Reducing Red Blood Cell Transfusion Requirements for Adults Undergoing Surgical Resection of the Liver - A Quality Improvement Project

June 1, 2026 updated by: Dr. Glenio Mizubuti (MD, PhD, FRCPC)

Reducing Red Blood Cell Transfusion Requirements for Hepatectomy - A Quality Improvement Project

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:

  • 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.
  • Standardized guidelines for how fluids and blood pressure medications are used during surgery to reduce blood loss and keep hemodynamics stable.
  • 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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Anthony M. H. Ho, MD, MSc, FRCPC
  • Phone Number: (613) 548-7827
  • Email: hoamh@hotmail.com

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston Health Sciences Centre
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sean Bennett, MD, MSc, FRCSC, FACS
        • Sub-Investigator:
          • Rachel Phelan, MSc
        • Sub-Investigator:
          • Jeannie Callum, MD, FRCSC
        • Sub-Investigator:
          • Jennifer Fleming, MD, FRCSC, MAS
        • Sub-Investigator:
          • Christopher Haley, MD, FRCSC, MScHQ
        • Sub-Investigator:
          • Jordan Leitch, MD, FRCSC, MSc
        • Sub-Investigator:
          • Sulaiman Nanji, MD, FRCSC
        • Sub-Investigator:
          • Emma Renard, MD, FRCSC
        • Sub-Investigator:
          • Steve Tresierra, MD, FRCSC
        • Sub-Investigator:
          • Anne Cao, BMsc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults aged ≥18 years undergoing elective hepatic resection at Kingston Health Sciences Centre.

Description

Inclusion Criteria:

  • 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
  • in patients with known liver cirrhosis, resection of a full segment was included.

Exclusion Criteria (defined according to the PRICE-2 trial):

  • current cardiac condition (e.g., MI within the last 6 months, hypertrophic cardiomyopathy, severe valvular disease, or other unstable coronary syndromes)
  • history of cerebrovascular disease (CVA within the past 6 months or severe carotid stenosis with more than 70% occlusion)
  • history of significant peripheral vascular disease (not yet revascularized with regular/ongoing claudication)
  • A current pregnancy
  • A documented, patient-declared refusal to undergo phlebotomy and transfusion
  • preoperative autologous blood donation
  • presence of active infection
  • preoperative hemoglobin <100 g/L
  • GFR <60 mL/min
  • platelets count <100 × 109/L
  • Uncorrectable coagulopathies or other decompensated cardiac or respiratory conditions that would contraindicate acute volume depletion
  • undergoing emergency surgery
  • planned intraoperative use of cell salvage
  • inability to participate in follow up
  • in the case of repeat liver resections, previous participation in the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Standardized hypovolemic phlebotomy protocol
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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of intraoperative red blood cell (RBC) transfusion rates.
Time Frame: Perioperatively, from hospital admission to discharge.
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.
Perioperatively, from hospital admission to discharge.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of change in pH based on serial arterial blood gases during hepatectomy.
Time Frame: Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
Intraoperative assessment of changes in pH based on serial arterial blood gases relative to the volume of blood removed during hepatectomy.
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.
Time Frame: Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
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.
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.
Time Frame: Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
Intraoperative assessment of changes in lactate (mmol/L) levels based on serial arterial blood gases relative to the volume of blood removed during hepatectomy.
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.
Time Frame: Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
Intraoperative assessment of changes in urine output (mL) relative to the volume of blood removed during hepatectomy.
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.
Time Frame: Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
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.
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.
Time Frame: Perioperatively, from completion of surgery to hospital discharge.
Track postoperative (e.g., cardiovascular, respiratory, neurologic, renal, etc.) complications during hospital stay following hepatectomy.
Perioperatively, from completion of surgery to hospital discharge.
Incidence of morbimortality at 90 days and 5 years following hypovolemic phlebotomy hepatectomy.
Time Frame: Postoperatively, from completion of surgery to 5 years post-operation.
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.
Postoperatively, from completion of surgery to 5 years post-operation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Glenio Mizubuti (MD, PhD, FRCPC)

Investigators

  • Principal Investigator: Glenio Mizubuti, MD, PhD, FRCPC, Kingston Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2031

Study Registration Dates

First Submitted

May 25, 2026

First Submitted That Met QC Criteria

June 1, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6045703

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will not be sharing individual participant data as it will be aggregated and deidentified.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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