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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Perioperatively, from hospital admission to discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period. |
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Inclusion Criteria:
Exclusion Criteria (defined according to the PRICE-2 trial):
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Adults aged ≥18 years undergoing elective hepatic resection at Kingston Health Sciences Centre.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Glenio Mizubuti, MD, PhD, FRCPC | Contact | (613) 548-7827 | glenio.mizubuti@kingstonhsc.ca | |
| Anthony M. H. Ho, MD, MSc, FRCPC | Contact | (613) 548-7827 | hoamh@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Glenio Mizubuti, MD, PhD, FRCPC | Kingston Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kingston Health Sciences Centre | Kingston | Ontario | K7L 2V7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31567574 | Background | 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. | |
| 25331016 |
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We will not be sharing individual participant data as it will be aggregated and deidentified.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 30, 2025 | May 14, 2026 |
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| 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. | 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. | 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. | 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. | 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. | 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. | Postoperatively, from completion of surgery to 5 years post-operation. |
| Roullet 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. |
| 27732721 | Background | Carson 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. |
| 28288056 | Background | Bennett 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. |
| 25100209 | Background | Callum 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. |
| 20003061 | Result | Shander 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. |
| 39667380 | Result | Martel 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. |
| 31573678 | Result | Tai 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. |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 19, 2026 | May 14, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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