HepatectomyNCT07629648
Reducing Red Blood Cell Transfusion Requirements for Adults Undergoing Surgical Resection of the Liver - A Quality Improvement Project
An observational study of Hepatectomy and Transfusion Requirements, run by Dr. Glenio Mizubuti (MD, PhD, FRCPC) at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatectomy, Transfusion Requirements, Intraoperative Bleeding
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2026to Jun 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged ≥18 years undergoing elective hepatic resection at Kingston Health Sciences Centre.
Who may be able to join
- 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)
Show all 18Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
Glenio Mizubuti, MD, FRCPC, PhD, +16135487827, glenio.mizubuti@kingstonhsc.ca
Anthony Ho, MD, FRCPC, MSc, hoamh@hotmail.com
About this study
Official title: 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.
- Conditions
- Hepatectomy, Transfusion Requirements, Intraoperative Bleeding, Intraoperative Monitoring, Blood Cells Transfusion, Phlebotomy
- Keywords
- hypovolemic phlebotomy, hepatectomy, Perioperative Care, erythrocyte transfusion, liver resection, transfusion requirements, therapeutic phlebotomy, intraoperative bleeding
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Perioperatively, from hospital admission to discharge.
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Postoperatively, from completion of surgery to 5 years post-operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HepatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Glenio Mizubuti (MD, PhD, FRCPC)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Glenio Mizubuti (MD, PhD, FRCPC), Queen's University
- Investigators
- Glenio Mizubuti, MD, PhD, FRCPC, Principal investigator, Kingston Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629648
- Sponsor's protocol ID
- 6045703
- Status last verified
- Jun 2026
- First submitted
- 25 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not be sharing individual participant data as it will be aggregated and deidentified.
Publications
Bonnet A, Gilquin N, Steer N, Gazon M, Quattrone D, Pradat P, Maynard M, Mabrut JY, Aubrun F. The use of a thromboelastometry-based algorithm reduces the need for blood product transfusion during orthotopic liver transplantation: A randomised controlled study. Eur J Anaesthesiol. 2019 Nov;36(11):825-833. doi: 10.1097/EJA.0000000000001084.
PubMed 31567574Roullet S, Freyburger G, Cruc M, Quinart A, Stecken L, Audy M, Chiche L, Sztark F. Management of bleeding and transfusion during liver transplantation before and after the introduction of a rotational thromboelastometry-based algorithm. Liver Transpl. 2015 Feb;21(2):169-79. doi: 10.1002/lt.24030. Epub 2015 Jan 12.
PubMed 25331016Carson JL, Guyatt G, Heddle NM, Grossman BJ, Cohn CS, Fung MK, Gernsheimer T, Holcomb JB, Kaplan LJ, Katz LM, Peterson N, Ramsey G, Rao SV, Roback JD, Shander A, Tobian AA. Clinical Practice Guidelines From the AABB: Red Blood Cell Transfusion Thresholds and Storage. JAMA. 2016 Nov 15;316(19):2025-2035. doi: 10.1001/jama.2016.9185.
PubMed 27732721Bennett S, Tinmouth A, McIsaac DI, English S, Hebert PC, Karanicolas PJ, Turgeon AF, Barkun J, Pawlik TM, Fergusson D, Martel G. Ottawa Criteria for Appropriate Transfusions in Hepatectomy: Using the RAND/UCLA Appropriateness Method. Ann Surg. 2018 Apr;267(4):766-774. doi: 10.1097/SLA.0000000000002205.
PubMed 28288056Callum JL, Waters JH, Shaz BH, Sloan SR, Murphy MF. The AABB recommendations for the Choosing Wisely campaign of the American Board of Internal Medicine. Transfusion. 2014 Sep;54(9):2344-52. doi: 10.1111/trf.12802. Epub 2014 Aug 6. No abstract available.
PubMed 25100209Shander A, Hofmann A, Ozawa S, Theusinger OM, Gombotz H, Spahn DR. Activity-based costs of blood transfusions in surgical patients at four hospitals. Transfusion. 2010 Apr;50(4):753-65. doi: 10.1111/j.1537-2995.2009.02518.x. Epub 2009 Dec 9.
PubMed 20003061Martel G, Carrier FM, Wherrett C, Lenet T, Mallette K, Brousseau K, Monette L, Workneh A, Ruel M, Sabri E, Maddison H, Tokessy M, Wong PBY, Vandenbroucke-Menu F, Massicotte L, Chasse M, Collin Y, Perrault MA, Hamel-Perreault E, Park J, Lim S, Maltais V, Leung P, Gilbert RWD, Segedi M, Khalil JA, Bertens KA, Balaa FK, Ramsay T, Tinmouth A, Fergusson DA. Hypovolaemic phlebotomy in patients undergoing hepatic resection at higher risk of blood loss (PRICE-2): a randomised controlled trial. Lancet Gastroenterol Hepatol. 2025 Feb;10(2):114-124. doi: 10.1016/S2468-1253(24)00307-8. Epub 2024 Dec 9.
PubMed 39667380Tai YH, Wu HL, Mandell MS, Tsou MY, Chang KY. The association of allogeneic blood transfusion and the recurrence of hepatic cancer after surgical resection. Anaesthesia. 2020 Apr;75(4):464-471. doi: 10.1111/anae.14862. Epub 2019 Oct 1.
PubMed 31573678
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Red Blood Cell Transfusion Requirements for Hepatectomy - A Quality Improvement Project
- ClinicalTrials.gov ID
- NCT07629648
- Acronym / sponsor ID
- 6045703
- Conditions
- Hepatectomy, Transfusion Requirements, Intraoperative Bleeding, Intraoperative Monitoring, Blood Cells Transfusion, Phlebotomy
- Keywords
- hypovolemic phlebotomy, hepatectomy, Perioperative Care, erythrocyte transfusion, liver resection, transfusion requirements, therapeutic phlebotomy, intraoperative bleeding
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dr. Glenio Mizubuti (MD, PhD, FRCPC)University, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged ≥18 years undergoing elective hepatic resection at Kingston Health Sciences Centre.
Key inclusion criteria (18 listed)
- 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.
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
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.
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.
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.
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.
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.
Incidence of in-hospital postoperative complications following hypovolemic phlebotomy.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Background: PubMed 31567574Bonnet A, Gilquin N, Steer N, Gazon M, Quattrone D, Pradat P, Maynard M, Mabrut JY, Aubrun F. The use of a thromboelastometry-based algorithm reduces the need for blood product transfusion during orthotopic liver transplantation: A randomised controlled study. Eur J Anaesthesiol. 2019 Nov;36(11):825-833. doi: 10.1097/EJA.0000000000001084.
- Background: PubMed 25331016Roullet S, Freyburger G, Cruc M, Quinart A, Stecken L, Audy M, Chiche L, Sztark F. Management of bleeding and transfusion during liver transplantation before and after the introduction of a rotational thromboelastometry-based algorithm. Liver Transpl. 2015 Feb;21(2):169-79. doi: 10.1002/lt.24030. Epub 2015 Jan 12.
- Background: PubMed 27732721Carson JL, Guyatt G, Heddle NM, Grossman BJ, Cohn CS, Fung MK, Gernsheimer T, Holcomb JB, Kaplan LJ, Katz LM, Peterson N, Ramsey G, Rao SV, Roback JD, Shander A, Tobian AA. Clinical Practice Guidelines From the AABB: Red Blood Cell Transfusion Thresholds and Storage. JAMA. 2016 Nov 15;316(19):2025-2035. doi: 10.1001/jama.2016.9185.
- Background: PubMed 28288056Bennett S, Tinmouth A, McIsaac DI, English S, Hebert PC, Karanicolas PJ, Turgeon AF, Barkun J, Pawlik TM, Fergusson D, Martel G. Ottawa Criteria for Appropriate Transfusions in Hepatectomy: Using the RAND/UCLA Appropriateness Method. Ann Surg. 2018 Apr;267(4):766-774. doi: 10.1097/SLA.0000000000002205.
- Background: PubMed 25100209Callum JL, Waters JH, Shaz BH, Sloan SR, Murphy MF. The AABB recommendations for the Choosing Wisely campaign of the American Board of Internal Medicine. Transfusion. 2014 Sep;54(9):2344-52. doi: 10.1111/trf.12802. Epub 2014 Aug 6. No abstract available.
- Results publication: PubMed 20003061Shander A, Hofmann A, Ozawa S, Theusinger OM, Gombotz H, Spahn DR. Activity-based costs of blood transfusions in surgical patients at four hospitals. Transfusion. 2010 Apr;50(4):753-65. doi: 10.1111/j.1537-2995.2009.02518.x. Epub 2009 Dec 9.
- Results publication: PubMed 39667380Martel G, Carrier FM, Wherrett C, Lenet T, Mallette K, Brousseau K, Monette L, Workneh A, Ruel M, Sabri E, Maddison H, Tokessy M, Wong PBY, Vandenbroucke-Menu F, Massicotte L, Chasse M, Collin Y, Perrault MA, Hamel-Perreault E, Park J, Lim S, Maltais V, Leung P, Gilbert RWD, Segedi M, Khalil JA, Bertens KA, Balaa FK, Ramsay T, Tinmouth A, Fergusson DA. Hypovolaemic phlebotomy in patients undergoing hepatic resection at higher risk of blood loss (PRICE-2): a randomised controlled trial. Lancet Gastroenterol Hepatol. 2025 Feb;10(2):114-124. doi: 10.1016/S2468-1253(24)00307-8. Epub 2024 Dec 9.
- Results publication: PubMed 31573678Tai YH, Wu HL, Mandell MS, Tsou MY, Chang KY. The association of allogeneic blood transfusion and the recurrence of hepatic cancer after surgical resection. Anaesthesia. 2020 Apr;75(4):464-471. doi: 10.1111/anae.14862. Epub 2019 Oct 1.
- Individual participant dataSharing planned: No. We will not be sharing individual participant data as it will be aggregated and deidentified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Glenio Mizubuti, MD, PhD, FRCPC principal investigator
Kingston Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatectomy and Transfusion Requirements, run by Dr. Glenio Mizubuti (MD, PhD, FRCPC) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Glenio Mizubuti, MD, PhD, FRCPC ((613) 548-7827, glenio.mizubuti@kingstonhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of intraoperative red blood cell (RBC) transfusion rates. (time frame: Perioperatively, from hospital admission to discharge.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07629648, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.