Cardiopulmonary Bypass System Research Articles

A modified low-priming cardiopulmonary bypass system in patients undergoing cardiac surgery with medium risk of transfusion: A randomized controlled trial

A modified low-priming cardiopulmonary bypass system in patients undergoing cardiac surgery with medium risk of transfusion: A randomized controlled trial

Outcomes of extracorporeal membrane oxygenation treatment post open congenital heart surgery

Objective: ECMO (Extra-Corporeal Membrane Oxygenation) is a technique that temporarily supports heart and lung function by a cardiopulmonary bypass system to treat patients who have failed to respond to the conventional treatments for cardiac or respiratory after congenital heart surgery. The objective of this study is to evaluate the outcomes of ECMO treatment post congenital heart surgery at the National Children's Hospital. Subjects and methods: Descriptive, cross-sectional research method on 64 ECMO patients post open heart surgery from January 1, 2017 until August 30, 2023 at the Department of Surgical Cardiovascular Intensive Care, Cardiovascular Center, National Children's Hospital. Results: Of 64 patients analyzed, the median age of the study group was 1.6 months, 89.1% of patients were children younger than 12 months old; median weight is 3.6 kg. The success rate of ECMO weaning was 56.3%. Overall survival of the cohort was 43.8%. The mean ECMO duration was 5,7 (IQR, 3,7-10,6) days, the mean hospital stay was 32 (IQR, 21,5-50) days, the mean ICU stay was 19,5 (IQR, 13,3-29) days. Mechanical complications during ECMO support include cannula bleeding and circuit thrombus. Acute kidney injury, hypertransaminase, and DIC (disseminated intravascular coagulation) are the most common patient-related complications during ECMO. Conclusion: ECMO is a viable rescue strategy for cardiac surgery patients with ECMO weaning rate and survival rate were 56.3% and 43.8%, respectively, nearly equivalent to other heart centers.

Comparison of minimal invasive extracorporeal circulation versus standard cardiopulmonary bypass systems on coronary artery bypass surgery

Comparison of minimal invasive extracorporeal circulation versus standard cardiopulmonary bypass systems on coronary artery bypass surgery

Optimization of cardiopulmonary bypass prime fluid to preserve microcirculatory perfusion during on-pump coronary artery bypass graft surgery: PRIME study protocol for a double-blind randomized trial

BackgroundAcute microcirculatory perfusion disturbances and organ edema are important factors leading to organ dysfunction during cardiac surgery with cardiopulmonary bypass (CPB). Priming of the CPB system with crystalloid or colloid fluids, which inevitably leads to hemodilution, could contribute to this effect. However, there is yet no optimal evidence-based strategy for this type of priming. Hence, we will investigate different priming strategies to reduce hemodilution and preserve microcirculatory perfusion.MethodsThe PRIME study is a single-center double-blind randomized trial. Patients undergoing elective coronary artery bypass graft surgery with CPB will be randomized into three groups of prime fluid strategy: (1) gelofusine with crystalloid, (2) albumin with crystalloid, or (3) crystalloid and retrograde autologous priming. We aim to include 30 patients, 10 patients in each arm. The primary outcome is the change in microcirculatory perfusion. Secondary outcomes include colloid oncotic pressure; albumin; hematocrit; electrolytes; fluid balance and requirements; transfusion rates; and endothelial-, glycocalyx-, inflammatory- and renal injury markers. Sublingual microcirculatory perfusion will be measured using non-invasive sidestream dark field video microscopy. Microcirculatory and blood measurements will be performed at five consecutive time points during surgery up to 24 h after admission to the intensive care unit.DiscussionPRIME is the first study to assess the effect of different prime fluid strategies on microcirculatory perfusion in cardiac surgery with CPB. If the results suggest that a specific crystalloid or colloid prime fluid strategy better preserves microcirculatory perfusion during on-pump cardiac surgery, the current study may help to find the optimal pump priming in cardiac surgery.Trial registrationClinicalTrials.gov NCT05647057. Registered on 04/25/2023. ClinicalTrials.gov PRS: Record Summary NCT05647057, all items can be found in the protocol.

The outcomes of a standardized protocol for extracorporeal mechanical circulatory support selection-left ventricular challenge protocol.

There are no criteria for surgical mechanical circulatory system (MCS) selection for acute heart failure. Since 2021, we have utilized cardiopulmonary bypass system to assess patients' heart and lung condition to inform surgical MCS selection. we aimed to retrospectively analyze the outcomes of treatments administered using our protocol. We analyzed the data of 19 patients who underwent surgical MCS implantation. We compared patients' characteristics across the biventricular-assist device (BiVAD), central Y-Y extracorporeal membrane oxygenation (ECMO), central ECMO, and left VAD (LVAD) systems. Patients' diagnoses included fulminant myocarditis (47.4%), dilated cardiomyopathy (21.1%), acute myocardial infarction (15.8%), infarction from aortic dissection (5.3%), doxorubicin-related cardiomyopathy (5.3%), and tachycardia-induced myocarditis (5.3%). Eight patients (42.1%) underwent LVAD implantation, 1 (5.2%) underwent central ECMO, 4 (21.1%) underwent BiVAD implantation, and 6 (31.6%) underwent central Y-Y ECMO. 48h after surgery, both the pulmonary arterial and right atrial pressures were effectively controlled, with median values being 19.0mmHg and 9.0mmHg, respectively. No patients transitioned from LVAD to BiVAD in the delayed period. Cerebrovascular events occurred in 21.1%. Successful weaning was achieved in 11 patients (57.9%), and 5 patients (26.3%) were converted to durable LVAD. Two-year cumulative survival was 84.2%. Our protocol showed good results for device selection in patients with heart failure, and device selection according to this protocol enabled good control of the pulmonary and systemic circulations.

The Number of Microbubbles Generated During Cardiopulmonary Bypass Can Be Estimated Using Machine Learning From Suction Flow Rate, Venous Reservoir Level, Perfusion Flow Rate, Hematocrit Level, and Blood Temperature.

Microbubbles (MBs) are known to occur within the circuits of cardiopulmonary bypass (CPB) systems, and higher-order dysfunction after cardiac surgery may be caused by MBs as well as atheroma dispersal associated with cannula insertion. As complete MB elimination is not possible, monitoring MB count rates is critical. We propose an online detection system with a neural network-based model to estimate MB count rate using five parameters: suction flow rate, venous reservoir level, perfusion flow rate, hematocrit level, and blood temperature. Perfusion experiments were performed using an actual CPB circuit, and MB count rates were measured using the five varying parameters. Bland-Altman analysis indicated a high estimation accuracy (R2 > 0.95, p < 0.001) with no significant systematic error. In clinical practice, although the inclusion of clinical procedures slightly decreased the estimation accuracy, a high coefficient of determination for 30 clinical cases (R2 = 0.8576) was achieved between measured and estimated MB count rates. Our results highlight the potential of this system to improve patient outcomes and reduce MB-associated complication risk.

Modified cardiopulmonary bypass with low priming volume for blood conservation in cardiac valve replacement surgery

BackgroundThe adverse effects of cardiopulmonary bypass during open cardiac surgery, including hemodilution, seem to be inevitable, especially for patients who generally have a relatively lower BMI with relatively small blood volumes. This study reports the modification and use of a cardiopulmonary bypass (CPB) system to reduce priming volume and hemodilution.MethodsThis is a retrospective study of 462 adult patients who underwent cardiac valve replacement surgery from January 2019 to September 2021 at the General Hospital of Western Theater Command. The modified group consisted of 212 patients undergoing modified CPB. The control group included 250 patients receiving conventional CPB. Evaluated indices included fluid intake and output volumes during CPB, intraoperative indices related to CPB operation, usage of blood products during the peri-CPB period, and postoperative outcomes.ResultsThe modified group displayed a significant reduction in the crystalloid (200 mL vs. 600 mL, P < 0.05) and colloid priming volumes (450 mL vs. 1100 mL, P < 0.05), and ultrafiltration solution volume (750 mL vs. 1200 mL, P < 0.05). Furthermore, the modified group had a significantly lower rate of defibrillation (30.2% vs. 41.2%, P < 0.05). The intraoperative urine volume (650 mL vs. 500 mL, P < 0.05) and intraoperative hematocrit (Hct) (26% vs. 24%, P < 0.05) of the modified CPB group were also higher than in the control group. The modified group required a lower infusion volume of packed red blood cells (250 mL vs. 400 mL, P < 0.05) and lower infusion rates of packed red blood cells (17.9% vs. 25.2%, P < 0.05) and fresh frozen plasma (1.41% vs. 5.2%, P < 0.05). In addition, the modified group showed significantly improved indices related to postoperative recovery.ConclusionsThe modified CPB system effectively conserves blood and shows noteworthy potential for application in cardiac valve replacement surgery.

Simultaneous Control of Venous Reservoir Level and Arterial Flow Rate in Cardiopulmonary Bypass With a Centrifugal Pump.

Cardiopulmonary bypass (CPB) is an indispensable technique in cardiac surgery, providing the ability to temporarily replace cardiopulmonary function and create a bloodless surgical field. Traditionally, the operation of CPB systems has depended on the expertise and experience of skilled perfusionists. In particular, simultaneously controlling the arterial and venous occluders is difficult because the blood flow rate and reservoir level both change, and failure may put the patient's life at risk. This study proposes an automatic control system with a two-degree-of-freedom model matching controller nested in an I-PD feedback controller to simultaneously regulate the blood flow rate and reservoir level. CPB operations were performed using glycerin and bovine blood as perfusate to simulate flow-up and flow-down phases. The results confirmed that the arterial blood flow rate followed the manually adjusted target venous blood flow rate, with an error of less than 5.32%, and the reservoir level was maintained, with an error of less than 3.44% from the target reservoir level. Then, we assessed the robustness of the control system against disturbances caused by venting/suction of blood. The resulting flow rate error was 5.95%, and the reservoir level error 2.02%. The accuracy of the proposed system is clinically satisfactory and within the allowable error range of 10% or less, meeting the standards set for perfusionists. Moreover, because of the system's simple configuration, consisting of a camera and notebook PC, the system can easily be integrated with general CPB equipment. This practical design enables seamless adoption in clinical settings. With these advancements, the proposed system represents a significant step towards the automation of CPB.

Neural Network-based Estimation of Microbubbles Generated in Cardiopulmonary Bypass Circuit: A Clinical Application Study.

The cardiopulmonary bypass system used in cardiac surgery can generate microbubbles (MBs) that may cause complications, such as neurocognitive dysfunction, when delivered into the blood vessel. Estimating the number of MBs generated, thus, is necessary to enable the surgeons to deal with it. To this end, we previously proposed a neural network-based model for estimating the number of MBs from four factors measurable from the cardiopulmonary bypass system: suction flow rate, venous reservoir level, blood viscosity, and perfusion flow rate. However, the model has not been adapted to the data collected from actual surgery cases. In this study, the accuracy of MBs estimated by the proposed model was examined in four clinical cases. The results showed that the coefficient of determination between estimated MBs and the measured MBs throughout the surgeries was R2=0.558 (p<0.001). We found that the surgical treatments, such as administration of drugs, fluids and blood transfusions, increased the number of measured MBs. The coefficient of determination increased to R2= 0.8762 (p<0.001) by excluding the duration of these treatments. This result indicates that the model can estimate the number of MBs with high accuracy under the clinical environment.

Normothermic Regional Perfusion in Cardiac Transplantation: Developing a Program

<h3>Purpose</h3> Due to donor heart scarcity, heart failure patients are placed on a waitlist for transplantation. Efforts to expand the donor pool are essential to reduce waitlist mortality and add quality of life years. To increase organ utilization and transplantation our institution focused on innovations to allow DCD donor heart transplantation. Our program began utilizing DCD hearts in August 2020 as part of a clinical trial assessing direct procurement and machine perfusion technology. Following research on Normothermic Regional Perfusion (NRP) for DCD organ procurement and assessment, we established a clinical team to utilize this procurement strategy. <h3>Methods</h3> Our NRP program development was led by the Surgical Director and consisted of advanced heart failure fellows, transplant Nurse Practitioner, and transplant recovery specialists. The NRP program was developed in 4 phases. Phase 1: Research and concept development, IRB and and ethics review, and administration approval of NRP. Phase 2: NRP protocol development, donor acceptance criteria, and transportation logistics. Phase 3: Development of mobile cardio-pulmonary bypass system including supplies, specialized training, and construction of NRP procurement team consisting of five trained professionals. Phase 4: Dissemination of NRP protocols and focused education session for OPO and transplant center personnel. After completion of the first NRP heart transplant, all OPO leadership within our DSA were notified of our NRP program activation. <h3>Results</h3> The first remote NRP cardiac case was performed in May 2021 within our local DSA yielding a successful transplant. Our program year to date has completed 28 NRP procurement donor runs; yielding 20 transplants, with 8 aborted (6 did not expire, 1 decline due to quality, and 1 declined due to logistical issues). At present our program has 100% NRP transplant survival and our our annual transplant activity increased by 38%. <h3>Conclusion</h3> The structured development of an NRP program increased transplant volume with excellent short-term outcomes by utilizing previously discarded donor hearts.

Commentary: Heart transplantation from donation after circulatory death: Coming to a hospital near you

Commentary: Heart transplantation from donation after circulatory death: Coming to a hospital near you

Bifurcated Arterial Circulation for Hybrid Aortic Reconstruction: A Novel Technique.

Hybrid aortic procedures present many new challenges to the management of cardiopulmonary bypass (CPB). Reoperation or previous thoracic endovascular aortic repair (TEVAR) can further complicate these procedures, increasing the need for flexibility within the CPB system to execute multiple perfusion strategies as cases dictate. This technique describes the use of a bifurcated arterial circulation to provide both cerebral and lower body perfusion during a redo hybrid aortic arch reconstruction. The arterial line was divided into upper and lower body limbs, and connected to an 8-mm Dacron graft to the axillary artery, as well as a percutaneous 16-Fr. OptiSite femoral arterial cannula respectively. A 25-Fr. multi-stage femoral venous cannula was placed percutaneously as well. CPB was initiated utilizing both arterial cannulas with near-infrared spectroscopy and electroencephalogram to monitor the adequacy of cerebral perfusion. Moderate hypothermia of 26°C was induced and a CODA balloon (Cook Medical, Bloomington, IN) was deployed to occlude the proximal limb of a thoracic endovascular repair (TEVAR) graft; the common trunk of the debranched arch vessels was clamped proximally, allowing for simultaneous upper and lower body perfusion. Upon completion of the distal arch, the CODA balloon was removed and total body perfusion was reinitiated via central cannulation utilizing a sidearm on the arch graft.

Automatic control of blood flow rate on the arterial-line side during cardiopulmonary bypass.

The operation of the cardiopulmonary bypass (CPB) system requires skilled techniques and experience. Intraoperatively, the perfusionist needs to intermittently manipulate both of the occluders on the venous- and arterial-line sides to achieve the desired blood flow rates. To facilitate the occluder operation, we propose an automatic control system for the arterial-line side blood flow rate based on a dynamic model that addresses the relationship between the occluder operation and blood flow rate in the CPB system. The simulation results demonstrated that the proposed system was able to control the blood flow rate even when the estimation error of the model parameters was presented. Then, we implemented this control system in the CPB system and conducted an experiment to automatically control the arterial-line side blood flow rate. We confirmed that the blood flow rate on the arterial-line side could follow the manually operated venous-line side blood flow rate.Clinical Relevance--- The automatic blood flow rate control system for a cardiopulmonary bypass system, proposed in this paper, contributes to reducing the burden of occluder operation on a perfusionist.

The effect of using the minimized cardio-pulmonary bypass Systems for Coronary Artery Bypass Grafting in diabetic patients

IntroductionMultiple studies have shown a decrease in the inflammatory response with minimized bypass circuits leading to less complications and mortality rate. On the other hand, some other studies showed that there is no difference in post-operative outcomes. So, the aim of this study is to investigate the clinical benefits of using the Minimized cardiopulmonary Bypass system in Coronary Artery Bypass Grafting and its effect on postoperative morbidity and mortality in diabetic patients as one of the high-risk groups that may benefit from these systems.MethodsThis is a retrospective study that included 114 diabetic patients who underwent Coronary artery bypass grafting (67 patients with conventional cardiopulmonary bypass system and 47 with Minimized cardiopulmonary bypass system). The patients’ demographics, intra-operative characteristics and postoperative complications were compared between the two groups.ResultsCoronary artery bypass grafting was done on a beating heart less commonly in the conventional cardiopulmonary bypass group (44.78% vs. 63.83%, p = 0.045). There was no difference between the two groups in blood loss or transfusion requirements. Four patients in the conventional cardiopulmonary bypass group suffered perioperative myocardial infarction while no one had perioperative myocardial infarction in the Minimized cardiopulmonary bypass group. On the other hand, less patients in the conventional group had postoperative Atrial Fibrillation (4.55% vs. 27.5%, p = 0.001). The requirements for Adrenaline and Nor-Adrenaline infusions were more common the conventional group than the Minimized group.ConclusionThe use of conventional cardiopulmonary bypass for Coronary Artery Bypass Grafting in diabetic patients was associated with higher use of postoperative vasogenic and inotropic support. However, that did not translate into higher complications rate or mortality.

Hemolysis Testing In Vitro: A Review of Challenges and Potential Improvements.

Many medical devices such as cardiopulmonary bypass systems, mechanical heart valves, or ventricular assist devices are intended to come into contact with blood flow during use. In vitro hemolysis testing can provide valuable information about the hemocompatibility of prototypes and thus help reduce the number of animal experiments required. Such tests play an important role as research and development tools for objective comparisons of prototypes and devices as well as for the extrapolation of their results to clinical outcomes. Therefore, it is important to explore and provide new ways to improve current practices. In this article, the main challenges of hemolysis testing are described, namely the difficult blood sourcing, the high experimental workload, and the low reproducibility of test results. Several approaches to address the challenges identified are proposed and the respective literature is reviewed. These include the replacement of blood as the "shear-sensitive fluid" by alternative test fluids, the replacement of sparse, manual sampling and blood damage assessment by a continuous and automated monitoring, as well as an analysis of categories and causes of variability in hemolysis test results that may serve as a structural template for future studies.

Functional brain isolation technique for stroke prevention in thoracic endovascular aortic repair.

To prevent embolic stroke during thoracic endovascular aortic repair, we have adopted the brain isolation technique since June 2014 in 9 selected high-risk patients (9/134: 6.7%) having ulcerated or protruding atheromas within the proximal aorta. Cardiopulmonary bypass was used to prevent aortic atheromas from entering the brain. We used a heparin-coated closed-loop cardiopulmonary bypass system incorporating a soft reservoir bag with 1 mg/kg heparin to minimize the disadvantages of extracorporeal circulation. The bypass graft (right axillary-left carotid-left axillary) was used as an arterial inflow in patients undergoing zone-1 landing (n = 8), while peripheral cannulation into 3 brachiocephalic arteries was employed in the remaining patient. Initial pump flow was set at 1.3 l/min/m2, and native cardiac output was reduced by adjusting the reservoir bag volume. Aortography was performed to confirm non-visualization of the arch vessels before catheter manipulation. There was no mortality and 1 solitary left cerebellar infarction.

Abstract 14857: Outcomes of Bloodless Congenital Cardiac Surgery on Cardiopulmonary Bypass

Introduction: Bloodless cardiac surgery defined as blood transfusion-free open-heart surgery, where cardiopulmonary bypass (CPB) circuits primed with crystalloid only and no intraoperative blood transfusion. Limited data have been published in this field. Hypothesis: We asked whether blood conservative surgery is feasible in congenital heart disease. Methods: We retrospectively reviewed patients who underwent bloodless cardiac surgery for congenital heart disease on CPB between January 2016 and December 2018. Our unique CPB system utilizes assisted venous drainage, bioactive coating, and reduced tubing size to decrease priming volume, and complement activation. Results: A total of 164 patients were reviewed (86 male and 78 female) at a median age of 9.6 years (range, 13 months-55 years), weight of 32 kg (IQR, 16-55), preoperative hemoglobin 13.7 g/dl (IQR, 12.6-14.9), and preoperative hematocrit of 40.3% (IQR, 37.2-44.3). Median CPB time was 81.5 minutes (IQR, 58-125), and median hematocrit coming off CPB was 26% (IQR, 23-29.7). Congenital Heart Surgery risk (STAT) category distributed in STAT 1 for 70 (43%), STAT 2 for 80 (49%), STAT 3 for 9 (5%), and STAT 4 for 5 (3%) of the patients. The majority (95%) of patients were extubated in the operating room with low complications rate during the hospital stay (7%). Only 6 (4%) patients needed a blood transfusion in the postoperative period with higher incidence of complications during the hospital course (LR 14.9; p&lt;0.001). The median length of hospital stay was 3.6 days (IQR 2.6-5.6). There was no in-hospital mortality or 30 days mortality after surgery. Conclusions: Bloodless congenital cardiac surgery has a high success rate in selected low to medium surgical risk and even higher risk patients (STAT 3 and 4). Our patients had a low rate of complications and short hospital course. The blood product transfusion correlated significantly with a higher rate of complications during the postoperative course.

Impact of miniaturized cardiopulmonary bypass circuits on ultrafiltration during congenital heart surgery.

To investigate whether the miniaturized cardiopulmonary bypass (CPB) system decreased the usage of ultrafiltration (UF), and to explore whether the non-UF with miniaturized CPB strategy could get good clinical results during congenital heart surgery. We performed a retrospective analysis of all patients undergoing congenital heart surgery with CPB at Shenzhen Children's Hospital from 1 May 2015 to 30 September 2019. We classified patients to UF with miniaturized CPB group, non-UF with miniaturized CPB group, UF with conventional CPB group and non-UF with conventional CPB group. Of the 2145 patients, 721 (33.6%) were in the conventional CPB group, and 1424 (66.4%) were in the miniaturized CPB group. The UF rate was significantly lower in the miniaturized CPB group compared with that in the conventional CPB group (12.5% vs. 76.8%, p < 0.001). Compared with patients in the other groups, patients in the non-UF with miniaturized CPB group had a shorter postoperative MV time (p < 0.05), and a shorter length of stay in the ICU (p < 0.001) and hospital (p < 0.001). The age of children in the UF with miniaturized CPB group was relatively younger (median: 1.5 months, IQR: 0.3-4.6 months), and the preoperative weight was relatively lower (median: 3.9 kg, IQR: 3.2-5.4 kg). Moreover, this group of children had a relatively longer postoperative MV time and length of stay in the ICU and hospital. The miniaturized CPB system could decrease the usage of UF. Good results were achieved in children who did not use UF based on the miniaturized CPB circuit system during congenital heart surgery.

A comparative study of interleukin 6 and 17 serum levels in patients undergoing coronary artery bypass surgery using off-pump and on-pump methods

Introduction: This study aims to investigate the role of coronary artery bypass graft (CABG) surgery by off-pump and on-pump methods in the severity of postoperative inflammation based on serum levels of interleukin 6 (IL6) and interleukin 17 (IL17). Methods:This is a cross-sectional study in which 39 patients’ candidate for CABG were evaluated in terms of serum levels of IL17 and IL6 before and after surgery in two groups of off-pump and on-pump CABG.Results:Thirty-nine patients with an average age of 63±8.9 in the on-pump group and 59±7.74 in the off-pump group were evaluated. There was no significant difference between the two groups in terms of baseline information and underlying diseases. IL6 serum level (p=0.249) was not significantly difference between the two groups. However, IL17 serum level (p=0.012) demonstrated a significant difference between the two groups.Conclusion:In general, the results of this study showed that increased IL6 serum level following coronary artery bypass was not different between the two methods of CABG surgery. Besides, IL17 exhibited a significant difference between the two groupsi that it was reduced in on-pump group in after surgery. It can be due to special condition’s patients or low sample size of study. Moreover, the postoperative complications were not significantly different between the two groups. This valuable outcome contradicts the popular belief that the use of the CARDIO PULMONARY BYPASS (CPB) system stimulates the immune system and hence its application should be limited.

Development of a real-time blood damage monitoring device for cardiopulmonary bypass system using near-infrared spectroscopy.

The optical properties of hemoglobin could indicate the degree of hemolysis. We aimed to utilize this to develop a real-time blood damage monitoring device for cardiopulmonary bypass (CPB) systems. The real-time blood damage monitoring device comprised a near-infrared spectroscopy optical module with a fiber spectrometer and monitoring platform and computer software developed using LabVIEW 2017. The fiber spectrometer operated at wavelengths of 545, 660, and 940nm and contained a detector fiber bundle (source-detector distance = 1.0-2.5cm). CPB operation was simulated using an artificial heart-lung machine with a flow rate of 3, 4, or 5L/min. Four hundred milliliter of anticoagulated porcine blood was continuously rotated for 4h. The transmittance, reflectivity, and absorbance of the blood were measured using the optical device at a frequency of 25Hz and then digitally averaged into 1-s interval. Samples of damaged blood were collected at regular intervals for in vitro hemolysis tests to calculate the normalized index of hemolysis (NIH). All experiments were repeated three times. We prepared 28 blood bags containing 400ml of anticoagulant. Paired t test was used to examine the test-retest reliability of the differences between the three methods and control samples. Statistical tests revealed significant differences in the mean values between the test and control groups over time (P< 0.01). Relationship was established between the real-time monitoring results and the NIH values. An effective blood damage detection method that combined in vitro hemolysis tests and near-infrared spectroscopy was achieved. The results demonstrate the clinical potential of a real-time, low-cost, and reliable blood damage monitoring device to improve the safety of CPB operation.