[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100487976":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":32,"locations":38,"responsibleParty":70,"collaborators":72,"id":78,"slug":25,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":25,"enrollmentInfo":87,"targetDuration":25,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":40,"whyStopped":25,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"Fundacion Clinica Valle del Lili","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Whole Blood","EXPERIMENTAL","Leukoreduced whole blood with a platelet-sparing filter. Participants will be transfused with 3 whole blood units. If the participant requires, an additional transfusion pack composite by 3 whole blood units will be administered.",[13],"Biological: Transfusion of blood products",{"label":15,"type":16,"description":17,"interventionNames":18},"Blood Components Therapy","ACTIVE_COMPARATOR","1:1:1 ratio of red blood cells unit, plasma unit, and platelets unit. Participants will be transfused with 3 red blood cell units, 3 fresh frozen plasma units, and 3 platelets units. A second intervention with the same ratio can be transfused to participants if they require it.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Transfusion of blood products","The intervention will be either a) administration of 6 units of whole blood or b) administration of blood component therapy in the proportion of 6:6:6 units of red blood cells, plasma, and platelets.",[15,9],null,[27,30],{"name":28,"affiliation":5,"role":29},"Alberto F Garcia, MD MSc","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":5,"role":29},"Carlos A Ordoñez, MD",[33],{"name":28,"role":34,"phone":35,"phoneExt":36,"email":37},"CONTACT","+576023319090","4299","alberto.garcia@fvl.org.co",[39],{"facility":5,"status":40,"city":41,"state":42,"zip":25,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Cali","Valle del Cauca Department","Colombia","CO",{"type":46,"coordinates":47},"Point",[48,49],-76.5199,3.43054,{"lat":49,"lon":48},[52,57,58,59,62,64,66,68],{"name":53,"role":34,"phone":54,"phoneExt":55,"email":56},"Sergio I Prada, MPA PhD","+57 (2) 3319090","4022","sergio.prada@fvl.org.co",{"name":28,"role":29,"phone":25,"phoneExt":25,"email":25},{"name":31,"role":29,"phone":25,"phoneExt":25,"email":25},{"name":60,"role":61,"phone":25,"phoneExt":25,"email":25},"Carmenza Macia, MD","SUB_INVESTIGATOR",{"name":63,"role":61,"phone":25,"phoneExt":25,"email":25},"Gustavo Ospina, MD PhD",{"name":65,"role":61,"phone":25,"phoneExt":25,"email":25},"Yaset Caicedo, MD",{"name":67,"role":61,"phone":25,"phoneExt":25,"email":25},"Andres Gempeler, MD MSc",{"name":69,"role":61,"phone":25,"phoneExt":25,"email":25},"Liliana Vallecilla, MD",{"type":71,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[73,75],{"name":74,"class":6},"University of Pittsburgh",{"name":76,"class":77},"Hospital Universitario del Valle Evaristo Garcia","UNKNOWN","100487976",false,"NCT05634109","Whole Blood in Trauma Patients With Hemorrhagic Shock","Whole Blood vs. Blood Components Therapy in the Hemostatic Resuscitation of Severe Trauma Patients: An Open-label, Randomized, Controlled Clinical Trial","WEBSTER","Inclusion Criteria:\n\n* Adult patients (\\> 18 years)\n* Activating institutional trauma code for trauma patients with hemorrhagic shock.\n* Candidate for massive transfusion (Patient with an Assessment Blood Consumption (ABC) Score ≥ 2 or at the discretion of the treating physician)\n* Concurrent availability of whole blood or blood component therapy\n\nExclusion Criteria:\n\n* More than 4 hours from trauma to hospital admission\n* More than 2 hours from hospital admission to randomization\n* Transfusion of more than one packed red blood cell unit prior to randomization.\n* Patients who have undergone surgery (laparotomy, thoracotomy, or sternotomy) before hospital admission.\n* In-extremis patients with devastating injuries (expected to die within 60 minutes).\n* Blood group other than to O or A and positive Rh factor\n* Severe traumatic brain injury in which neurosurgical intervention is futile (partial decapitation, massive intracranial hemorrhage, or transcranial gunshot wounds).\n* Burns over 20% of the total body surface area.\n* Suspected airway burn.\n* Cardiopulmonary resuscitation (CPR) before arrival at the ED.\n* CPR for more than 5 minutes before randomization.\n* Do not resuscitate order.\n* Incarcerated\u002Fprisoners.\n* Known pregnancy in the ED.\n* Patient or legal representative who refuse to participate in clinical research studies.","ALL","18 Years",{"count":88,"type":89},220,"ESTIMATED","INTERVENTIONAL",[92],"PHASE3","This study aims to evaluate among trauma patients with hemorrhagic shock the clinical impact of hemostatic resuscitation between whole blood vs. blood components therapy in the following outcomes in a hierarchical analysis: mortality at 28 days and evolution of organ dysfunction.",[95,96,97],"Trauma","Trauma Injury","Trauma, Multiple",[99,100,101,102,103,104],"whole blood","Blood Transfusion","Blood Component Transfusion","Hemorrhage","Advanced Trauma Life Support Care","Hemostatic resuscitation","2025-02-24",{"date":107,"type":108},"2025-02-27","ACTUAL",{"date":110,"type":108},"2023-01-14",{"date":112,"type":89},"2026-03",{"name":5,"class":6},1]