[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02182180":3,"trial-entities:NCT02182180":145,"trial-summary:NCT02182180":148},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":17,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":27,"secondary_outcomes":32,"sex":33,"minimum_age":34,"maximum_age":17,"healthy_volunteers":35,"eligibility_criteria":36,"std_ages":44,"locations":47,"central_contacts":105,"overall_officials":106,"references":120,"see_also_links":131},"NCT02182180","SC2I SUR902506","SC2i Tissue and Data Repository Protocol","Surgical Critical Care InitiativeTissue and Data Acquisition Protocol","RECRUITING","2027-08","2025-08","2025-09-04","2014-09-09","Henry M. Jackson Foundation for the Advancement of Military Medicine","OTHER",false,"The purpose of this study is to collect samples of blood, urine, cerebrospinal fluid (CSF, the fluid that surrounds the brain and spinal cord), wound tissue and\u002For wound fluids, and other body fluids and tissues from people who have been seriously injured or ill. The samples will be used to develop and assess tests and\u002For tools that doctors can use to decide the best treatment plan for seriously injured or ill military personnel and for civilians. Additonal protocols to use the samples will be submitted as separate protocols.",null,[19],"Critical Illness",[],"OBSERVATIONAL",[],{"count":24,"type":25},5000,"ESTIMATED",[],[28],{"measure":29,"description":30,"timeFrame":31},"Collecting, processing and archiving human tissue","Samples of blood, urine, cerebrospinal fluid, wound tissue and\u002For wound fluids, and other body fluids and tissues from people who have been seriously injured or ill will be collected. The samples will be used to develop and assess tests and\u002For tools that doctors can use to decide the best treatment plan for seriously injured or ill military personnel and for civilians. Additional research on the samples will be under separate protocols. This is a collection protocol.","Samples will be stored indefinitely in repository",[],"ALL","18 Years",true,{"inclusion":37,"exclusion":41,"raw_text":43},[38,39,40],"Patients with injury or illness requiring surgical care or treatment in a critical care or emergency setting who are being cared for at SC2I sites (Grady Memorial Hospital, Emory Univeristy Hospital, and Duke University Health Systems)","Healthy volunteer control subjects to include individuals without any known injury or end-stage organ disease and patients who have recovered from prior injury.","Ability to understand the purposes and risks of the study and willingly give written informed consent, or in the case of incapacitated patients, a willing surrogate able to give written informed consent.",[42],"Any condition that, in the opinion of the attending physician, would place the patient or volunteer subject at undue risk by participating. Specific conditions include but are not limited to anemia prohibitive of phlebotomy, coagulopathy, or technical considerations that would prevent acquisition of sufficient tissue or fluid for clinical use. Acquisition of samples from patients requiring active transfusion or with transfusion-associated coagulopathy will be considered as appropriate study candidates at the discretion of the attending physician.","Inclusion Criteria:\n\n* Patients with injury or illness requiring surgical care or treatment in a critical care or emergency setting who are being cared for at SC2I sites (Grady Memorial Hospital, Emory Univeristy Hospital, and Duke University Health Systems)\n* Healthy volunteer control subjects to include individuals without any known injury or end-stage organ disease and patients who have recovered from prior injury.\n* Ability to understand the purposes and risks of the study and willingly give written informed consent, or in the case of incapacitated patients, a willing surrogate able to give written informed consent.\n\nExclusion Criteria:\n\n* Any condition that, in the opinion of the attending physician, would place the patient or volunteer subject at undue risk by participating. Specific conditions include but are not limited to anemia prohibitive of phlebotomy, coagulopathy, or technical considerations that would prevent acquisition of sufficient tissue or fluid for clinical use. Acquisition of samples from patients requiring active transfusion or with transfusion-associated coagulopathy will be considered as appropriate study candidates at the discretion of the attending physician.",[45,46],"ADULT","OLDER_ADULT",[48,65,76,90],{"facility":49,"status":8,"city":50,"state":51,"zip":52,"country":53,"contacts":54,"geoPoint":62},"Grady Health Systems","Atlanta","Georgia","30303","United States",[55,60],{"name":56,"role":57,"phone":58,"email":59},"Christopher J. Dente, MD","CONTACT","404-251-8915","cdente@emory.edu",{"name":56,"role":61},"PRINCIPAL_INVESTIGATOR",{"lat":63,"lon":64},33.749,-84.38798,{"facility":66,"status":8,"city":50,"state":51,"zip":67,"country":53,"contacts":68,"geoPoint":75},"Emory University","30322",[69,73],{"name":70,"role":57,"phone":71,"email":72},"Timothy Buchman, MD, PhD","404-712-2602","tbuchma@emory.edu",{"name":74,"role":61},"Timothy G Buchman, Ph.D., MD",{"lat":63,"lon":64},{"facility":77,"status":8,"city":78,"state":79,"zip":80,"country":53,"contacts":81,"geoPoint":87},"Walter Reed National Military Medical Center","Bethesda","Maryland","20889",[82,86],{"name":83,"role":57,"phone":84,"email":85},"Benjamin K Potter, MD, FACS","301-400-2723","benjamin.k.potter.mil@mail.mil",{"name":83,"role":61},{"lat":88,"lon":89},38.98067,-77.10026,{"facility":91,"status":8,"city":92,"state":93,"zip":94,"country":53,"contacts":95,"geoPoint":102},"Duke University Health Systems","Durham","North Carolina","27710",[96,100],{"name":97,"role":57,"phone":98,"email":99},"Allan Kirk, MD, PhD","919-681-4853","allan.kirk@dm.duke.edu",{"name":101,"role":61},"Allan Krik, MD, Ph.D",{"lat":103,"lon":104},35.99403,-78.89862,[],[107,111,114,116,118],{"name":108,"affiliation":109,"role":110},"CAPT Eric Elster, MD, US Navy","Uniformed Services University of the Health Sciences","STUDY_DIRECTOR",{"name":112,"affiliation":113,"role":61},"Allan M. Kirk, MD, PhD","Duke University",{"name":115,"affiliation":66,"role":61},"Timothy G Buchman, Ph.D, MD",{"name":56,"affiliation":117,"role":61},"Grady Hospital",{"name":83,"affiliation":119,"role":61},"Uniformed Services University - Walter Reed Surgery",[121,125,128],{"pmid":122,"type":123,"citation":124},"40223169","DERIVED","Haines KL, Li R, Grey S, Kim HE, Gann E, Almond C, Rouse M, Joshi M, Schobel S, Agarwal S, Kirk A, Elster E, Fernandez-Moure JS. Exploratory cluster analysis of IL2Ra and associated biomarkers and complications after blunt chest trauma. J Trauma Acute Care Surg. 2025 Jun 1;98(6):899-906. doi: 10.1097\u002FTA.0000000000004568. Epub 2025 Apr 14.",{"pmid":126,"type":123,"citation":127},"39471078","Rindler RS, Robertson H, De Yampert L, Khatri V, Texakalidis P, Eshraghi S, Grey S, Schobel S, Elster EA, Boulis N, Grossberg JA. Predicting Vasospasm and Early Mortality in Severe Traumatic Brain Injury: A Model Using Serum Cytokines, Neuronal Proteins, and Clinical Data. Neurosurgery. 2025 May 1;96(5):1133-1145. doi: 10.1227\u002Fneu.0000000000003224. Epub 2024 Oct 11.",{"pmid":129,"type":123,"citation":130},"33790901","Gerardo CJ, Silvius E, Schobel S, Eppensteiner JC, McGowan LM, Elster EA, Kirk AD, Limkakeng AT. Association of a Network of Immunologic Response and Clinical Features With the Functional Recovery From Crotalinae Snakebite Envenoming. Front Immunol. 2021 Mar 15;12:628113. doi: 10.3389\u002Ffimmu.2021.628113. eCollection 2021.",[132,135,137,139,142],{"label":133,"url":134},"Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.","http:\u002F\u002Fwww.hjf.org",{"label":109,"url":136},"http:\u002F\u002Fwww.usuhs.edu",{"label":49,"url":138},"http:\u002F\u002Fwww.gradyhealth.org\u002F",{"label":140,"url":141},"Duke University Medical Center","http:\u002F\u002Fwww.dukemedicine.org\u002F",{"label":143,"url":144},"Emory Healthcare","http:\u002F\u002Fwww.emoryhealthcare.org",{"nct_id":4,"conditions":146,"biomarkers":147},[19],[],{"nct_id":4,"found":35,"summary":149,"prompt_version":159},{"design":150,"status":151,"heading":152,"summary":153,"follow_up":154,"word_count":155,"commitments":156,"compensation":157,"drugs_mentioned":158},"This is an observational study planning to enroll 5000 participants. It involves collecting samples from people with critical illness and healthy volunteers.","completed","SC2i Tissue and Data Repository for Critical Illness","This study is collecting samples like blood, urine, and wound tissue from people who are seriously injured or ill, as well as from healthy volunteers. The goal is to create a collection of these samples to help doctors develop better tests and tools for treating critically ill military personnel and civilians. This study is observational, meaning researchers are collecting information without giving any specific treatments. Success for this study means building a valuable collection of samples that can be used for future research. The current recruitment status is unclear.","Samples will be stored indefinitely in the repository.",89,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]