[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100362441":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":44,"locations":53,"responsibleParty":77,"collaborators":81,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":27,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":27,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":55,"whyStopped":27,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Case Western Reserve University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Blood transfusion with SNO agent","ACTIVE_COMPARATOR","Autologous blood transfusion packed red blood cells (RBCs) while inhaling S-nitrosylating agent (SNO)\n\nA single intra venous blood transfusion of one unit of packed Red Blood Cells (RBCs) will be given over the standard transfusion flow rate of 5 ml\u002Fmin under the direction of a physician or a licensed medical professional.\n\nInhalation of SNO agent, 20-40 parts per million will occur during the transfusion.",[13,14],"Drug: SNO","Drug: Red Blood Cell",{"label":16,"type":17,"description":18,"interventionNames":19},"Normal Saline with SNO agent","PLACEBO_COMPARATOR","Normal Saline Transfusion while inhaling S-nitrosylating agent (SNO)\n\nA single intra venous infusion of one unit of normal saline, will be given over the standard transfusion flow rate of 5 ml\u002Fmin under the direction of a physician or a licensed medical professional.\n\nInhalation of the SNO agent at 40 parts per million, will occur during the transfusion.",[13,20],"Drug: Normal Saline",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","SNO","S-nitrosylating agent (SNO) Inhalation",[9,16],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Normal Saline","Normal Saline transfusion",[16],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Red Blood Cell","Blood transfusion (RBCs)",[9],[37,40],{"name":38,"affiliation":5,"role":39},"James D. Reynolds, PhD","PRINCIPAL_INVESTIGATOR",{"name":41,"affiliation":42,"role":43},"Mada Helou, MD","University Hospitals Cleveland Medical Center","STUDY_DIRECTOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":27,"email":49},"James D Reynolds, PhD","CONTACT","216-334-9277","jxr343@case.edu",{"name":51,"role":47,"phone":48,"phoneExt":27,"email":52},"Sindhuja Senigarapu, MD","Sindhuja.Senigarapu@uhhospitals.org",[54],{"facility":42,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"RECRUITING","Cleveland","Ohio","44106","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-81.69541,41.4995,{"lat":65,"lon":64},[68,69,71,72,75],{"name":51,"role":47,"phone":48,"phoneExt":27,"email":52},{"name":46,"role":47,"phone":70,"phoneExt":27,"email":49},"(216) 368-5727",{"name":41,"role":39,"phone":27,"phoneExt":27,"email":27},{"name":73,"role":74,"phone":27,"phoneExt":27,"email":27},"Basanta Mohapatra, MD","SUB_INVESTIGATOR",{"name":76,"role":74,"phone":27,"phoneExt":27,"email":27},"Reid Rubsamen, MD",{"type":78,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"SPONSOR_INVESTIGATOR","James Reynolds","Professor of Anesthesiology and Perioperative Medicine and a member of the Case Institute for Transformative Molecular Medicine",[82,83],{"name":5,"class":6},{"name":84,"class":85},"National Heart, Lung, and Blood Institute (NHLBI)","NIH","100362441","phase-1-s-nitrosylation-sno-therapy-during-autologous-blood-transfusion-100362441",false,"NCT03999229","S-Nitrosylation (SNO) Therapy During Autologous Blood Transfusion","Phase 1 Study of S-Nitrosylation Therapy to Improve Tissue Oxygenation During Autologous Blood Transfusion in Healthy Volunteer","Eligibility Criteria\n\nRecruiting and studying of healthy human subjects with no pre-existing pathologic conditions from the local population. As a result the inclusion criteria is deliberately broad.\n\nInclusion Criteria\n\n1. Hemoglobin \\> 12 g\u002Fdl\n2. Healthy, non-pregnant adults with no pre-existing blood disorders or disease states that impact oxygen delivery.\n\n2a. Active blood and platelet donors will be sought as study participants since these individuals are familiar with the routines for blood withdrawal and re-infusion.\n\nExclusion Criteria\n\nThe exclusion criteria is derived from the American Red Cross(ARC) Standard Operating Procedure (SOP) for autologous donation AND the parameters set out in the investigational new drug application (IND).\n\n1. Individuals who are pregnant, breastfeeding, or are unwilling to avoid pregnancy during the study.\n2. Individuals with an anatomic anomaly that would increase the risks associated with placement of the vascular catheters.\n3. Individuals who report chronic diseases requiring medication of the heart, lungs, kidney, liver, etc or afflicted with any acute or chronic pathology that in the opinion of the screening physician makes them unsuitable for study.\n4. Individuals with a recent history of antibiotic therapy (check for underlying cause).\n5. Individuals unwilling to refrain from taking any phosphodiesterase 5 (PDE-5) inhibitor for at least 24 h prior to donation and\u002For autologous transfusion.\n6. Individuals taking a vitamin K antagonist (warfarin) or other anticoagulant (e.g. heparin, clopidogrel, enoxaparin or dalteparin).\n7. Individuals taking allopurinol, beta-adrenergic blockers, tricyclic antidepressants, meperidine (or related central nervous system (CNS) agents), or nitrates.\n8. Individuals on long-term antihistamine therapy 8a. The study physician will determine on a case by case basis the suitability for inclusion of individuals who control seasonal or acute allergies with occasional antihistamine use.\n9. Individuals with blood pressure parameters outside the normal range, i.e., higher than 130 mm Hg systolic and\u002For higher than 90 mm Hg diastolic; mild hypertension is acceptable by the Red Cross for blood donation.\n10. Individuals with heart rates outside the range of 50 to 100 beats per minutes or with a pathologic irregularity.\n\n10a. Pulses lower than 50 may be acceptable if the study participant participates in endurance training. The study physician will be consulted for evaluation.\n\n11\\. Individuals with an inherited or acquired blood coagulation disorder, congenital methemoglobinemia, or a familial hemoglobinopathy that impacts oxygen delivery (e.g. sickle cell).\n\n12\\. Individuals with any illness that may increase the risks associated with the study.\n\n13\\. Individuals who previously received blood products to treat an acute condition will be evaluated on a case by case basis.\n\n14\\. Individuals who report an acute or chronic disease state that may impact oxygen delivery.\n\n15\\. Individuals with evidence of diminished lung capacity.\n\n16\\. Individuals who might have difficulty with the placement of a face mask (e.g. claustrophobia, uncontrolled asthma, severe allergies, sensitive skin) and\u002For the inhalation of a product for approximately 2-3 hours.",true,"ALL","18 Years","35 Years",{"count":98,"type":99},35,"ESTIMATED","INTERVENTIONAL",[102],"PHASE1","The Purpose of the study is to test the hypothesis that administration of an S-nitrosylating (SNO) agent can improve tissue oxygenation during transfusion of packed red blood cells (RBCs).",[105],"Transfusion Related Complication",[107,108,109,110],"S-Nitrosylation","Tissue Oxygenation","Anemia-induced tissue hypoxia","Red blood cell Transfusion","2025-11-25",{"date":113,"type":114},"2025-12-02","ACTUAL",{"date":116,"type":114},"2019-07-25",{"date":118,"type":99},"2028-02-29",{"name":79,"class":6},1]