title: In Vitro Comparative Assessment of Mechanical Blood Damage Induced by Different Hemodialysis Treatments.
abstract: Gradual deterioration of red blood cells (RBCs) due to mechanical stress (chronic hemolysis) is unavoidable during treatments that involve extracorporeal blood circulation, such as hemodialysis (HD). This effect is generally undetectable and does not generate any acute symptoms, but it leads to an increase in plasma free hemoglobin (fHb). There are no absolute safety levels for fHb increase, indicating the need for an empirical evaluation using comparative testing. The increase in fHb levels was investigated in vitro by applying double-needle double-pump HD (HD-DNDP), a new modality in which arterial and venous pumps both run continuously. fHb was measured during typical and worst-case simulated dialysis treatments (double-needle single-pump HD [HD-DNSP], hemodiafiltration [HDF-DN], single-needle double-pump HD [HD-SNDP], and HD-DNDP) performed in vitro using bovine blood for 4 h. Hemolysis-related indices (fHb%; index of hemolysis, IH; and normalized IH) were calculated and used for comparison. The increase in fHb during either HDF-DN or HD-SNDP with Artis and AK200 dialysis machines was similar, while the fHb at the maximum real blood flow rate (Qbreal ) at the completion of the HD-DNDP treatment on Artis was higher than that for HD-DNSP using a Phoenix dialysis machine (fHb% = 1.24 ± 0.13 and 0.92 ± 0.12 for the Artis machine with HD-DNDP at Qbreal  = 450 mL/min and Phoenix with HD-DNSP at Qbreal  = 500 mL/min, respectively). However, the fHb levels increased linearly, and no steep changes were observed. The increases observed during HD-DNDP were the same order of magnitude as those for widely used bloodlines and treatment modes for delivering dialysis treatments. The observed results matched literature findings, and thus the measured fHb trends are not predicted to have clinical side effects. HD-DNDP treatment with Artis does not merit any additional concern regarding mechanical stress to RBCs compared with that observed for routinely used dialysis treatments, bloodlines and machines. Although the in vitro measurement of the fHb increase in bovine blood does not allow a prediction of the absolute level of blood mechanical damage or the possible effects in humans, such measurements are valuable for assessing hemolytic harm by performing tests comparing the proposed treatment with existing devices.
authors.affiliation: Research & Development, Gambro Dasco SpA, Medolla (MO), Italy.
authors.forename: Ranko
authors.initials: R
authors.lastname: Sakota
authors.affiliation: Research & Development, Gambro Dasco SpA, Medolla (MO), Italy.
authors.forename: Carlo Alberto
authors.initials: CA
authors.lastname: Lodi
authors.affiliation: Research & Development, Gambro Dasco SpA, Medolla (MO), Italy.
authors.forename: Sara Antonia
authors.initials: SA
authors.lastname: Sconziano
authors.affiliation: Medical & Safety Office, Gambro Dialysatoren GmbH, Hechingen, Germany.
authors.forename: Werner
authors.initials: W
authors.lastname: Beck
authors.affiliation: Medical & Safety Office, Gambro, Washington, DC, USA.
authors.forename: Juan P
authors.initials: JP
authors.lastname: Bosch
mesh_terms: D000818:Animals; D015415:Biomarkers / Q000097:blood; D001783:Blood Flow Velocity; D002417:Cattle; D004867:Equipment Design; D004912:Erythrocytes / Q000378:metabolism* / Q000473:pathology; D006454:Hemoglobins / Q000378:metabolism*; D006461:Hemolysis; D016014:Linear Models; D008954:Models, Biological; D012079:Renal Circulation; D006435:Renal Dialysis / Q000009:adverse effects* / Q000295:instrumentation / Q000379:methods; D013314:Stress, Mechanical; D013997:Time Factors; D015854:Up-Regulation
chemical_list: D015415:Biomarkers; D006454:Hemoglobins
keywords: Blood pump; Dialysis machine; Extracorporeal circuit; Hemodialysis; Hemolysis; Hemolysis index; Patient safety; Plasma free hemoglobin