106073976 ↗
23. Hemolysis and Inflammatory Response to Extracorporeal Circulation during On-Pump CABG: Comparison between Roller and Centrifugal Pump Systems
24. Mechanical properties of the red cell membrane in relation to molecular structure and genetic defects10.1146/annurev.bb.23.060194.004035 ↗
25. Red cell membrane disorders10.1111/ijlh.12657 ↗
26. Neue methode der quantitativen mikroskopischen Analyse des Blutes
27. Zählungen der Blutkörperchen des Menschen
28. A Reusable, Compliant, Small Volume Blood Reservoir for In Vitro Hemolysis Testing10.1111/aor.12724 ↗
29. Speed Modulation of the HeartWare HVAD to Assess In Vitro Hemocompatibility of Pulsatile and Continuous Flow Regimes in a Rotary Blood Pump10.1111/aor.13142 ↗
30. Mock circulation loop to investigate hemolysis in a pulsatile total artificial heart10.1111/aor.12399 ↗
31. Relationship of hyperthermia-induced hemolysis of human erythrocytes to the thermal denaturation of membrane proteins10.1016/0005-2736(89)90399-4 ↗