[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550259":3},{"organization":4,"armGroups":7,"interventions":34,"overallOfficials":41,"centralContacts":46,"locations":10,"responsibleParty":56,"collaborators":10,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":10,"enrollmentInfo":69,"targetDuration":72,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":82,"whyStopped":10,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":10},{"fullName":5,"class":6},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","OTHER",[8,14,18,22,26,30],{"label":9,"type":10,"description":11,"interventionNames":12},"ICU patients who receive a transfusion without lung injury",null,"Purpose: This group is critical for comparing the baseline effects of blood transfusion on the proteome in critically ill patients who do not develop lung injury Following transfusion, providing a control to differentiate between transfusion-related changes in the blood composition and the specific lung injury observed in TRALI. Understanding these changes will help identify biomarkers and mechanisms exclusive to TRALI. Research question: How do transfusion-related proteomic changes manifest in ICU patients who do not develop lung injury after transfusion, and how does this baseline differ from the proteomics of TRALI patients?",[13],"Other: Blood sample collection",{"label":15,"type":10,"description":16,"interventionNames":17},"ICU patients who receive a transfusion and have indirect ARDS","Purpose: By excluding patients with ARDS due to a pulmonary cause, this group isolates systemic, non-pulmonary factors that trigger lung injury from local pulmonary responses.\n\nComparing this with TRALI helps us pinpoint unique biomarkers and understand the role of plasma proteins and various cellular-pathways dealing with systemic inflammation with concomitant lung injury. Research question: What distinct proteomic profiles and cellular pathways in non-pulmonary ARDS are observed in comparison with TRALI?",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"ICU patients who receive a transfusion and have infectious pneumonia","Purpose: Since both TRALI and pneumonia involve lung injury, understanding the differences in these responses will provide insight into the mechanisms responsible for lung inflammation in TRALI, distinguishing it from the lung inflammation caused by local pulmonary infection.\n\nResearch question: Can we differentiate between the immune and proteomic responses in localized infectious lung injury and transfusion-induced TRALI, exposing how the immune system reacts to an infection versus a transfusion event?",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"ICU patients without transfusion and with indirect ARDS","Purpose: This group allows us to characterize the proteomic and immunological responses of ARDS independent of transfusion events. This comparison with TRALI aids in the identification of changes solely due to transfusion-induced acute lung injury. Research question: What are the unique blood signatures in indirect ARDS patients when transfusion factors are removed from the equation?",[13],{"label":27,"type":10,"description":28,"interventionNames":29},"Patients without transfusion and with infectious pneumonia","Purpose: Including this group clarifies the distinction between changes driven by infection and those unique to transfusion. By subtracting the effects of infectious responses, we can confirm that biomarkers are related specifically to TRALI. ABR 86798 CURIE study Version 5,April, 2025 16 of 35 Research question: How do the inflammatory cell and protein responses to localized lung infections compare to those induced by TRALI, ensuring biomarkers identified are specific to transfusion-related injury?",[13],{"label":31,"type":10,"description":32,"interventionNames":33},"Healthy volunteers","Purpose: The inclusion of healthy volunteers in this study is crucial. They provide a baseline of normal physiological and immunological steady-state composition of the blood, allowing us to identify biomarkers specific to TRALI and the other patient subgroups by accounting for baseline variability. This group serves as a valuable control for confounding factors such as critical illness (for which ICU admission), or pre-existing lung injury or concomitant systemic inflammation including the lung (ARDS), which might otherwise obscure the identification of TRALI-specific changes. This enhances data analysis and provides clarity in distinguishing potentially unique pathophysiologic mechanisms in TRALI.\n\nResearch question:\n\nWhat baseline levels of protein, immune, and cellular profiles in healthy individuals differ from those in ICU patients undergoing transfusion, particular in terms of neutrophil activity, Treg function, and overall inflammation",[13],[35],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Blood sample collection","Blood samples of 30 mL will be collected at admission. For the groups that receive a blood transfusion an extra 30 mL blood sample will be collected.",[31,15,19,9,23,27],[40],"Blood draw",[42],{"name":43,"affiliation":44,"role":45},"Alexander Vlaar, Professor","Amsterdam UMC","PRINCIPAL_INVESTIGATOR",[47,52],{"name":48,"role":49,"phone":50,"phoneExt":10,"email":51},"Isabella Viegen, Bsc","CONTACT","+31 20 566 3311","i.viegen@amsterdamumc.nl",{"name":53,"role":49,"phone":54,"phoneExt":10,"email":55},"Anna-Linda Peters, MD\u002FPhD","+31 20-566 9111","a.l.peters@amsterdamumc.nl",{"type":45,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"A.P.J. Vlaar","Head of department of Intensive Care Medicine","100550259","comparison-of-the-proteome-in-icu-patients-in-search-for-trali-biomarkers-a-case-control-study-using-both-retrospective-and-prospective-samples-100550259",false,"NCT06444750","Comparison of the Proteome in ICU Patients in Search for TRALI Biomarkers: A Case-control Study Using Both Retrospective and Prospective Samples","CURIE","Inclusion criteria\n\nPatients on the ICU:\n\n1. Without lung injury who received a red blood cell (RBC) or platelet transfusion (PLT).\n2. With indirect ARDS with and without a blood transfusion (RBC or PLT);\n3. With pneumonia, with and without a blood transfusion (RBC or PLT).\n\nExclusion criteria\n\n1. \"Objection to registration of data for scientific use\" as noted in the patient file.\n2. Patients in whom it is impossible to obtain blood samples.\n3. Patients with massive hemorrhage.\n4. Patients with ARDS due to multiple transfusions.",true,"ALL","18 Years",{"count":70,"type":71},210,"ESTIMATED","30 Days","OBSERVATIONAL","Transfusion-related acute lung injury (TRALI) is a severe complication of blood transfusions. After a transfusion, TRALI develops in 0.08-15% of cases depending on the characteristics of the studied population. Due to preventive measures the incidence has decreased. However, the incidence of TRALI is 50-100 times higher in critically ill patients compared to the general hospital population. Since the absolute incidence of respiratory transfusion complications is low and TRALI is under-diagnosed and - reported, to this date is has not been possible to elucidate the exact pathophysiology of TRALI. Consequently, no biomarkers are yet known to detect TRALI. This study aims to identify TRALI biomarkers, gain insight in cellular pathways underlying TRALI development and the role of neutrophils and regulatory T cells, which could enhance transfusion safety.",[76,77],"Transfusion-Related Acute Lung Injury","ARDS, Human",[76,79,80,81],"Proteomics","Intensive Care Unit","Critical Ill patients","NOT_YET_RECRUITING","2025-08-27",{"date":85,"type":86},"2025-09-04","ACTUAL",{"date":88,"type":71},"2025-12",{"date":90,"type":71},"2027-05",{"name":5,"class":6}]