[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523471":3},{"organization":4,"outcomesModule":7,"designInfo":84,"detailedDescription":83,"studyPopulation":83,"armGroups":95,"interventions":112,"overallOfficials":83,"centralContacts":121,"locations":127,"responsibleParty":391,"collaborators":83,"id":393,"slug":394,"hasResults":395,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":83,"eligibilityCriteria":399,"healthyVolunteers":395,"sex":400,"minAge":401,"maxAge":402,"enrollmentInfo":403,"targetDuration":83,"studyType":406,"phases":407,"briefSummary":409,"conditions":410,"keywords":412,"overallStatus":130,"whyStopped":83,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":426},{"fullName":5,"class":6},"Octapharma","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":83},[9],{"measure":10,"description":11,"timeFrame":12},"Restoring heparin responsiveness","The percentage of patients in each group in whom no further therapy containing antithrombin (i.e. frozen plasma or other antithrombin concentrates) is needed for restoring pre-CPB heparin responsiveness after administration of Atenativ or placebo, and for maintaining it during CPB","During surgery (from the time of the first surgical incision to the time at which the final suture or staple is placed)",[14,17,21,25,29,33,37,41,44,47,51,55,58,62,66,70,74,76,78,81],{"measure":15,"description":16,"timeFrame":12},"Amounts of further therapy for restoring heparin responsiveness","The comparison between the amounts of further therapy containing antithrombin (i.e., FP or antithrombin concentrates) needed for restoring pre-CPB heparin responsiveness, after administration of Atenativ or placebo, and for maintaining it during CPB",{"measure":18,"description":19,"timeFrame":20},"Change in activated clotting time (ACT) values","The comparison between the change in ACT values following infusion of each of the Atenativ doses and placebo","Within 5 minutes following intravenous administration of 500 U\u002Fkg unfractionated heparin (UFH) and between 2-10 minutes after IMP infusion",{"measure":22,"description":23,"timeFrame":24},"Change in antithrombin plasma levels","The comparison between the change in antithrombin plasma levels following infusion of each of the Atenativ doses and placebo","Within 10 minutes before IMP infusion and between 2 and 10 minutes after IMP infusion, within 10 minutes after the end of CPB, at the end of surgery, and at 24 hours after the start of IMP infusion",{"measure":26,"description":27,"timeFrame":28},"Change in heparin usage","The comparison between heparin usage following the infusion of each of the Atenativ doses and infusion of placebo","From end of IMP infusion to the end of surgery",{"measure":30,"description":31,"timeFrame":32},"FP unit use","The comparison between the number of units of FP transfused for reasons other than restoring or maintaining heparin responsiveness, both intraoperatively (from the start of Atenativ or placebo infusion until the start of CPB, during CPB, and from the end of CPB until the end of surgery) and postoperatively (from the end of surgery until 24 hours after the start of Atenativ or placebo infusion and until discharge or 7 days after surgery, whichever comes first), as well as cumulatively","From the start of IMP infusion until 24 hours following IMP infusion, and until discharge or 7 days after surgery, whichever comes first",{"measure":34,"description":35,"timeFrame":36},"Amounts of further antithrombin concentrate for maintaining heparin responsiveness","The comparison between postoperative use of antithrombin concentrates for reasons other than restoring heparin responsiveness (from the end of surgery until 24 hours after the start of Atenativ or placebo infusion and until discharge or 7 days after surgery, whichever comes first)","From placement of the final suture or staple until 24 hours following IMP infusion, to discharge or 7 days after surgery, whichever comes first",{"measure":38,"description":39,"timeFrame":40},"Transfusion of allogenic blood products","The comparison between transfusion of other allogeneic blood products (e.g., red blood cells \\[RBCs\\], platelets, cryoprecipitate, whole blood, albumin, other transfusion), both intraoperatively (from the start of Atenativ or placebo infusion until the start of CPB, during CPB, and from the end of CPB until the end of surgery) and postoperatively (from the end of surgery until 24 hours after the start of Atenativ or placebo infusion and until discharge or 7 days after surgery, whichever comes first), as well as cumulatively","From the start of IMP infusion until 24 hours after the start of Atenativ or placebo infusion and until discharge or 7 days after surgery, whichever comes first",{"measure":42,"description":43,"timeFrame":40},"Administration of coagulation factor concentrates","The comparison between administration of coagulation factor concentrates (fibrinogen concentrate, factor XIII concentrate, recombinant activated factor VII, other therapy)\", both intraoperatively (from the start of Atenativ or placebo infusion until the start of CPB, during CPB, and from the end of CPB until the end of surgery) and postoperatively (from the end of surgery until 24 hours after the start of Atenativ or placebo infusion and until discharge or 7 days after surgery, whichever comes first), as well as cumulatively",{"measure":45,"description":46,"timeFrame":40},"Administration of other haemostatic-relevant therapies","The comparison between administration of other haemostatic-relevant therapies (i.e., tranexamic acid, aminocaproic acid, protamine, other therapies), both intraoperatively (from the start of Atenativ or placebo infusion until the start of CPB, during CPB, and from the end of CPB until the end of surgery) and postoperatively (from the end of surgery until 24 hours after the start of Atenativ or placebo infusion and until discharge or 7 days after surgery, whichever comes first), as well as cumulatively",{"measure":48,"description":49,"timeFrame":50},"Postoperative chest tube drainage","The comparison between postoperative chest tube drainage volume at 24 hours after the start of Atenativ or placebo infusion, and the comparison between total chest tube drainage volume until discharge or 7 days after surgery, whichever comes first","From the start of IMP infusion to 24 hours after infusion and until discharge or 7 days after surgery, whichever comes first",{"measure":52,"description":53,"timeFrame":54},"Need for reoperation due to bleeding","Comparison of the need for reoperation for bleeding, including description of the cause of bleeding (surgical vs. non-surgical)","24 hours after the start of IMP infusion",{"measure":56,"description":57,"timeFrame":12},"Cell saver volume","The comparison between cell saver volume until the end of surgery",{"measure":59,"description":60,"timeFrame":61},"Adverse events","Incidence of adverse events, including all related and non-related, non-serious adverse events","From the start of IMP infusion until hospital discharge or 7 days after IMP administration, whichever comes first",{"measure":63,"description":64,"timeFrame":65},"Serious adverse events","Incidence of serious adverse events","From the start of IMP infusion until 28 days after IMP administration",{"measure":67,"description":68,"timeFrame":69},"Survival status","Number of patients surviving in all three cohorts","At hospital discharge or 7 days after IMP administration (whichever comes first) and at 28 days (+ 4 days) after IMP administration",{"measure":71,"description":72,"timeFrame":73},"Red Blood Cell count","Standard haematological parameter","Within 10 minutes before IMP infusion, between 2-10 minutes after IMP infusion, within 10 minutes after the end of CPB, at the end of surgery, and at 24 hours after infusion",{"measure":75,"description":72,"timeFrame":73},"White Blood Cell count",{"measure":77,"description":72,"timeFrame":73},"Haemoglobin levels",{"measure":79,"description":72,"timeFrame":80},"Haematocrit","Within 10 minutes before IMP infusion, between 2-10 minutes after IMP infusion, within 10 minutes after weaning from CPB, at the end of surgery, and at 24 hours after infusion",{"measure":82,"description":72,"timeFrame":80},"Platelet count",null,{"allocation":85,"interventionModel":86,"interventionModelDescription":83,"primaryPurpose":87,"observationalModel":83,"timePerspective":83,"maskingInfo":88},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":89,"maskingDescription":90,"whoMasked":91},"TRIPLE","Triple (Participant, Care Provider, Outcomes Assessor) The patients, care provider administering IMP, and outcomes assessors will be blinded from treatment allocations. Delegated study personnel preparing the IMP will be unblinded.",[92,93,94],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR",[96,102,106],{"label":97,"type":98,"description":99,"interventionNames":100},"Low-dose Atenativ","EXPERIMENTAL","Patients will receive a single bolus of 30 international units (IU)\u002Fkg body weight (BW) Atenativ.",[101],"Drug: Human plasma derived antithrombin",{"label":103,"type":98,"description":104,"interventionNames":105},"High-dose Atenativ","Patients will receive a single bolus of 60 international units (IU)\u002Fkg body weight (BW) Atenativ.",[101],{"label":107,"type":108,"description":109,"interventionNames":110},"Placebo","PLACEBO_COMPARATOR","Patients will receive a saline bolus dose",[111],"Drug: Placebo",[113,118],{"type":114,"name":115,"description":116,"armGroupLabels":117,"otherNames":83},"DRUG","Human plasma derived antithrombin","A solvent\u002Fdetergent and heat-treated antithrombin concentrate derived from human plasma",[103,97],{"type":114,"name":107,"description":119,"armGroupLabels":120,"otherNames":83},"Half of the patients in the placebo group will be randomised to receive a volume of placebo corresponding to the low dose of Atenativ and the other half to receive a volume of placebo corresponding to a high dose of Atenativ",[107],[122],{"name":123,"role":124,"phone":125,"phoneExt":83,"email":126},"Cristina Solomon, MD","CONTACT","+41 79 585 90 42","Cristina.Solomon@octapharma.com",[128,142,152,162,172,181,191,200,210,220,230,238,250,260,270,280,289,298,308,317,327,335,345,355,365,375,383],{"facility":129,"status":130,"city":131,"state":132,"zip":133,"country":134,"countryCode":135,"cosmosGeoPoint":136,"geoPoint":141,"contacts":83},"Stanford University School of Medicine","RECRUITING","Stanford","California","94305-5101","United States","US",{"type":137,"coordinates":138},"Point",[139,140],-122.16608,37.42411,{"lat":140,"lon":139},{"facility":143,"status":130,"city":144,"state":145,"zip":146,"country":134,"countryCode":135,"cosmosGeoPoint":147,"geoPoint":151,"contacts":83},"University of Miami","Miami","Florida","33136",{"type":137,"coordinates":148},[149,150],-80.19366,25.77427,{"lat":150,"lon":149},{"facility":153,"status":130,"city":154,"state":155,"zip":156,"country":134,"countryCode":135,"cosmosGeoPoint":157,"geoPoint":161,"contacts":83},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":137,"coordinates":158},[159,160],-71.05977,42.35843,{"lat":160,"lon":159},{"facility":163,"status":130,"city":164,"state":165,"zip":166,"country":134,"countryCode":135,"cosmosGeoPoint":167,"geoPoint":171,"contacts":83},"Duke University Medical Center","Durham","North Carolina","27710-1000",{"type":137,"coordinates":168},[169,170],-78.89862,35.99403,{"lat":170,"lon":169},{"facility":173,"status":130,"city":174,"state":165,"zip":175,"country":134,"countryCode":135,"cosmosGeoPoint":176,"geoPoint":180,"contacts":83},"Atrium Health Wake Forest Baptist","Winston-Salem","27157",{"type":137,"coordinates":177},[178,179],-80.24422,36.09986,{"lat":179,"lon":178},{"facility":182,"status":130,"city":183,"state":184,"zip":185,"country":134,"countryCode":135,"cosmosGeoPoint":186,"geoPoint":190,"contacts":83},"Cleveland Clinic","Cleveland","Ohio","44195",{"type":137,"coordinates":187},[188,189],-81.69541,41.4995,{"lat":189,"lon":188},{"facility":192,"status":130,"city":193,"state":184,"zip":194,"country":134,"countryCode":135,"cosmosGeoPoint":195,"geoPoint":199,"contacts":83},"The Ohio State University","Columbus","43214",{"type":137,"coordinates":196},[197,198],-82.99879,39.96118,{"lat":198,"lon":197},{"facility":201,"status":130,"city":202,"state":203,"zip":204,"country":134,"countryCode":135,"cosmosGeoPoint":205,"geoPoint":209,"contacts":83},"OU Health University of Oklahoma Medical Center","Oklahoma City","Oklahoma","73104",{"type":137,"coordinates":206},[207,208],-97.51643,35.46756,{"lat":208,"lon":207},{"facility":211,"status":130,"city":212,"state":213,"zip":214,"country":134,"countryCode":135,"cosmosGeoPoint":215,"geoPoint":219,"contacts":83},"University of Texas Southwestern Medical Center","Dallas","Texas","75390",{"type":137,"coordinates":216},[217,218],-96.80667,32.78306,{"lat":218,"lon":217},{"facility":221,"status":130,"city":222,"state":83,"zip":83,"country":223,"countryCode":224,"cosmosGeoPoint":225,"geoPoint":229,"contacts":83},"University Hospital Innsbruck","Innsbruck","Austria","AT",{"type":137,"coordinates":226},[227,228],11.39454,47.26266,{"lat":228,"lon":227},{"facility":231,"status":130,"city":232,"state":83,"zip":83,"country":223,"countryCode":224,"cosmosGeoPoint":233,"geoPoint":237,"contacts":83},"Vienna General Hospital AKH, Medical University of Vienna","Vienna",{"type":137,"coordinates":234},[235,236],16.37208,48.20849,{"lat":236,"lon":235},{"facility":239,"status":130,"city":240,"state":241,"zip":242,"country":243,"countryCode":244,"cosmosGeoPoint":245,"geoPoint":249,"contacts":83},"Royal Columbian Hospital","New Westminster","British Columbia","V3L0A4","Canada","CA",{"type":137,"coordinates":246},[247,248],-122.91092,49.20678,{"lat":248,"lon":247},{"facility":251,"status":130,"city":252,"state":253,"zip":254,"country":243,"countryCode":244,"cosmosGeoPoint":255,"geoPoint":259,"contacts":83},"Kingston Health Sciences Centre","Kingston","Ontario","K7L2V7",{"type":137,"coordinates":256},[257,258],-76.48098,44.22976,{"lat":258,"lon":257},{"facility":261,"status":262,"city":263,"state":253,"zip":264,"country":243,"countryCode":244,"cosmosGeoPoint":265,"geoPoint":269,"contacts":83},"Toronto General Hospital","NOT_YET_RECRUITING","Toronto","M5G2C4",{"type":137,"coordinates":266},[267,268],-79.39864,43.70643,{"lat":268,"lon":267},{"facility":271,"status":130,"city":272,"state":273,"zip":274,"country":243,"countryCode":244,"cosmosGeoPoint":275,"geoPoint":279,"contacts":83},"Montreal Heart Institute","Montreal","Quebec","H1T1C8",{"type":137,"coordinates":276},[277,278],-73.58781,45.50884,{"lat":278,"lon":277},{"facility":281,"status":130,"city":282,"state":83,"zip":83,"country":283,"countryCode":83,"cosmosGeoPoint":284,"geoPoint":288,"contacts":83},"Center of Cardiovascular and Transplant Surgery","Brno","Czechia",{"type":137,"coordinates":285},[286,287],16.60796,49.19522,{"lat":287,"lon":286},{"facility":290,"status":291,"city":292,"state":83,"zip":83,"country":283,"countryCode":83,"cosmosGeoPoint":293,"geoPoint":297,"contacts":83},"Institute for Clinical and Experimental Medicine","TERMINATED","Prague",{"type":137,"coordinates":294},[295,296],14.42076,50.08804,{"lat":296,"lon":295},{"facility":299,"status":291,"city":300,"state":83,"zip":83,"country":301,"countryCode":302,"cosmosGeoPoint":303,"geoPoint":307,"contacts":83},"CHU de Reims, Hôpital Robert Debré","Reims","France","FR",{"type":137,"coordinates":304},[305,306],4.02853,49.26526,{"lat":306,"lon":305},{"facility":309,"status":310,"city":311,"state":83,"zip":83,"country":301,"countryCode":302,"cosmosGeoPoint":312,"geoPoint":316,"contacts":83},"CHU de Rennes","WITHDRAWN","Rennes",{"type":137,"coordinates":313},[314,315],-1.67431,48.11109,{"lat":315,"lon":314},{"facility":318,"status":291,"city":319,"state":83,"zip":83,"country":320,"countryCode":321,"cosmosGeoPoint":322,"geoPoint":326,"contacts":83},"Hospital of Lithuanian university of Health sciences Kauno Klinikos","Kaunas","Lithuania","LT",{"type":137,"coordinates":323},[324,325],23.90909,54.90156,{"lat":325,"lon":324},{"facility":328,"status":130,"city":329,"state":83,"zip":83,"country":320,"countryCode":321,"cosmosGeoPoint":330,"geoPoint":334,"contacts":83},"Vilnius University hospital Santaros Klinikos","Vilnius",{"type":137,"coordinates":331},[332,333],25.2798,54.68916,{"lat":333,"lon":332},{"facility":336,"status":130,"city":337,"state":83,"zip":83,"country":338,"countryCode":339,"cosmosGeoPoint":340,"geoPoint":344,"contacts":83},"Institute for Cardiovascular Diseases C.C. Iliescu","Bucharest","Romania","RO",{"type":137,"coordinates":341},[342,343],26.10626,44.43225,{"lat":343,"lon":342},{"facility":346,"status":130,"city":347,"state":83,"zip":83,"country":348,"countryCode":349,"cosmosGeoPoint":350,"geoPoint":354,"contacts":83},"Institute of Cardiovascular Diseases Vojvodina","Kamenitz","Serbia","RS",{"type":137,"coordinates":351},[352,353],19.84263,45.22334,{"lat":353,"lon":352},{"facility":356,"status":130,"city":357,"state":83,"zip":83,"country":358,"countryCode":359,"cosmosGeoPoint":360,"geoPoint":364,"contacts":83},"University Medical Centre Ljubljana","Ljubljana","Slovenia","SI",{"type":137,"coordinates":361},[362,363],14.50513,46.05108,{"lat":363,"lon":362},{"facility":366,"status":130,"city":367,"state":83,"zip":83,"country":368,"countryCode":369,"cosmosGeoPoint":370,"geoPoint":374,"contacts":83},"Royal Papworth Hospital","Cambridge","United Kingdom","UK",{"type":137,"coordinates":371},[372,373],0.11667,52.2,{"lat":373,"lon":372},{"facility":376,"status":130,"city":377,"state":83,"zip":83,"country":368,"countryCode":369,"cosmosGeoPoint":378,"geoPoint":382,"contacts":83},"University Hospital Coventry and Warwickshire","Coventry",{"type":137,"coordinates":379},[380,381],-1.51217,52.40656,{"lat":381,"lon":380},{"facility":384,"status":130,"city":385,"state":83,"zip":83,"country":368,"countryCode":369,"cosmosGeoPoint":386,"geoPoint":390,"contacts":83},"The James Cook University Hospital","Middlesbrough",{"type":137,"coordinates":387},[388,389],-1.23483,54.57623,{"lat":389,"lon":388},{"type":392,"investigatorFullName":83,"investigatorTitle":83,"investigatorAffiliation":83,"oldNameTitle":83,"oldOrganization":83},"SPONSOR","100523471","phase-3-phase-3-study-on-the-efficacy-and-safety-of-human-plasma-derived-antithrombin-atenativ-in-heparin-resistant-patients-scheduled-to-undergo-cardiac-surgery-necessitating-cardiopulmonary-bypass-100523471",false,"NCT06096116","Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass","Phase 3, Double-blind, Placebo-controlled, Multicentre Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass","Inclusion Criteria:\n\n1. Planned cardiac surgery with CPB\n2. Heparin-resistant patients (pre-CPB Hemochron ACT less than 480 s in the measurement taken between 2-5 minutes following intravenous administration of 500 U\u002Fkg UFH)\n3. Patients between 18 and 85 years of age, inclusive\n4. Freely given written or electronic informed consent\n5. In female patients of childbearing potential, a pre-existing negative pregnancy test within 14 days prior to surgery\n\nExclusion Criteria:\n\n1. Receiving, or have received within the timeframes specified, one or more of the following medications prior to the start of surgery:\n\n   1. vitamin K antagonists (within 3 days)\n   2. direct oral anticoagulants (within 2 days)\n   3. thienopyridines (ticlopidine within 14 days, prasugrel within 7 days, or clopidogrel within 5 days), unless platelet function is satisfactory according to local standard of care assessment\n   4. ticagrelor (within 5 days), unless platelet function is satisfactory according to local standard of care assessment\n   5. glycoprotein IIb\u002FIIIa antagonist (within 24 hours)\n2. Pre-existing coagulopathy, a history of bleeding problems, or a laboratory-diagnosed bleeding disorder (e.g., von Willebrand disease, platelet disorder)\n3. Renal insufficiency, defined as serum creatinine level \\>2.0 mg\u002FdL\n4. Thrombocytosis, defined as platelet count \\>400,000 per μL\n5. Known hypersensitivity or allergic reaction to antithrombin or any of the excipients in Atenativ, i.e., human albumin, sodium chloride, acetyl tryptophan, caprylic acid\n6. History of anaphylactic reaction(s) to blood or blood components\n7. Refusal to receive transfusion of blood or blood-derived products\n8. Current participation in another interventional clinical trial or previous participation in the current trial\n9. Treatment with any IMP within 30 days prior to screening visit","ALL","18 Years","85 Years",{"count":404,"type":405},120,"ESTIMATED","INTERVENTIONAL",[408],"PHASE3","The primary objective of this study is to evaluate the efficacy of two different doses of Atenativ, versus placebo, in restoring and maintaining heparin responsiveness in adult patients undergoing cardiac surgery necessitating cardiopulmonary bypass (CPB)",[411],"Acquired Antithrombin Deficiency",[413,414,415,416],"heparin resistance","antithrombin deficiency","cardiopulmonary bypass","cardiac surgery","2026-09-23",{"date":419,"type":420},"2026-09-28","ACTUAL",{"date":422,"type":420},"2024-08-21",{"date":424,"type":405},"2028-03",{"name":5,"class":6},27]