Reducing Red Blood Cell Transfusion Requirements for Adults Undergoing Surgical Resection of the Liver - A Quality Improvement Project
1. Juni 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Studientyp
Beobachtungs
Einschreibung (Geschätzt)
60
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Glenio Mizubuti, MD, PhD, FRCPC
- Telefonnummer: (613) 548-7827
- E-Mail: glenio.mizubuti@kingstonhsc.ca
Studieren Sie die Kontaktsicherung
- Name: Anthony M. H. Ho, MD, MSc, FRCPC
- Telefonnummer: (613) 548-7827
- E-Mail: hoamh@hotmail.com
Studienorte
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Ontario
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Kingston, Ontario, Kanada, K7L 2V7
- Kingston Health Sciences Centre
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Kontakt:
- Glenio Mizubuti, MD, FRCPC, PhD
- Telefonnummer: +16135487827
- E-Mail: glenio.mizubuti@kingstonhsc.ca
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Kontakt:
- Anthony Ho, MD, FRCPC, MSc
- E-Mail: hoamh@hotmail.com
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Unterermittler:
- Sean Bennett, MD, MSc, FRCSC, FACS
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Unterermittler:
- Rachel Phelan, MSc
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Unterermittler:
- Jeannie Callum, MD, FRCSC
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Unterermittler:
- Jennifer Fleming, MD, FRCSC, MAS
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Unterermittler:
- Christopher Haley, MD, FRCSC, MScHQ
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Unterermittler:
- Jordan Leitch, MD, FRCSC, MSc
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Unterermittler:
- Sulaiman Nanji, MD, FRCSC
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Unterermittler:
- Emma Renard, MD, FRCSC
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Unterermittler:
- Steve Tresierra, MD, FRCSC
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Unterermittler:
- Anne Cao, BMsc
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
Adults aged ≥18 years undergoing elective hepatic resection at Kingston Health Sciences Centre.
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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).
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Reduction of intraoperative red blood cell (RBC) transfusion rates.
Zeitfenster: Perioperatively, from hospital admission to discharge.
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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.
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Perioperatively, from hospital admission to discharge.
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Rate of change in pH based on serial arterial blood gases during hepatectomy.
Zeitfenster: Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
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Intraoperative assessment of changes in pH based on serial arterial blood gases relative to the volume of blood removed during hepatectomy.
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Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
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Rate of change in PaO2 and PaCO2 (mmHg) based on serial arterial blood gases during hepatectomy.
Zeitfenster: Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
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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.
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Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
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Rate of change in serum lactate (mmol/L) based on serial arterial blood gases during hepatectomy.
Zeitfenster: Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
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Intraoperative assessment of changes in lactate (mmol/L) levels based on serial arterial blood gases relative to the volume of blood removed during hepatectomy.
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Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
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Rate of change in urine output (mL) during hepatectomy.
Zeitfenster: Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
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Intraoperative assessment of changes in urine output (mL) relative to the volume of blood removed during hepatectomy.
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Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
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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.
Zeitfenster: Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
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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.
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Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
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Incidence of in-hospital postoperative complications following hypovolemic phlebotomy.
Zeitfenster: Perioperatively, from completion of surgery to hospital discharge.
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Track postoperative (e.g., cardiovascular, respiratory, neurologic, renal, etc.) complications during hospital stay following hepatectomy.
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Perioperatively, from completion of surgery to hospital discharge.
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Incidence of morbimortality at 90 days and 5 years following hypovolemic phlebotomy hepatectomy.
Zeitfenster: Postoperatively, from completion of surgery to 5 years post-operation.
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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.
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Postoperatively, from completion of surgery to 5 years post-operation.
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Glenio Mizubuti, MD, PhD, FRCPC, Kingston Health Sciences Centre
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Juni 2026
Primärer Abschluss (Geschätzt)
1. Juni 2028
Studienabschluss (Geschätzt)
1. Juni 2031
Studienanmeldedaten
Zuerst eingereicht
25. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
1. Juni 2026
Zuerst gepostet (Tatsächlich)
5. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
5. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
1. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 6045703
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We will not be sharing individual participant data as it will be aggregated and deidentified.
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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