[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644603":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":27,"locations":33,"responsibleParty":47,"collaborators":51,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":26,"enrollmentInfo":63,"targetDuration":26,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":75,"overallStatus":81,"whyStopped":26,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Stanford University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Restrictive Threshold (Control)","ACTIVE_COMPARATOR","Beginning on arrival to the cardiac ICU after surgery, transfusion of red blood cells is generally recommended when hemoglobin is below 7.5 g\u002FdL, consistent with current institutional practice and major restrictive-threshold trials. Standard surgical, anesthesia, perfusion, monitoring, and postoperative care are provided to all participants.",[13],"Other: Demand-Informed Transfusion Decision Rule",{"label":15,"type":16,"description":17,"interventionNames":18},"Demand-Informed (Personalized) Strategy (Experimental)","EXPERIMENTAL","Beginning on arrival to the cardiac ICU, an absolute safety floor recommends transfusion when hemoglobin is below 7.0 g\u002FdL regardless of physiology. Between 7.0 and 7.5 g\u002FdL, transfusion decisions are guided by predefined physiologic markers of oxygen balance (e.g., indexed oxygen delivery, venous oxygen saturation, lactate trends): transfusion may be deferred when markers indicate adequate oxygen delivery and is recommended when markers indicate compromised delivery. At or above 7.5 g\u002FdL the rule does not recommend transfusion. The rule is advisory; clinicians may override at any time, and overrides are recorded.",[13],[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Demand-Informed Transfusion Decision Rule","A deterministic, rules-based clinical decision aid that operationalizes the assigned ICU transfusion strategy using values already collected in routine care. It contains no trained model or machine learning; it is advisory and can be hand-executed at the bedside.",[15,9],[25],"Personalized transfusion strategy",null,[28],{"name":29,"role":30,"phone":31,"phoneExt":26,"email":32},"Yan Min, MD, PhD","CONTACT","650-666-9504","yanmin@stanford.edu",[34],{"facility":35,"status":26,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":26},"Stanford University Medical Center","Palo Alto","California","94305","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-122.14302,37.44188,{"lat":45,"lon":44},{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Yan Mia Min","Protocol Director",[52],{"name":5,"class":6},"100644603","personalized-blood-transfusion-protocol-for-cardiac-patients-100644603",false,"NCT07671469","Personalized Blood Transfusion Protocol for Cardiac Patients","Personalized (Demand-Informed) Blood Transfusion Protocol for Cardiac Patients","PerP","Inclusion Criteria:\n\n* Adults 18 years or older scheduled for cardiac surgery using the heart-lung machine (cardiopulmonary bypass), such as bypass, valve, or combined procedures\n* Moderate-to-high surgical risk (e.g., EuroSCORE II ≥ 3% or equivalent)\n* Allogeneic red blood cell transfusion is considered likely\n* Able to provide informed consent and understand randomization to different transfusion thresholds\n* Willing to receive blood products and follow study transfusion thresholds from anesthesia induction until hospital discharge or day 28, whichever comes first\n\nExclusion Criteria:\n\n* Refusal of or contraindication to allogeneic blood (e.g., Jehovah's Witness or formal directive against transfusion), or enrollment in a preoperative autologous donation program\n* Emergency or salvage procedures where protocol triggers are impractical (e.g., active arrest, aortic dissection with collapse)\n* Heart transplantation, durable ventricular assist device implantation, or surgery solely for VAD insertion\n* Off-pump bypass or other procedures not using cardiopulmonary bypass\n* Severe preoperative anemia (e.g., hemoglobin \\\u003C 8 g\u002FdL) or chronic transfusion-dependent anemia\n* Conditions preventing protocol adherence (e.g., anticipated massive hemorrhage, known bleeding disorder, very low platelets, uninterruptible dual antiplatelet\u002Fanticoagulant therapy)\n* Chronic dialysis dependence or established end-stage renal disease (eGFR \\\u003C 15 mL\u002Fmin\u002F1.73m² or on maintenance renal replacement therapy) prior to surgery.\n* Pregnancy or lactation\n* Enrollment in another interventional trial affecting transfusion practice or hemoglobin thresholds\n* Unable to provide informed consent (e.g., severe cognitive impairment without a legally authorized representative)","ALL","18 Years",{"count":64,"type":65},900,"ESTIMATED","INTERVENTIONAL",[68],"NA","This study compares two accepted ways of deciding when adults recovering from open-heart surgery should receive a blood transfusion in the intensive care unit. One approach gives a transfusion when the blood count (hemoglobin) falls below a fixed level that is the same for everyone. The other approach adds each patient's own physiology - such as oxygen levels and lactate - to help decide whether a transfusion is truly needed, within a safe range. The investigators want to learn whether the personalized approach is as safe as the standard approach for major outcomes after heart surgery, while reducing the amount of blood transfused. Participants may also choose to give blood and stool samples to a research biobank for future studies on recovery after cardiac surgery.",[71,72,73,74],"Cardiac Surgery","Blood Transfusion","Anemia","Cardiopulmonary Bypass",[76,77,78,79,80],"restrictive transfusion","hemoglobin trhreshold","oxygen delivery","cardiac surgery","ICU","NOT_YET_RECRUITING","2026-06-26",{"date":84,"type":85},"2026-06-30","ACTUAL",{"date":87,"type":65},"2026-09-14",{"date":89,"type":65},"2030-03-15",{"name":49,"class":6},1]