[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100481202":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":44,"studyPopulation":44,"armGroups":54,"interventions":67,"overallOfficials":74,"centralContacts":78,"locations":84,"responsibleParty":103,"collaborators":106,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":44,"eligibilityCriteria":115,"healthyVolunteers":112,"sex":116,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":44,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":86,"whyStopped":44,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"University Hospitals Cleveland Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":44},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Level of Plasma Free Hemoglobin","Level of plasma free hemoglobin will be measured at baseline.","Baseline",{"measure":10,"description":14,"timeFrame":15},"Level of plasma free hemoglobin will be measured post-processing.","Post-Processing (Up to 120 Minutes)",{"measure":17,"description":18,"timeFrame":19},"Change in Volume of Blood","Volume of blood will be measured at baseline and post-processing.","Baseline, Post-Processing (Up to 120 Minutes)",[21,24,26,29,31,34,36,40],{"measure":22,"description":23,"timeFrame":12},"Number of Fragmented Red Blood Cells","Number of fragmented red blood cells will be measured at baseline.",{"measure":22,"description":25,"timeFrame":15},"Number of fragmented red blood cells will be measured post-processing.",{"measure":27,"description":28,"timeFrame":12},"Level of Lactate Dehydrogenase","Level of lactate dehydrogenase will be measured at baseline.",{"measure":27,"description":30,"timeFrame":15},"Level of lactate dehydrogenase will be measured post-processing.",{"measure":32,"description":33,"timeFrame":12},"Level of Haptoglobin","Level of haptoglobin will be measured at baseline.",{"measure":32,"description":35,"timeFrame":15},"Level of haptoglobin will be measured post-processing.",{"measure":37,"description":38,"timeFrame":39},"Change in Weight of Surgical Sponge","Weight of surgical sponges will be measured at baseline and post-procedure.","Baseline, Post-Procedure (Up to 5 Minutes)",{"measure":41,"description":42,"timeFrame":43},"Time to Wring Sponges","Time to wring sponges will be measured.","Up to 120 Minutes",null,{"allocation":46,"interventionModel":47,"interventionModelDescription":44,"primaryPurpose":48,"observationalModel":44,"timePerspective":44,"maskingInfo":49},"NON_RANDOMIZED","CROSSOVER","SUPPORTIVE_CARE",{"masking":50,"maskingDescription":51,"whoMasked":52},"SINGLE","Subjects will be blinded to the order of intervention.",[53],"PARTICIPANT",[55,61],{"label":56,"type":57,"description":58,"interventionNames":59},"Hand Wrung","ACTIVE_COMPARATOR","Hand wrung refers to manually wringing surgical sponges by hand.",[60],"Procedure: Hand Wrung",{"label":62,"type":63,"description":64,"interventionNames":65},"ProCell Wrung","EXPERIMENTAL","ProCell wrung refers to automated wringing surgical sponges by an FDA approved suction device (ProCell).",[66],"Device: ProCell Wrung",[68,71],{"type":69,"name":56,"description":58,"armGroupLabels":70,"otherNames":44},"PROCEDURE",[56],{"type":72,"name":62,"description":64,"armGroupLabels":73,"otherNames":44},"DEVICE",[62],[75],{"name":76,"affiliation":5,"role":77},"Rakesh Arora, MD","PRINCIPAL_INVESTIGATOR",[79],{"name":80,"role":81,"phone":82,"phoneExt":44,"email":83},"Jessica Hungate, MD","CONTACT","216-844-3800","Jessica.Hungate@UHhospitals.org",[85],{"facility":5,"status":86,"city":87,"state":88,"zip":89,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"RECRUITING","Cleveland","Ohio","44106","United States","US",{"type":93,"coordinates":94},"Point",[95,96],-81.69541,41.4995,{"lat":96,"lon":95},[99],{"name":100,"role":81,"phone":101,"phoneExt":44,"email":102},"Craig Jarrett, MD, MBA","216-286-7297","Craig.Jarrett@UHhospitals.org",{"type":77,"investigatorFullName":104,"investigatorTitle":105,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"Mohammad El Diasty","Division Chief, Cardiac Surgery, UH Cleveland Medical Center",[107],{"name":108,"class":109},"ProCell Surgical Inc.","UNKNOWN","100481202","analysis-of-red-blood-cell-integrity-and-efficiency-of-recovery-using-a-novel-surgical-sponge-blood-recovery-device-procell-100481202",false,"NCT05545930","Analysis of Red Blood Cell Integrity and Efficiency of Recovery Using a Novel Surgical Sponge-Blood Recovery Device (ProCell)","Inclusion Criteria:\n\n* Undergoing heart or lung transplant, redo sternotomy, aortic surgery, and\u002For multi-valve repairs\u002Freplacements; and\n* At University Hospitals Cleveland Medical Center.\n\nExclusion Criteria:\n\n* Patients with known bleeding disorders, including disseminated intravascular coagulation (DIC), prothrombin deficiency, factor V deficiency, factor VII deficiency, factor X deficiency, factor XI deficiency (hemophilia C), Glanzmann disease, hemophilia A, hemophilia B, idiopathic thrombocytopenic purpura (ITP), and Von Willebrand disease (types I, II, and III);\n* Patients undergoing emergent or emergent salvage surgery; and\n* Patients actively participating in another clinical trial which could affect outcomes.","ALL","18 Years","89 Years",{"count":120,"type":121},20,"ESTIMATED","INTERVENTIONAL",[124],"NA","The purpose of this research study is to compare two methods of recovering blood from surgical sponges used during heart and lung surgeries. The two methods are: 1) manually wringing sponges by hand, and 2) automated wringing sponges by an FDA approved suction device. Both methods are already in use in heart and lung surgeries at University Hospitals at the discretion of the surgeon.",[127],"Blood Recovery",[129,130,131,132],"Open Heart Surgery","Heart Transplant","Lung Transplant","ProCell","2026-09-23",{"date":135,"type":136},"2026-09-25","ACTUAL",{"date":138,"type":136},"2022-09-20",{"date":140,"type":121},"2027-02-01",{"name":5,"class":6},1]