[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cerus Corporation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":111},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,76],{"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":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":4},"100604658","phase-2-challenge-transfusion-of-intercept-pathogen-reduced-red-blood-cells-rbcs-in-subjects-with-or-without-pre-existing-antibodies-to-intercept-rbcs-100604658","NCT07152379","Challenge Transfusion of INTERCEPT Pathogen Reduced Red Blood Cells (RBCs) in Subjects With or Without Pre-existing Antibodies to INTERCEPT RBCs","An Open-label, Controlled Phase 2 Study Assessing a Challenge Transfusion of INTERCEPT Pathogen Reduced Red Blood Cells (RBCs) in Subjects With or Without Pre-existing Antibodies to INTERCEPT RBCs","Challenge","Inclusion Criteria:\n\n* Age ≥4 years in children who meet the requirement of US Code of Federal Regulation (CFR) Title 21, §50.53 as determined by the local Institutional Review Board (IRB).\n* Control subjects shall have no current or previously documented antibodies to INTERCEPT RBC.\n* Test subjects shall have current or previously documented natural or treatment-emergent antibodies to INTERCEPT RBCs.\n* History of prior transfusion with allogeneic blood products (INTERCEPT or non-INTERCEPT treated).\n* \\>120 days from the subjects most recent exposure to Study RBCs (pathogen reduced or non-pathogen reduced - if any) prior to the planned study transfusion.\n* Signed and dated informed consent form\n\nExclusion Criteria:\n\n* Foreseeable active blood loss due to trauma, surgery, or pathologic condition during the study period.\n* Exposure to another interventional drug or device in a clinical study within 28 days prior to enrollment or concurrently during the study.\n* Positive Direct Antiglobulin Test (≥2+) at the time of screening, prior to the first study transfusion.\n* Current or historical medical conditions judged by the Investigator to significantly increase the risk of morbidity\u002Fmortality due to hemolysis or the medical management of acute hemolysis.\n* Treatment with any medication known to affect RBC viability at the time of enrollment (e.g., ribavirin, sulfa drugs, chemotherapy medications, methylene blue, dapsone, levodopa, methyldopa, nitrofurantoin and its derivatives, phenazopyridine, quinidine, and hydantoins)\n* History of or development of a drug-associated RBC antibody not associated with INTERCEPT RBCs.\n* Congenital or acquired immunodeficiency judged by the Investigator to potentially impact the humoral immune response.\n* Immunosuppressive therapy within 1 month prior to enrollment or during the study period, including steroids and intravenous immunoglobulin.\n* Current or historical RBC alloantibodies that are judged by the Investigator to prevent selection of antigen-negative RBCs for transfusion.\n* History of immunoglobulin A (IgA) deficiency, severe allergic reaction to blood product(s), or clinical requirement to receive washed cellular products.\n* History of warm autoantibody with hemolysis.\n* Subjects who are pregnant, or biologically able to become pregnant and unwilling to remain on medically accepted contraception during this study.","4 Years",{"count":59,"type":21},10,"INTERVENTIONAL",[62],"PHASE2","This study aims to determine whether transfusion of INTERCEPT RBCs into patients with pre-existing antibodies to INTERCEPT RBCs will result in increased antibody titer indicative of a secondary immune response, and whether these immune responses would be associated with clinical adverse events, increased RBC clearance, and\u002For evidence of hemolysis. Because the recovery and survival of fresh allogeneic INTERCEPT RBCs in patients with a diverse group of diseases is poorly characterized, a Control group of subjects without a history or evidence of antibodies to INTERCEPT RBCs may be evaluated as a comparator (Control group subjects may or may not have previously been transfused with INTERCEPT RBCs).\n\nThe study will also compare and correlate results from anti-human globulin (AHG) crossmatch using INTERCEPT RBCs prepared for transfusion, with results from indirect antiglobulin testing (IAT) with S 303 treated reagent RBCs (i.e., INTERCEPT RBC screening assay, as used in previous studies) to assess the utility of the AHG crossmatch to define the compatibility of transfused INTERCEPT RBCs",[65],"Transfusion Reaction, Hemolytic",[67],"INTERCEPT, red blood cells, antibody","2026-06-04",{"date":70,"type":40},"2026-06-08",{"date":72,"type":21},"2026-06-01",{"date":74,"type":21},"2028-01-01",{"name":46,"class":47},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":60,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":101,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},"100594130","phase-2-a-recovery-and-lifespan-study-using-intercept-red-blood-cells-prepared-using-the-intercept-blood-system-for-rbcs-with-as-1-100594130","NCT07015437","A Recovery and Lifespan Study Using INTERCEPT Red Blood Cells Prepared Using the INTERCEPT Blood System for RBCs With AS-1","A Randomized, Controlled, Single-Blind, 2-Arm Parallel Study to Assess the Recovery and Lifespan of Radiolabeled Autologous INTERCEPT Red Blood Cells Prepared Using the INTERCEPT Blood System for RBCs With AS-1","Inclusion Criteria:\n\n* Age ≥18 years\n* Complete blood count (CBC) and serum chemistry values within normal limits or outside of normal reference range but determined by the Investigator, and consultation with the Sponsor, to be not clinically significant.\n* Meet FDA, AABB, or institutional guidelines for allogeneic WB donation, including viral marker testing, with the following exceptions:\n* Meeting allogeneic deferral criteria due to travel, tattoos\u002Fpiercings and male to male sexual contact would be acceptable, subject to the Investigator's discretion.\n* Subjects of childbearing potential must agree to use a medically acceptable method of contraception throughout the study.\n* Signed and dated informed consent form\n\nExclusion Criteria:\n\n* History of RBC autoantibodies, autoimmune hemolytic anemia, RBC allo-antibodies, or other autoimmune disease\n* History of congenital red cell disorders (including self-reported glucose 6 phosphate dehydrogenase (G- 6PD) deficiency, sickle cell trait and thalassemia minor trait)\n* Positive DAT or IAT at study entry\n* Immunosuppressive therapy (e.g., oral or IV prednisone) within the past 28 days\n* Treatment with any medication known to affect RBC viability\n* Pregnant or nursing females\n* Participation in another interventional clinical study currently or has received an investigational drug within the past 28 days\n* Less than three months from receiving an infusion of a radiolabeled blood component.\n* Reenrollment in the same treatment group for which the subject previously contributed recovery and survival data in this study.\n* Non study blood component donation throughout the study\n* Preexisting antibody specific to INTERCEPT RBCs\n* History of known hypersensitivity to chromium or technetium",true,{"count":85,"type":21},70,[62],"The objective of this trial is to assess the post-infusion viability of INTERCEPT RBCs by measuring the 24-hour post-infusion recovery and lifespan of autologous RBCs prepared with the INTERCEPT Blood System for RBC with AS-1 after 35 days post collection storage in comparison to untreated AS-1 RBCs stored for 35 days.",[89],"Healthy Subjects",[91,92,93,94,95,96,97,98,99,100],"INTERCEPT","Red Blood Cells","RBC","Pathogen Inactivation","Pathogen reduction","Cerus","Survival","Radiolabel","Autologous","Recovery","RECRUITING","2025-10-13",{"date":104,"type":40},"2025-10-15",{"date":106,"type":40},"2025-09-19",{"date":108,"type":21},"2026-10-15",{"name":46,"class":47},2,""]