[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639010":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":20,"locations":28,"responsibleParty":68,"collaborators":10,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":10,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":10,"enrollmentInfo":81,"targetDuration":10,"studyType":84,"phases":10,"briefSummary":85,"conditions":86,"keywords":93,"overallStatus":102,"whyStopped":10,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Queen's University","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Standardized hypovolemic phlebotomy protocol",null,"Adult patients at KHSC who are undergoing elective liver resection will receive hypovolemic phlebotomy (HP) in addition to standard anesthetic and surgical care. Following induction of general anesthesia and before hepatic resection, 10% of estimated total blood volume (approximately 7-10 mL\u002Fkg) will be removed via central venous access or a large bore peripheral venous line. Hemodynamic changes following phlebotomy will be managed using vasopressors \\[phenylephrine +\u002F- norepinephrine at the discretion of the attending anesthesiologist(s)\\] instead of routine IV crystalloid replacement. The goal is to maintain mean arterial pressure ≥65 mmHg. Serial physiologic monitoring will include arterial blood gases, lactate levels, urine output, and hemodynamic parameters at predefined timepoints (pre-phlebotomy after induction, post-phlebotomy, end of resection and in PACU). Autologous blood will be reinfused as needed if bleeding occurs prior to surgical closure (within 8 hours of collection).",{"label":13,"type":10,"description":14,"interventionNames":10},"Historical comparator cohort","A retrospective chart review will be conducted to assess the outcomes of previous elective liver resections prior to the introduction of hypovolemic phlebotomy at KHSC. This population will serve as a control cohort for our prospective data to document a structured hypovolemic phlebotomy approach that leads to measurable improvements in intraoperative management and perioperative outcomes. Data extracted will include demographics, indication for resection, baseline risk factors, operative variables (type and extent of resection, estimated blood loss, total fluid administered, vasopressor use including agent, dose, duration and any intraoperative transfusions of blood products). Postoperative outcomes will also be collected, including hemoglobin levels, total length of hospital stay, ICU admission (if applicable), total intraoperative blood product usage, 30- and 90- day mortality, and post-operative complications. The same exclusion criteria as the intervention group will be applied.",[16],{"name":17,"affiliation":18,"role":19},"Glenio Mizubuti, MD, PhD, FRCPC","Kingston Health Sciences Centre","PRINCIPAL_INVESTIGATOR",[21,25],{"name":17,"role":22,"phone":23,"phoneExt":10,"email":24},"CONTACT","(613) 548-7827","glenio.mizubuti@kingstonhsc.ca",{"name":26,"role":22,"phone":23,"phoneExt":10,"email":27},"Anthony M. H. Ho, MD, MSc, FRCPC","hoamh@hotmail.com",[29],{"facility":18,"status":10,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Kingston","Ontario","K7L 2V7","Canada","CA",{"type":36,"coordinates":37},"Point",[38,39],-76.48098,44.22976,{"lat":39,"lon":38},[42,45,47,50,52,54,56,58,60,62,64,66],{"name":43,"role":22,"phone":44,"phoneExt":10,"email":24},"Glenio Mizubuti, MD, FRCPC, PhD","+16135487827",{"name":46,"role":22,"phone":10,"phoneExt":10,"email":27},"Anthony Ho, MD, FRCPC, MSc",{"name":48,"role":49,"phone":10,"phoneExt":10,"email":10},"Sean Bennett, MD, MSc, FRCSC, FACS","SUB_INVESTIGATOR",{"name":51,"role":49,"phone":10,"phoneExt":10,"email":10},"Rachel Phelan, MSc",{"name":53,"role":49,"phone":10,"phoneExt":10,"email":10},"Jeannie Callum, MD, FRCSC",{"name":55,"role":49,"phone":10,"phoneExt":10,"email":10},"Jennifer Fleming, MD, FRCSC, MAS",{"name":57,"role":49,"phone":10,"phoneExt":10,"email":10},"Christopher Haley, MD, FRCSC, MScHQ",{"name":59,"role":49,"phone":10,"phoneExt":10,"email":10},"Jordan Leitch, MD, FRCSC, MSc",{"name":61,"role":49,"phone":10,"phoneExt":10,"email":10},"Sulaiman Nanji, MD, FRCSC",{"name":63,"role":49,"phone":10,"phoneExt":10,"email":10},"Emma Renard, MD, FRCSC",{"name":65,"role":49,"phone":10,"phoneExt":10,"email":10},"Steve Tresierra, MD, FRCSC",{"name":67,"role":49,"phone":10,"phoneExt":10,"email":10},"Anne Cao, BMsc",{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Dr. Glenio Mizubuti (MD, PhD, FRCPC)","Associate Professor, Department of Anesthesiology & Perioperative Medicine","100639010","reducing-red-blood-cell-transfusion-requirements-for-adults-undergoing-surgical-resection-of-the-liver---a-quality-improvement-project-100639010",false,"NCT07629648","Reducing Red Blood Cell Transfusion Requirements for Adults Undergoing Surgical Resection of the Liver - A Quality Improvement Project","Reducing Red Blood Cell Transfusion Requirements for Hepatectomy - A Quality Improvement Project","Inclusion Criteria:\n\n* Liver resection in this study is defined according to the PRICE-2 trial, involving 3 or more liver segments, such as right posterior sectionectomy (of segments VI and VII) as well as central resections involving segments IVb and V, along with expected blood loss of \\>250 mL\n* in patients with known liver cirrhosis, resection of a full segment was included.\n\nExclusion Criteria (defined according to the PRICE-2 trial):\n\n* current cardiac condition (e.g., MI within the last 6 months, hypertrophic cardiomyopathy, severe valvular disease, or other unstable coronary syndromes)\n* history of cerebrovascular disease (CVA within the past 6 months or severe carotid stenosis with more than 70% occlusion)\n* history of significant peripheral vascular disease (not yet revascularized with regular\u002Fongoing claudication)\n* A current pregnancy\n* A documented, patient-declared refusal to undergo phlebotomy and transfusion\n* preoperative autologous blood donation\n* presence of active infection\n* preoperative hemoglobin \\\u003C100 g\u002FL\n* GFR \\\u003C60 mL\u002Fmin\n* platelets count \\\u003C100 × 109\u002FL\n* Uncorrectable coagulopathies or other decompensated cardiac or respiratory conditions that would contraindicate acute volume depletion\n* undergoing emergency surgery\n* planned intraoperative use of cell salvage\n* inability to participate in follow up\n* in the case of repeat liver resections, previous participation in the trial","ALL","18 Years",{"count":82,"type":83},60,"ESTIMATED","OBSERVATIONAL","The goal of this clinical trial is to determine if implementing a controlled blood removal protocol (i.e. hypovolemic phlebotomy \\[HP\\] where approximately 10% of the patient's blood is removed and reinfused following hepatic resection as described in the PRICE-2 clinical trial) will reduce the rate of blood transfusions in liver resection surgery at Kingston Health Sciences Centre. Our goals (not included in the PRICE-2 trial) are as follows:\n\n* Improved monitoring of how the body responds during surgery following controlled blood removal. We will conduct blood tests to look at oxygen, carbon dioxide, lactate, and acid (pH) levels in the blood as well as urine output.\n* Standardized guidelines for how fluids and blood pressure medications are used during surgery to reduce blood loss and keep hemodynamics stable.\n* Monitor patients' recovery following surgery to track complications, injury to the heart, length of hospital stay, and outcomes for up to 90 days. We will also compare long-term recurrence rate of liver cancer compared to patients in the past at our site who did not receive the controlled blood removal (i.e., HP) prior to surgery.",[87,88,89,90,91,92],"Hepatectomy","Transfusion Requirements","Intraoperative Bleeding","Intraoperative Monitoring","Blood Cells Transfusion","Phlebotomy",[94,95,96,97,98,99,100,101],"hypovolemic phlebotomy","hepatectomy","Perioperative Care","erythrocyte transfusion","liver resection","transfusion requirements","therapeutic phlebotomy","intraoperative bleeding","NOT_YET_RECRUITING","2026-06-01",{"date":105,"type":106},"2026-06-05","ACTUAL",{"date":108,"type":83},"2026-06",{"date":110,"type":83},"2031-06",{"name":70,"class":6},1]