[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100487976":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":32,"locations":38,"responsibleParty":69,"collaborators":71,"id":77,"slug":25,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":25,"enrollmentInfo":86,"targetDuration":25,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":40,"whyStopped":25,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"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,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Cali","Valle del Cauca Department","Colombia",{"type":45,"coordinates":46},"Point",[47,48],-76.5199,3.43054,{"lat":48,"lon":47},[51,56,57,58,61,63,65,67],{"name":52,"role":34,"phone":53,"phoneExt":54,"email":55},"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":59,"role":60,"phone":25,"phoneExt":25,"email":25},"Carmenza Macia, MD","SUB_INVESTIGATOR",{"name":62,"role":60,"phone":25,"phoneExt":25,"email":25},"Gustavo Ospina, MD PhD",{"name":64,"role":60,"phone":25,"phoneExt":25,"email":25},"Yaset Caicedo, MD",{"name":66,"role":60,"phone":25,"phoneExt":25,"email":25},"Andres Gempeler, MD MSc",{"name":68,"role":60,"phone":25,"phoneExt":25,"email":25},"Liliana Vallecilla, MD",{"type":70,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[72,74],{"name":73,"class":6},"University of Pittsburgh",{"name":75,"class":76},"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":87,"type":88},220,"ESTIMATED","INTERVENTIONAL",[91],"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.",[94,95,96],"Trauma","Trauma Injury","Trauma, Multiple",[98,99,100,101,102,103],"whole blood","Blood Transfusion","Blood Component Transfusion","Hemorrhage","Advanced Trauma Life Support Care","Hemostatic resuscitation","2025-02-24",{"date":106,"type":107},"2025-02-27","ACTUAL",{"date":109,"type":107},"2023-01-14",{"date":111,"type":88},"2026-03",{"name":5,"class":6},1]