[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100453801":3},{"organization":4,"outcomesModule":7,"designInfo":80,"detailedDescription":84,"studyPopulation":85,"armGroups":86,"interventions":92,"overallOfficials":97,"centralContacts":102,"locations":112,"responsibleParty":131,"collaborators":134,"id":138,"slug":81,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":81,"eligibilityCriteria":143,"healthyVolunteers":139,"sex":144,"minAge":145,"maxAge":146,"enrollmentInfo":147,"targetDuration":81,"studyType":150,"phases":81,"briefSummary":151,"conditions":152,"keywords":81,"overallStatus":115,"whyStopped":81,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"University of Maryland, Baltimore","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":34,"otherOutcomes":51},[9,13,15,17,20,22,24,26,28,30,32],{"measure":10,"description":11,"timeFrame":12},"Hemolysis","Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron","Change from baseline at hour 1 during procedure",{"measure":10,"description":11,"timeFrame":14},"Change from baseline at hour 2 during procedure",{"measure":10,"description":11,"timeFrame":16},"Change from baseline at hour 3 during procedure",{"measure":10,"description":18,"timeFrame":19},"Change in Measure hemoglobin released into plasma (pfH), lactate dehydrogenase and iron etc.\n\nChange from Baseline at Hour 1 during procedure","Change from baseline at hour 4 during procedure",{"measure":10,"description":18,"timeFrame":21},"Change from baseline at hour 4 post procedure",{"measure":10,"description":18,"timeFrame":23},"Change from baseline at hour 2 post procedure",{"measure":10,"description":18,"timeFrame":25},"Change from baseline at hour 24 post procedure",{"measure":10,"description":18,"timeFrame":27},"Change from baseline on day 2 post procedure",{"measure":10,"description":18,"timeFrame":29},"Change from baseline on day 3 post procedure",{"measure":10,"description":18,"timeFrame":31},"Change from baseline on day 4 post procedure",{"measure":10,"description":18,"timeFrame":33},"Change from baseline on day 5 post procedure",[35,38,39,40,41,42,43,45,47,49],{"measure":36,"description":37,"timeFrame":12},"Kidney injury","Change in creatinine, KIM-1 and NGAL",{"measure":36,"description":37,"timeFrame":14},{"measure":36,"description":37,"timeFrame":16},{"measure":36,"description":37,"timeFrame":19},{"measure":36,"description":37,"timeFrame":23},{"measure":36,"description":37,"timeFrame":25},{"measure":36,"description":37,"timeFrame":44},"Change from baseline at 2 days post procedure",{"measure":36,"description":37,"timeFrame":46},"Change from baseline at 3 days post procedure",{"measure":36,"description":37,"timeFrame":48},"Change from baseline at 4 days post procedure",{"measure":36,"description":37,"timeFrame":50},"Change from baseline at 5 days post procedure",[52,55,56,57,58,59,60,62,64,66,68,71,72,73,74,75,76,77,78,79],{"measure":53,"description":54,"timeFrame":12},"Blood cell function","CBC and red blood cell deformability",{"measure":53,"description":54,"timeFrame":14},{"measure":53,"description":54,"timeFrame":16},{"measure":53,"description":54,"timeFrame":19},{"measure":53,"description":54,"timeFrame":23},{"measure":53,"description":54,"timeFrame":25},{"measure":53,"description":54,"timeFrame":61},"Change from baseline at day 2 post procedure",{"measure":53,"description":54,"timeFrame":63},"Change from baseline at day 3 post procedure",{"measure":53,"description":54,"timeFrame":65},"Change from baseline at day 4 post procedure",{"measure":53,"description":54,"timeFrame":67},"Change from baseline at day 5 post procedure",{"measure":69,"description":70,"timeFrame":12},"Outcome Hemoglobin Clearance","Change in hemoglobin clearance measured by plasma haptoglobin and transferrin concentrations",{"measure":69,"description":70,"timeFrame":14},{"measure":69,"description":70,"timeFrame":16},{"measure":69,"description":70,"timeFrame":19},{"measure":69,"description":70,"timeFrame":23},{"measure":69,"description":70,"timeFrame":25},{"measure":69,"description":70,"timeFrame":61},{"measure":69,"description":70,"timeFrame":63},{"measure":69,"description":70,"timeFrame":65},{"measure":69,"description":70,"timeFrame":67},{"allocation":81,"interventionModel":81,"interventionModelDescription":81,"primaryPurpose":81,"observationalModel":82,"timePerspective":83,"maskingInfo":81},null,"COHORT","PROSPECTIVE","Cost estimates for brain, lung, cardiac, and kidney complications following complex cardiac surgeries that require a medical assist device to by-pass the heart and lungs (cardiopulmonary bypass, CPB) is estimated to cost $80 million per individual states in the US over a ten-year period. These extra costs represent a significant burden on the healthcare system but could be reduced by understanding how medical assist devices lead to organ injury associated with complex cardiac surgeries. The primary goals of this research are to (1) understand how hemoglobin released into plasma (pfH) from damaged red blood cells that passage through CPB contributes to organ injury. (2) Determine the amount of pfH necessary to cause organ injury. (3) Determine the concentration changes in protective proteins (called haptoglobin, hemopexin and transferrin) that remove pfH and its degradation products from the circulation. (4) Design a computer-based model that will determine the levels of pfH and protective proteins to predict the potential for organ injury. By studying the dynamics of red blood cell lysis, pfH, protective proteins and organ injury limits will be set for safe levels of pfH following the use of CPB. These results will be compared to existing laboratory-based methods for determining red blood cell damage to predict CPB assist device safety. Further, results from the studies described in this proposal will help develop therapeutic strategies to benefit patients by early detection of pfH and clearance protein levels that occur during CPB. The primary goals of this research are to (1) understand how hemoglobin released into plasma (pfH) from damaged red blood cells that passage through CPB contributes to organ injury. (2) Determine the amount of pfH necessary to cause organ injury. (3) Determine the concentration changes in protective proteins (called haptoglobin, hemopexin and transferrin) that remove pfH and its degradation products from the circulation. (4) Design a computer-based model that will determine the levels of pfH and protective proteins to predict the potential for organ injury. By studying the dynamics of red blood cell lysis, pfH, protective proteins and organ injury limits will be set for safe levels of pfH following the use of CPB. These results will be compared to existing laboratory-based methods for determining red blood cell damage to predict CPB assist device safety. Further, results from the studies described in this proposal will help develop therapeutic strategies to benefit patients by early detection of pfH and clearance protein levels that occur during CPB.","Research Participants will include approximately 90 adult (\\>\u002F=18 years of age to 75 years of age) medium to high risk patients. Both Male and female subjects who are undergoing complex cardiac surgery requiring, heart valve replacement, or CABG surgery requiring cardiopulmonary bypass \\>1hr will be eligible for enrollment at the University of Maryland Medical Center (UMMC) in Baltimore, MD. This study is a prospective observational investigation.",[87],{"label":88,"type":81,"description":89,"interventionNames":90},"Cardiac Sugery Patients Requiring Cardiopulmonary >1hour","Patients admitted for a complex cardiac surgery, heart valve replacement and\u002For CABG surgery requiring CPB \\>1hour",[91],"Other: Blood and urine collection",[93],{"type":6,"name":94,"description":95,"armGroupLabels":96,"otherNames":81},"Blood and urine collection","No intervention - Biological specimen collection",[88],[98],{"name":99,"affiliation":100,"role":101},"Paul Buehler, PhD","University of Maryland","PRINCIPAL_INVESTIGATOR",[103,108],{"name":104,"role":105,"phone":106,"phoneExt":81,"email":107},"Paul W Buehler, PhD","CONTACT","14107065171","pbuehler@som.umaryland.edu",{"name":109,"role":105,"phone":110,"phoneExt":81,"email":111},"Tobi Rowden, RN","4107064061","trowden@som.umaryland.edu",[113],{"facility":114,"status":115,"city":116,"state":117,"zip":118,"country":119,"countryCode":120,"cosmosGeoPoint":121,"geoPoint":126,"contacts":127},"Center for Blood Oxygen Transport and Hemostasis","RECRUITING","Baltimore","Maryland","21201","United States","US",{"type":122,"coordinates":123},"Point",[124,125],-76.61219,39.29038,{"lat":125,"lon":124},[128,130],{"name":104,"role":105,"phone":129,"phoneExt":81,"email":107},"410-706-5171",{"name":109,"role":105,"phone":110,"phoneExt":81,"email":111},{"type":101,"investigatorFullName":132,"investigatorTitle":133,"investigatorAffiliation":5,"oldNameTitle":81,"oldOrganization":81},"Paul Buehler","Research Faculty",[135],{"name":136,"class":137},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100453801",false,"NCT05189262","Cardiopulmonary Bypass Induced Red Blood Cell Lysis","Extra-Cellular Hemoglobin, Organ Injury in Extended Cardiopulmonary Bypass","Inclusion Criteria:\n\n* Admitted to UMMC for cardiac procedure\n* Age: \\>\u002F=18 y.o TO 88 y.o.\n* Undergoing CPB \\>1hr for the following surgeries (a) complex cardiac surgery (b) heart valve replacement surgery OR (c) CABG surgery.\n\nExclusion Criteria:\n\n* Pregnant\n* Non English speaking\n* Unable to consent or have Legally Authorized Representative (LAR) assent to study","ALL","18 Years","88 Years",{"count":148,"type":149},150,"ESTIMATED","OBSERVATIONAL","Studying the dynamics of red blood cell lysis, pfH, protective proteins and organ injury, limits will be set for safe levels of pfH following the use of CPB. These results will be compared to existing laboratory-based methods for determining red blood cell damage to predict CPB assist device safety. Further, results from the studies described in this proposal will help develop therapeutic strategies to benefit patients by early detection of pfH and clearance protein levels that occur during CPB.",[153,154,155],"Cardiopulmonary Bypass","Cardiac Surgery","Kidney Injury, Acute","2025-08-13",{"date":158,"type":159},"2025-08-19","ACTUAL",{"date":161,"type":159},"2022-03-22",{"date":163,"type":149},"2027-12-01",{"name":5,"class":6},1]