Clinical trials

Patients with with recurrent or progressive medulloblastoma, ependymoma, atypical teratoid rhabdoid tumor (ATRT), and CNS tumors of various histologies have a very poor prognosis whether treated with conventional chemotherapy, high-dose chemotherapy with stem cell rescue, irradiation or combinations of these modalities. Antiangiogenesis therapy has emerged as a new treatment option in solid malignancies. The frequent delivery of low doses of chemotherapy, referred to as metronomic or antiangiogenic chemotherapy, targets endothelial cells while reducing the toxicity associated with standard dose chemotherapy. The aim of the study is to extend therapy options for children with recurrent or progressive medulloblastoma, ependymoma, ATRT, and CNS tumors of various histologies, for whom no known curative therapy exists, by prolonging survival while maintaining good quality of life. The study will be conducted in independent strata. Stratum I (recurrent medulloblastoma): recently completed (Peyrl, 2023). Stratum II (recurrent ependymoma), III (recurrent ATRT) and V (recurrent CNS tumors of various histologies, patients with exclusion criteria and adult patients): The primary objective is to determine the response rate defined as the percentage of patients with complete response (CR), partial response (PR), stable disease (SD) or lack of recurrence at 6 months after start of antiangiogenic treatment. Stratum IV (recurrent medulloblastoma): To determine whether temozolomide, irinotecan, bevacizumab, thalidomide, celecoxib, fenofibrate, etoposide ivt, cytarabine ivt can increase the response rate after 6 months of treatment, compared with etoposid, cyclophosphamide, bevacizumab, thalidomide, celecoxib, fenofibrate, etoposide ivt, cytarabine ivt. Additionally, PFS, OS, toxicity, QoL, performance status, predictive and prognostic markers will be examined. In stratum II and III, the study will follow an open label, single arm phase 2 design, and an open label randomized two-arm phase 2 design in Stratum IV, and the exploratory Stratum V.

Parathyroid insufficiency is a common complication in thyroid surgery and occurs in 6.6 to 24%. Up to 4.4% suffer from permanent hypoparathyroidism requiring life-time substitution of calcium and vitamin D in order to maintain a normal calcium homeostasis. To prevent permanent postoperative parathyroid insufficiency after thyroidectomy, devascularized parathyroid glands are re-implanted intramuscularly by standard. To achieve graft function, meticulous preparation and division of parathyroid tissue is necessary as a prerequisite for tissue nutrition by diffusion until a recapillarization of the parathyroid fragments sets in. There are persistent controversies about the optimal technique for the autotransplantation. The injection of mashed parathyroid tissue into a muscle appears to be a fast, secure and easy tech-nique to provide a sufficient parathyroid hormone (PTH) production in cases of insufficient production of the glands left in-situ. The study is based on the hypothesis that intramuscular injection of mashed parathyroid tissue is a safe procedure that enables graft survival through diffusion and allows for the subsequent production of systemically measurable levels of parathyroid hormone (PTH). The intervention consists of injecting mashed parathyroid tissue into the brachioradialis muscle of the non-dominant arm. The primary objective is to evaluate this technique with respect to both local complications arising from the transplantation procedure and the functional performance of the graft over time. Outcome measures include the PTH gradient between the transplanted and non-transplanted arms, parathyroid hormone levels measured in the antecubital fossa of both arms, and calcium levels. The study population comprises 100 patients, and the trial is designed as a prospective multicentre study. The risk-benefit assessment indicates that the risks associated with participation-particularly local complications and potential graft malfunction-are expected to be low. In patients with familial or renal hyperparathyroidism, autotransplantation of small parathyroid fragments (approximately 1 mm in diameter) has been standard practice for decades. Additionally, the injection of mashed parathyroid tissue into the sternocleidomastoid muscle during surgery has been performed in many centers for years. However, that approach has the limitation that PTH originating from the graft cannot be reliably measured due to anatomical constraints.

Carbon dioxide in patients on veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is eliminated via respirator as well as via the oxygenator's membrane of the ECMO machine. Consequently, monitoring of end-tidal carbon dioxide tensions is limited, which can result in marked swings towards non-physiological values. Hyper- and hypocapnia, however, can have detrimental effects on organ perfusion in a great number of patients supported with VA-ECMO. Continuous, rapidly applicable monitoring of reliable carbon dioxide measures would therefore be extremely helpful to prevent harmful deviations from the norm. The investigators therefore try to assess the accuracy and the precision of continuously measured non-invasive transcutaneous carbon dioxide partial pressures when compared with tensions determined by blood gas analysis.

The MethMax trial is a prospective, international, multicentre, randomised, assessor-blinded, parallel-group, low intervention study. Patients with active rheumatoid arthritis treated with oral methotrexate up to 25 mg weekly will be randomised in 50:50 fashion to receive 25 mg oral vs subcutaneous methotrexate for the period of 24 weeks. In regular visits, patient reported outcomes, clinical disease activity, therapy adherence and diverse established and exploratory biomarkers will be assessed.

The aim of this randomized study is to compare a live, trained simulated patient with a high-fidelity manikin in obstetric emergency team training using two standardized scenarios. The participants in this study are intact clinical teams (e.g., obstetrics, anesthesiology, and nursing/midwifery staff routinely working together in obstetric emergencies) and are recruited as a unit. Each team will either have both scenarios with the live, trained standard patient or the high fidelity manikin. Both scenarios are standardized: One scenario is about post-partum hemorrhage (PPH), a severe bleeding after giving birth, and the other scenario is about eclampsia, an emergency in obstetrics that causes hypertensive crisis and seizures. The order of scenarios is random. After each scenario all team members fill out questionnaires about realism and cognitive stress. After the second debriefing, a focus group of approximately 15 minutes is conducted with each team with a standardized procedure and questions.

Endometriosis is a chronic inflammatory disease affecting approximately 10% of women in their reproductive years. It is characterized by the presence of endometrial-like tissue outside the uterine cavity. Current treatment options include hormonal therapies or surgical excision of the endometriotic lesions. Although these interventions often lead to a significant symptom relief, some patients still experience persistent pain or treatment-related adverse effects. Consequently, the management of dysmenorrhea and improvement of quality of life in patients with endometriosis remain a clinical challenge. Desloratadine is widely used for the treatment of allergic rhinitis or chronic urticaria. Recent studies suggest that desloratadine may also possess analgesic and anti-inflammatory properties. So far, however, no clinical studies have investigated its potential therapeutic effects in patients with endometriosis. Therefore, the present study aims to provide the first clinical assessment of the efficacy, safety and tolerability of desloratadine in patients with endometriosis.

Dry eye disease can occur or worsen after cataract surgery and may cause ocular discomfort and reduced visual quality. Standard treatment commonly includes artificial tear eye drops, which provide temporary lubrication. Temporary occlusion of the tear drainage system may offer an alternative approach by increasing tear retention and improving tear film stability. This prospective, randomized, double-blind, inter-eye study will evaluate the use of LACRIFILL® Canalicular Gel, a crosslinked hyaluronic acid gel placed in the tear drainage system, in patients who have undergone bilateral cataract surgery. Treatment allocation will be randomized at the eye level within each participant. One eye will be assigned to treatment with LACRIFILL®, while the fellow eye will serve as the control and receive standard care with artificial tear eye drops. The study will compare the development and severity of dry eye disease between the randomized treatment and control eyes. The main outcome will be tear production measured by the Schirmer Test 1 one month after treatment. Additional assessments will include tear film stability, ocular surface findings, anterior segment imaging, visual quality, dry eye symptoms, use of artificial tears, and treatment-related safety outcomes during a three-month follow-up period.

The aim of this clinical study is to evaluate a toric add-on intraocular lens (IOL) for the correction of high astigmatism in patients who have undergone keratoplasty and cataract surgery. As this patient group often suffers from significant preoperative residual astigmatism, there is a relevant clinical need for effective and safe refractive treatment options. The implantation of a toric add-on IOL in the ciliary sulcus is intended to significantly reduce postoperative astigmatism and improve visual rehabilitation. The study is designed as a prospective, monocentric clinical trial with a limited number of cases, as this is a rare condition with limited availability of suitable patients. It is being conducted in accordance with Section 3 of the Austrian Medical Devices Act (MPG 2021) and is investigating a CE-marked add-on intraocular lens implant used within its intended purpose. The postoperative refractive cylinder serves as the primary endpoint, as it reflects the actual effectiveness of astigmatism correction. The rotational stability of the add-on IOL, which significantly influences refractive precision, is recorded as a secondary endpoint. All study participants will be examined pre- and postoperatively in accordance with applicable medical standards. The results should contribute to the optimization of refractive care after keratoplasty and assess the clinical applicability of toric AddOn IOLs in this specific indication.

This investigator-initiated, single-arm, open-label Phase IIa pilot study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of OM336 in highly HLA-sensitized adults with chronic kidney disease awaiting kidney transplantation. The study will enroll 12 participants who have either a very low likelihood of receiving a compatible deceased donor kidney because of broad HLA sensitization or unacceptable donor-specific antibodies against a potential living donor. Participants will receive one 4-week course of subcutaneous OM336, with the option of a second 4-week course based on the change in virtual panel-reactive antibody (vPRA) levels after the initial treatment period. Participants will subsequently be followed for up to 24 months and, if transplantation occurs, for at least 12 months after transplantation. The primary objectives are to evaluate the safety and tolerability of OM336 through Week 24 and (co-primary endpoint) its effect on HLA sensitization, assessed by changes in vPRA levels at Week 24. Secondary and exploratory objectives include assessment of the durability of changes in vPRA and donor-specific antibodies, the number of potential compatible donors, transplantation rates, OM336 pharmacokinetics and immunogenicity, and effects on B-cell and plasma-cell immunity and antibody characteristics. An optional substudy will assess B-cell immunity in bone marrow and lymph-node samples.

Post-Intensive Care Syndrome (PICS) refers to long-term cognitive, physical, and psychological impairments that can arise after intensive care treatment. These symptoms may begin within 24 hours of ICU admission and persist for years. Affected patients and their families (PICS-F) face significant burdens, with up to 94% of relatives impacted. Given its high prevalence and socioeconomic impact, this prospective registry study aims to identify risk factors and long-term consequences of PICS and PICS-F. The study consists of six modules, starting with data collection during ICU stays and continuing with follow-ups at various intervals post-discharge (up to five years). The primary goal is to investigate diagnostic and therapeutic strategies, while secondary objectives include identifying risk factors, determining impairment severity, and exploring biological mechanisms. Standardized questionnaires and biological samples (blood) are used for data collection.

Shoulder dystocia is an unpredictable, time-critical obstetric emergency requiring immediate recognition and rapid execution of established maneuvers. To date, there is no published evidence evaluating remote real-time support for the management of shoulder dystocia, which could be especially relevant for providers not frequently confronted with obstetric emergencies. This prospective, randomized, controlled, simulation-based trial compares healthcare providers' performance in managing a standardized shoulder dystocia scenario when supported by remote tele-assistance versus a standard cognitive aid. Teams of at least two healthcare providers manage a standardized scenario on the Laerdal MamaBirthie Task Trainer, with a trained study team member playing the laboring patient. Successful delivery requires completion of three predefined external maneuvers and one internal maneuver. Teams are randomized to Group A (cognitive aid: a standardized visual reference tool with written instructions and pictograms) or Group B (remote tele-support: live video guidance from a credentialed obstetric expert via Signal). The primary outcome is the total performance score (0-25 points). Secondary outcomes include cognitive load (NASA-TLX), usability (System Usability Scale), and subjective experience and communication quality (5-point Likert scales).

Bronchopulmonary dysplasia (BPD) remains one of the most common complications in extremely preterm infants despite advances in neonatal intensive care. Early identification of infants at high risk for BPD could facilitate individualized treatment strategies and improve long-term respiratory outcomes. However, current prediction models rely primarily on conventional clinical variables and have limited predictive accuracy. This prospective observational study aims to evaluate the predictive value of novel physiological, imaging, and biomarker-based indicators for the development of BPD in infants born before 26 weeks of gestation. Participants admitted to the neonatal intensive care units of the Medical University of Vienna will undergo non-invasive assessments during routine clinical care. These include respiratory function monitoring during neonatal transition, lung ultrasound, diaphragmatic ultrasound, targeted neonatal echocardiography, forced oscillation technique, neurally adjusted ventilatory assist-derived diaphragmatic electrical activity, electrical impedance tomography, and proteomic analyses of plasma and tracheal aspirate samples. The association between these novel indicators and respiratory disease severity will be assessed using the Respiratory Severity Score (RSS). Their ability to predict BPD will be evaluated using receiver operating characteristic (ROC) analysis and uni- and multivariable logistic regression models. Predictive performance will be assessed using the C-statistics. The primary objectives are to determine the correlation between the novel indicators and the RSS and to evaluate their diagnostic accuracy for predicting BPD. Secondary objectives include identifying the combination of indicators that provides the best prediction of BPD, evaluating longitudinal changes in respiratory and cardiovascular parameters during the neonatal period, assessing the effects of respiratory interventions and treatments on these indicators, and investigating associations with survival and major neonatal morbidities. A total of 140 extremely preterm infants is planned for inclusion in the study. The results are expected to improve early risk stratification and contribute to the development of individualized strategies for preventing and managing BPD.

Patients who receive maintenance hemodialysis have a very high risk of cardiovascular disease, and standard cholesterol-lowering treatments such as statins have not been shown to reduce cardiovascular events in this group. A recent clinical trial (PISCES) found that high-dose omega-3 fatty acids (fish oil) reduced cardiovascular events in hemodialysis patients, but the reason for this benefit is not understood. One possible explanation is that, in kidney failure, high-density lipoprotein (HDL) no longer works normally. This study investigates whether omega-3 fatty acid supplementation improves the function of HDL in people on maintenance hemodialysis. Forty adults on maintenance hemodialysis will take part. Each participant receives fish oil (4 g per day) for 8 weeks and also has an 8-week period without supplementation; participants are randomly assigned to the order of these two periods (crossover design), for a total of 16 weeks each. The main measure is cholesterol efflux capacity, a laboratory test of how well HDL removes cholesterol from cells. The study also examines other markers of HDL quality. This is an exploratory, mechanistic study. Its aim is to determine whether omega-3 fatty acids change HDL function and to inform the design of larger future trials.

The main objective is to determine the short-term effect of prone positioning in infants with infection-associated severe acute respiratory distress syndrome. The investigators compare oxygenation parameters and measurements from electrical impedance tomography (EIT) and lung ultrasonography (LUS) in mechanically ventilated infants in prone position versus supine position after surfactant administration.

"Rare Diseases" is an umbrella term including more than 8.000 different diseases which individually affect only a small percentage of people. Rare diseases predominantly affect children and adolescents and are associated with high medical and psychosocial burden of disease. The investigators invented Education \& Care in RARE - a short-term, structured, resource-oriented and child-friendly psychoeducation program for children and adolescents with rare diseases. This study is a prospective, multicenter, randomized and controlled study with a waiting list. Aim of the study is to investigate the efficacy of Education \& Care in RARE on knowledge about rare diseases and on mental health well-being in pediatric rare disease patients, compared to a control group. In this study participants are randomized in an intervention group and a waiting list control group. Both study groups thus receive the psychoeducation with Education \& Care in RARE and complete the identical questionnaires. Compared to the Intervention group, the waiting list control group receives the intervention with a time delay (8-12 weeks later) and has one additional appointment for questionnaire evaluation before start of the psychoeducation.

The study focuses on regional lung examination, in particular on the differentiation between collapsed and hyperinflated lung areas. The purpose of the study is to elaborate common and discriminative elements between different lung imaging modalities in infants and to generate hypotheses for the bedside use of EIT and LUS in infants.

Interstitial fibrosis is a hallmark of progression in chronic kidney disease (CKD), yet it can presently be assessed only by kidney biopsy, which is invasive and prone to sampling error. In recent years the advances in molecular imaging, especially high spatial and temporal resolution of the scanners and the development of radiopharmaceuticals to visualize metabolic processes or immune cells have been significant, opening promising possibilities in multiple fields. It was demonstrated that in autoimmune diseases as Crohns disease the use of fibrosis markers, as 68Ga-FAPI tracer in PET/MRI could adequately reflect the amount of fibrosis found in histologic work up of tissue specimens in the gut. Also first data in small studies including patients with chronic kidney disease showed promising results indicating that tracer uptake could reflect the degree of fibrosis. This study aims to investigate the utility of PET/CT imaging with a \[68Ga\]-DOTA.SA.FAPi tracer to reflect the degree of fibrosis found in the histological work up. We hypothesize that PET/CT findings reflect histological found fibrotic changes in kidney biopsies, potentially offering a superior alternative due to its non-invasive nature and the possibility to capture the entire organ.

Acute respiratory distress syndrome (ARDS) is a major contributor to ICU mortality and is characterised by hypoxaemia and pulmonary oedema. Pathomechanisms include barrier breakdown, immunopathology, haemostatic derailment and dysbiosis; however, the actual sequence of events and how they cumulatively lead to lung failure remains unclear. Although ARDS is frequently triggered by pneumonia, it can also occur as a result of trauma, aspiration or non-pulmonary causes. Importantly, ARDS is highly heterogeneous; growing evidence points to aetiology-specific pathomechanisms - a circumstance that explains why attempts to develop specific drugs or timely diagnostic markers have so far failed. A comprehensive analysis of key microenvironmental and haemostasis-related parameters of the lung, combined with multidimensional quantitative image features derived from chest CT scans (radiomics), will enable us to i) identify ARDS phenotypes with different biological characteristics and ii) generate new hypotheses regarding aetiology- or subgroup-specific mechanisms, molecular markers and therapeutic options. Our approach is based on ICU management of our patients guided by bronchoalveolar lavage fluid (BALF). Together with previously sampled cases and new samples collected as part of this study, our cohort will consist of patients with i) COVID-19-associated ARDS, ii) ARDS associated with other viral pneumonia, iii) ARDS associated with bacterial pneumonia, and iv) ARDS of non-pulmonary origin. Bacterial and fungal co-infections and superinfections are recorded in all patients and taken into account in the stratification. Patients with pneumonia without ARDS, as well as ventilated patients without underlying lung disease, serve as controls. To characterise the microbial lung microenvironment, the investigators combine data from routine microbiological diagnostics with microbiome sequencing and metabolomics. In addition, the investigators conduct comprehensive and longitudinal immune and haemostatic profiling by regularly analysing immune cells, cytokines and parameters of immune thrombosis in BALF and blood. Multi-omics integration then identifies phenotypic subgroups by merging all multimodal datasets - including radiomics. Selected samples from identified clusters are then further characterised using single-cell sequencing to uncover specific features/markers and pathomechanisms of the respective ARDS subtypes. Although it is clear that the pathogenesis of ARDS is multifactorial, comprehensive studies that integrate all relevant parameters are rare. Radiomics is increasingly recognised as a powerful tool for capturing the clinical status of ARDS in detail; however, to date, this imaging data has not been systematically linked to other omics readouts. The investigators aim to bridging this gap by conducting a thorough investigation across various ARDS aetiologies in the present study, incorporating all identifiable key factors. Our interdisciplinary team comprises basic immunologists, infectious disease and computational biologists, as well as clinicians with expertise in ARDS, infectious diseases, immunothrombosis and radiology.

The purpose of this clinical study is to investigate the potential effects of myo-inositol supplementation on changes in glycemic control parameters, oxidative stress, inflammatory biomarkers, psychometric markers, and body composition in participants with gestational diabetes mellitus (GDM). The study duration is 3 to 3.5 months, depending on the time of GDM diagnosis. Before the active phase begins, there is a 10-day observation period during which participants' blood glucose levels are monitored using a continuous glucose monitoring device. In the subsequent 12-14-week study phase, participants will receive a supplement based on random group assignment. They will be allocated either to an intervention group (myo-inositol + folic acid) or a control group (folic acid). Both supplements will be taken until delivery. The intervention group supplement contains 4 g myo-inositol and 400 μg folic acid (BIOGENA GmbH, Salzburg) and is to be taken twice daily with water - three capsules per meal. The control group supplement contains only 400 μg folic acid (BIOGENA GmbH, Salzburg) and is also taken twice daily, one capsule per meal. As this is a pilot study, both participants and study personnel will be aware of group assignments. Blood glucose measurements will be repeated mid-study (around the 33rd week of pregnancy) and at the end (37th week of pregnancy) using glucose sensors. To improve the evaluation of glucose measurements, participants will keep dietary logs during these periods. Three study visits are planned, during which the following assessments will be conducted. To determine the primary outcome, "time in range (TIR)" (time spent within the target glucose range), three glucose sensor measurements will be performed. At each visit, blood samples will be taken to analyze glycemic control parameters (hemoglobin A1c (HbA1c), fasting glucose, fasting insulin, Homeostasis Model Assessment (HOMA-IR), insulin dosage), oxidative stress markers (total antioxidant capacity, malondialdehyde levels), and inflammatory markers (interleukin-6 (IL-6), C-reactive protein (CRP)). Anthropometric measurements (weight gain, blood pressure, pulse) and body composition (Bioelectrical Impedance Analysis) will also be performed. Additionally, maternal and fetal birth outcomes will be recorded, including cesarean section rates, fetal gestational weight, preterm birth rates, and neonatal hypoglycemia occurrence. To assess participants' well-being and physical activity, questionnaires will be distributed at the beginning and end of the study.

The goal of this observational study is to learn whether hazardous alcohol consumption, measured objectively by carbohydrate-deficient transferrin (CDT) levels at intensive care unit (ICU) admission, is associated with worse outcomes in critically ill patients. The main question it aims to answer is: Do elevated CDT levels at ICU admission predict increased short-term mortality and adverse clinical outcomes in adult non-traumatic ICU patients? Participants admitted to the intensive care unit via the emergency department will have CDT levels measured as part of the study. Researchers will then collect and analyze clinical data, including mortality, duration of mechanical ventilation, delirium, ICU length of stay, renal replacement therapy, and ICU readmission rates, during hospitalization and follow-up.

The goal of this observational study is to analyse the association between anti-factor Xa activity (antiXa) and the occurence of venous thromboembolism (VTE; either deep vein thrombosis and/or pulmonary embolism) in critically ill patients who are admitted to an intensive care unit. The main questions it aims to answer are: * What is the association between antiXa and VTE? * What is the association between antiXa and symptomatic, respectively incidental, VTE? * How is pharmacological anticoagulation with enoxaparin related to measured antiXa? * What is the association between antiXa and bleeding complications. * What is the incidence of venous thromboembolism in patients treated at an intensive care unit? * How is the occurence of VTE related to patient-centred outcomes such as mortality, quality of life, length of stay and days outside of the intensive care unit/hospital.

Patients are randomly assigned to a study group. Depending on the study group, either an arteriovenous fistula or tunneled cuffed catheter (TCC) will be implanted, followed by continuous evaluation of the patients during the first year after initiating the vascular access. The evaluation includes statistical evaluation of all events, including loss of access, thrombosis, infection, loss of patency, increase in co-morbidities, e.g. congestive heart failure as well as quality of life. The implantation of the TCC is a standard procedure and it will be used only in accordance with the approved instructions of use on subjects who have signed an informed consent form. The surgery is a standard operation and it will be performed by specialized surgeons on subjects who have signed an informed consent form (No grafts will be used; implantation of a standard TCC, used at the Department of Nephrology). Both, an arteriovenous fistula or a TCC, will be used for routine chronic haemodialysis

There is evidence that central venous catheters made of the permanent and non-eluting integral polymer Endexo® are more resistant to intraluminal thrombosis. This has a direct reducing effect on catheter malfunctions. Indirectly, due to reduced handling of the dysfunctional catheter, this may lead to a diminished rate of catheter related infections. Since catheter malfunctions and infections represent leading complications in a dialysis population, dialysis catheters produced with Endexo® technology have the potential to have beneficial clinical effects. In addition to improving patient outcomes, this could also reduce overall costs. In this pilot study the tunneled hemodialysis catheter BioFlo Duramax with Endexo® technology (Merit Medical, Utah, USA) will be compared with historical catheter dysfunction rates in standard tunneled dialysis catheters (silicone or polyurethane) in chronic dialysis population.

Patients will receive in addition to standard histology analysis also the PDC- based drug screening.

The main goal of this observational, study is to develop a clinical decision support tool utilizing Impella 5.5 pump parameters to predict native heart recovery and prevent adverse events, by leveraging data science and real-world clinical data of cardiogenic shock patients. Therefore, secondary objectives are essential to consolidating a retrospective longitudinal analysis of Impella 5.5 pump data alongside ICU digital health record datasets to: 1. Validate the Impella 5.5 placement signal by comparing it with ICU arterial line waveforms. 2. Integrate pump data with ICU clinical data to identify patterns associated with therapy outcomes, including native heart recovery, heart replacement therapy, and mortality while on device support. 3. Define clinical scenarios linked to hemolysis, HRAEs, and arrhythmias and develop predictive models to mitigate their occurrence.