[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hemorrhagic-shock\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hemorrhagic-shock":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,49,82,109,139],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100609715","cryo-first-effectiveness-of-intercept-fibrinogen-complex-ifc-for-trauma-associated-hemorrhage-100609715",false,"NCT07218185","Cryo-FIRST: Effectiveness of INTERCEPT Fibrinogen Complex (IFC) for Trauma-Associated Hemorrhage","Cryo-FIRST: Cryoprecipitate For Immediate Resuscitation in Severe Trauma: Effectiveness of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex, IFC) for Treatment of Trauma Associated Hemorrhage","CRYO-FIRST","Inclusion Criteria:\n\n* Traumatic injury\n* Age ≥18 years or estimated weight ≥50 kg, if age unknown\n* Presenting to a participating trauma center ≤1 hour from estimated time of injury\n* Functional hypofibrinogenemia upon arrival to the trauma center as measured by point-of-care testing (Quantra®) with FCS \\\u003C1.6 hPa\n* Hemorrhagic shock, defined as:\n\n  1. Initiation of transfusion of any uncrossmatched blood product;\n  2. Evidence of active hemorrhage as judged by the attending trauma surgeon; and\n  3. Initiation of the participating trauma center's massive transfusion protocol (MTP)\n* IFC administration is clinically indicated per the treating physician\n* IFC is available at the time of enrollment\n\nExclusion Criteria:\n\n* Suspected isolated severe brain or spinal cord injury\n* Isolated drowning or hanging\n* Burns \\>20% total body surface area (TBSA)\n* Known pregnancy\n* Admitted from a correctional facility\n* Known do not resuscitate (DNR) order\n* Traumatic arrest \\>5 minutes, defined as continuous CPR \\>5 minutes at any time point prior to enrollment in the study\n* Isolated fall from standing\n* Emergency Department (ED) thoracotomy","ALL","18 Years",{"count":20,"type":21},320,"ESTIMATED","OBSERVATIONAL","The objective of this multicenter, single-arm, observational study is to determine the feasibility and effectiveness of early administration of FDA-approved, pre-thawed Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex, IFC) in trauma patients with hemorrhagic shock (HS) and functional hypofibrinogenemia. This study will determine whether rapid point-of-care testing for functional hypofibrinogenemia and availability of a shelf-stable fibrinogen complex (IFC) results in shorter time to administration of fibrinogen replacement and correction of functional hypofibrinogenemia, as compared with historical controls and published literature using conventional cryoprecipitate-AHF (CRYO-AHF).\n\nThis study aims to:\n\n* Demonstrate the feasibility and response to early administration of pre-thawed IFC when ordered during initial resuscitation of severely injured patients with HS and functional hypofibrinogenemia.\n* Assess the effectiveness of early administration of pre-thawed IFC on correction of functional hypofibrinogenemia and on proximate process measures of resuscitation, including time to hemostasis, time to completion of resuscitation, and total volume of resuscitation.\n* Assess clinical outcomes in severely injured patients with HS and functional hypofibrinogenemia receiving early administration of pre-thawed IFC.",[25,26,27,28],"Hypofibrinogenemia","Hemorrhage","Trauma Associated Hemorrhage","Hemorrhagic Shock",[30,26,31,32,33,34,28,35],"Fibrinogen","Trauma","Resuscitation","INTERCEPT Fibrinogen Complex","Pathogen Reduced Cryoprecipitated Fibrinogen Complex","Quantra","NOT_YET_RECRUITING","2026-06-16",{"date":39,"type":40},"2026-06-17","ACTUAL",{"date":42,"type":21},"2026-07",{"date":44,"type":21},"2028-08",{"name":46,"class":47},"Cerus Corporation","INDUSTRY",4,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100521496","phase-3-massive-transfusion-in-children-2-a-trial-examining-life-threatening-hemorrhage-in-children-100521496","NCT06070350","Massive Transfusion in Children-2: A Trial Examining Life Threatening Hemorrhage in Children","Massive Transfusion in Children: a Platform RCT of Whole Blood Compared to Component Therapy and Tranexamic Acid to Placebo in Life-threatening Traumatic Bleeding","MATIC-2","General Inclusion Criteria:\n\n1. Children, defined as less than estimated18 years of age with traumatic injury\n2. MTP activation for confirmed or suspected active life-threatening traumatic bleeding\n\nAND\n\nConfirmed or suspected active life-threatening traumatic bleeding with at least 2 of 3 of the following criteria:\n\n1. Hypotension for age (\\\u003C 5% tile)\n2. Tachycardia for age (\\>95th % tile)\n3. Traumatic injury with exam findings consistent with severe bleeding (e.g., penetrating injury, hemothorax, distended abdomen with bruising, amputation of limb).\n\nGeneral Exclusion Criteria:\n\n1. Patient with devastating traumatic brain injury not expected to survive due to magnitude of injury (example: Transhemispheric gunshot wound with signs of herniation, GCS score of 3 with fixed and dilated pupils)\n2. MTP activated but no blood products given\n3. Patients who required an ED thoracotomy or received more than 5 consecutive minutes of cardiopulmonary resuscitation (prior to receiving randomized blood products)\n4. Patients who are known or suspected to be pregnant on clinical examination\n5. Known prisoners as defined in protocol\n6. Known ward of the state\n7. Isolated hanging, drowning or burns\n8. Previous enrollment in MATIC-2\n9. Prior study opt-out with bracelet\n\nExclusion Criteria for the TXA\u002FPlacebo Domain\n\n1. Prehospital or pre-enrollment use of TXA\n2. Greater than 3 hours since time of injury\n3. History of seizure after the injury event\n4. Known allergy or hypersensitivity reaction to TXA","17 Years",{"count":59,"type":21},1000,"INTERVENTIONAL",[62],"PHASE3","The MATIC-2 is a multicenter clinical trial enrolling children who are less than 18 years of age with hemorrhagic shock potentially needing significant blood transfusion.\n\nThe primary objective of the clinical trial is to determine the effectiveness of Low Titer Group O Whole Blood (LTOWB) compared to component therapy (CT), and Tranexamic Acid (TXA) compared to placebo in decreasing 24-hour all-cause mortality in children with traumatic life threatening hemorrhage.",[28,65],"Trauma Injury",[67,68,69],"Children","Pediatrics","Transfusion","RECRUITING","2026-05-07",{"date":73,"type":40},"2026-05-11",{"date":75,"type":40},"2024-11-01",{"date":77,"type":21},"2028-10-01",{"name":79,"class":80},"Philip Spinella","OTHER",23,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":90,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":60,"phases":93,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":108},"100276581","revive-reducing-exsanguination-via-in-vivo-expandable-foam-100276581","NCT02880163","REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam","Reducing Exsanguination Via In-Vivo Expandable Foam","REVIVE","Inclusion Criteria:\n\n1. Estimated age of 15 years or older (or subject weight estimated at greater than 50 kg if age is unknown)\n2. Emergent, exsanguinating hemorrhage, from abdominal source as defined by:\n\n   * Class III or IV hemorrhagic shock or\n   * Assessment of Blood Consumption (ABC) score ≥ 2\n3. Confirmation of abdominal hemorrhage by:\n\n   * Direct visualization or\n   * Positive Focused Assessment with Sonography in Trauma (FAST) or\n   * Diagnostic Peritoneal Aspiration (DPA)\n4. No other known, uncontrolled active sources of hemorrhage\n5. Subject is intubated and sedated per local guidelines\n6. Decision to administer foam is made within 30 minutes of admission to the emergency department.\n7. Decision made to proceed to emergent laparotomy made within 30 minutes of admission to the emergency department.\n8. Definitive surgical care is expected to occur within three hours of foam deployment\n9. Subject must also be receiving concurrent transfusion of fluids or blood products.\n\n   Exclusion Criteria:\n10. Known or suspected major diaphragm injury\n11. Known or suspected untreated pneumothorax\n12. Known or suspected untreated hemothorax\n13. Known or suspected blunt or penetrating cardiac or thoracic aortic trauma\n14. Traumatic brain injury resulting in decapitation, visible brain matter or considered non- survivable based on initial physical exam\n15. Received greater than five consecutive minutes of cardiopulmonary resuscitation in the pre-emergency department setting\n16. Patients with Pulseless Electrical Activity\n17. Known allergy to isocyanate\n18. Known or suspected pregnancy\n19. History of prior abdominal surgery or evidence of abdominal surgery (scars)\n20. Disrupted abdominal wall that, in the opinion of the investigator would preclude ResQFoam from being adequately contained within the abdominal cavity\n21. Subject in whom the abdominal aortic junctional tourniquet (AAJT) or Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) techniques have been used\n22. Known Prisoners\n23. Subjects with burns \\> 20% of total body surface area\n24. Subject\u002Flegally authorized representative\u002Fsubject family member purposefully opted out of participation in the study\n25. Known Do Not Resuscitate order (DNR) or Physician Orders for Life Sustaining Treatment (POLST)\n26. Known enrollment in another randomized, interventional study","15 Years",{"count":92,"type":21},40,[94],"NA","The purpose of this study is to demonstrate safety, effectiveness and benefit-risk profile of ResQFoam for the inhospital treatment of exsanguinating, intraabdominal haemorrhage due to trauma in patients where emergent laparotomy is required.",[28,31,97,98],"Exsanguinating Hemorrhage","Shock; Traumatic","2025-11-07",{"date":101,"type":40},"2025-11-10",{"date":103,"type":40},"2025-08-07",{"date":105,"type":21},"2026-12-31",{"name":107,"class":47},"Arsenal Medical, Inc.",2,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":60,"phases":119,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":138},"100602862","phase-3-optimization-strategies-for-blood-transfusion-protocols-in-the-emergency-treatment-of-hemorrhagic-shock-100602862","NCT07129031","Optimization Strategies for Blood Transfusion Protocols in the Emergency Treatment of Hemorrhagic Shock","Inclusion Criteria:\n\n* Patients with hemorrhagic shock due to trauma or upper gastrointestinal bleeding who meet emergency transfusion criteria (hemoglobin \\\u003C 7 g\u002FdL or active bleeding).\n\nAge 10-90 years. Time from onset to hospital admission \\\u003C 24 hours.\n\nExclusion Criteria:\n\n* Severe underlying diseases (end-stage organ failure or active malignancy). Known coagulopathy or history of severe transfusion reactions. Refusal to participate or inability to complete follow-up.","10 Years","90 Years",{"count":118,"type":21},180,[62],"This single-center, prospective, randomized controlled trial was approved by the institutional ethics committee and overseen by an independent data and safety monitoring board. It enrolled patients with hemorrhagic shock caused by trauma or major gastrointestinal bleeding. Using a random-number-table method, participants were allocated to three groups: (1) Control group: standard massive transfusion protocol (MTP) with transfusing type-specific blood components in a 1:1:1 ratio. (2) Type-specific whole-blood group: following emergency ABO typing and cross-matching, type-specific whole blood was transfused. (3) Low-titer group O whole-blood group: in the emergency phase, 4 units of low-titer group O whole blood (anti-A\u002FB IgM titer \\\u003C 1:64) were infused; after definitive ABO typing, patients were switched to type-specific whole blood. Clinical data were automatically extracted from the electronic medical record system. Primary endpoints were efficacy (28-day survival), timeliness (transfusion waiting time and time to achieve target mean arterial pressure), cost-effectiveness (total blood consumption and transfusion-related expenses), and safety (transfusion-associated adverse events including TRALI and hemolytic reactions).Statistical analyses included Kaplan-Meier survival curves and Cox proportional-hazards regression, adjusting for confounders such as age and disease severity scores. The advantages and disadvantages of each transfusion strategy were evaluated, and an optimized strategy for emergency blood transfusion in hemorrhagic shock was developed. This strategy was peer-reviewed and refined, culminating in a standardized, multidisciplinary, emergency-transfusion protocol.",[26,28,122],"Upper Gastrointestinal Bleeding (UGIB)",[124,125,126,127,128],"Hemorrhagic shock","transfusion","low-titer O-group whole blood","group of 1:1:1 component","group of ABO- and Rh-compatible whole blood","2025-08-18",{"date":131,"type":40},"2025-08-19",{"date":133,"type":21},"2025-09-01",{"date":135,"type":21},"2027-12-31",{"name":137,"class":80},"Xijing Hospital",1,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":148,"conditions":149,"keywords":155,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":138},"100567596","evaluation-of-endothelial-glycocalyx-in-the-surgical-resuscitation-of-major-burn-patients-100567596","NCT06670248","Evaluation of Endothelial Glycocalyx in the Surgical Resuscitation of Major Burn Patients","GlycoBURN Study: Determination of Endothelial Glycocalyx Status in the Surgical Resuscitation of Severe Burn Patients","GlycoBURN","Inclusion Criteria:\n\n* Patients over 18 years old with burned TBSA greater than or equal to 20%.\n* Patients who will undergo debridement of at least 20% of the burned TBSA (including the debrided area and the donor site).\n\nExclusion Criteria:\n\n* Under 18 years old.\n* Pregnant women.\n* Patient refusal.\n* Polytraumatized patients.\n* Electrical or chemical burns.\n* Patients with any of the following pre-burn conditions: complicated heart disease\\*, renal disease on hemodialysis\u002Fhemofiltration or with Glomerular Filtration Rate (GFR) \\\u003C 30 ml\u002Fmin\u002F1.73m², and liver cirrhosis (Child A, B, and C).\n\n(\\* Definition of complicated heart disease: decompensated heart failure (NYHA class IV), Left Ventricular Ejection Fractio \\\u003C 40%, or severe valvular disease).\n\n* Patients with a history of chronic inflammatory diseases (autoimmune disease).\n* Patients on chronic treatment with corticosteroids or immunosuppressants.\n* Patients requiring reintervention for debridement surgery who have already been included in the study during their first surgery.",{"count":92,"type":21},"The purpose of this observational study is to examine whether Endotheliopathy of Trauma (EoT) is present in severely burned patients and how it is affected by burn debridement surgery.\n\nThe main questions it aims to answer are:\n\n* Do severely burned patients present with EoT before undergoing burn debridement surgery?\n* Does the surgical intervention worsen EoT, leading to increased postoperative syndecan 1 (sdc 1) levels compared to preoperative levels?\n\nParticipants will:\n\n* Undergo debridement surgery where the total area of debrided and donor sites covers 20% or more of the Total Body Surface Area (TBSA).\n* Have their sdc 1 levels measured before and after surgery.\n* Have perioperative factors analyzed to assess their impact on endothelial damage and glycocalyx functionality.\n\nThis study aims to provide insight into how surgical resuscitation affects the endothelial glycocalyx in severely burned patients.",[150,151,152,153,28,154],"Syndecan 1","Severe Burn","Endotheliopathy of Trauma","Endothelial Glycocalyx","Postoperative Complications",[150,156,157,158,159],"Endotheliopathy","Glycocalyx","Proteoglycan","Severe burn","2024-10-30",{"date":75,"type":40},{"date":163,"type":40},"2024-03-05",{"date":165,"type":21},"2026-09",{"name":167,"class":80},"Hospital Universitari Vall d'Hebron Research Institute"]