An observational study in Hepatectomy, Transfusion Requirements and Intraoperative Bleeding, sponsored by Dr. Glenio Mizubuti (MD, PhD, FRCPC). Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by Dr. Glenio Mizubuti (MD, PhD, FRCPC) · 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:
218 studies on the registry are indexed under Blood Loss, Surgical; 39 are open to participants now.
This study's planned enrollment of 60 is below the median of 154 across 49 observational studies indexed under Blood Loss, Surgical.
Browse Blood Loss, Surgical studies →This is the only study on the registry with Dr. Glenio Mizubuti (MD, PhD, FRCPC) as lead sponsor.
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Adults aged ≥18 years undergoing elective hepatic resection at Kingston Health Sciences Centre.
Inclusion Criteria:
Exclusion Criteria (defined according to the PRICE-2 trial):
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/kg) will be removed via central venous access or a large bore peripheral venous line. Hemodynamic changes following phlebotomy will be managed using vasopressors \[phenylephrine +/- norepinephrine at the discretion of the attending anesthesiologist(s)\] 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).
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.
Reduction of intraoperative red blood cell (RBC) transfusion rates.
To change intraoperative transfusion rates (representing a 38% reduction based on PRICE-2 trial) in elective hepatectomies for cancer at KHSC upon implementation of a standardized hypovolemic phlebotomy protocol. In so doing, we aim to make our local transfusion rate in line with the average transfusion rate across centers in Ontario, Canada.
Time frame: Perioperatively, from hospital admission to discharge.
Rate of change in pH based on serial arterial blood gases during hepatectomy.
Intraoperative assessment of changes in pH based on serial arterial blood gases relative to the volume of blood removed during hepatectomy.
Time frame: Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
Rate of change in PaO2 and PaCO2 (mmHg) based on serial arterial blood gases during hepatectomy.
Intraoperative assessment of changes in PaO2 and PaCO2 (mmHg) levels based on serial arterial blood gases relative to the volume of blood removed during hepatectomy.
Time frame: Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
Rate of change in serum lactate (mmol/L) based on serial arterial blood gases during hepatectomy.
Intraoperative assessment of changes in lactate (mmol/L) levels based on serial arterial blood gases relative to the volume of blood removed during hepatectomy.
Time frame: Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
Rate of change in urine output (mL) during hepatectomy.
Intraoperative assessment of changes in urine output (mL) relative to the volume of blood removed during hepatectomy.
Time frame: Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
Total dose of vasopressors (ephedrine, phenylephrine, norepinephrine, epinephrine, vasopressin) required to maintain a mean arterial pressure (MAP) target of ≥65 mmHg intraoperatively during hypovolemic phlebotomy hepatectomy.
Track total dose (mg/mcg/units) of vasopressors (ephedrine, phenylephrine, norepinephrine, epinephrine, vasopressin) required intraoperatively to maintain a target MAP ≥65 mmHg during hypovolemic phlebotomy hepatectomy.
Time frame: Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
Incidence of in-hospital postoperative complications following hypovolemic phlebotomy.
Track postoperative (e.g., cardiovascular, respiratory, neurologic, renal, etc.) complications during hospital stay following hepatectomy.
Time frame: Perioperatively, from completion of surgery to hospital discharge.
Incidence of morbimortality at 90 days and 5 years following hypovolemic phlebotomy hepatectomy.
Track postoperative (cardiovascular, respiratory, neurologic, renal, etc.) complications as well as cancer recurrence at 90-day and 5-year postoperatively. Long-term (5-year) liver cancer recurrence will be compared to a historical local cohort as control. Measurement will be performed by phone call by research personnel.
Time frame: Postoperatively, from completion of surgery to 5 years post-operation.
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Plan to share: No — We will not be sharing individual participant data as it will be aggregated and deidentified.
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