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

Official title

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

Overview

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.

Primary outcome measures

• Reduction of intraoperative red blood cell (RBC) transfusion rates. [Time frame: Perioperatively, from hospital admission to discharge.]

Secondary outcome measures (7)

• 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Canada · 1 center

• Kingston Health Sciences Centre — Kingston

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. PMID 31567574
• 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. PMID 25331016
• 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. PMID 27732721
• 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. PMID 28288056
• 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. PMID 25100209
• 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. PMID 20003061
• 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 undergoin PMID 39667380
• 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. PMID 31573678

Identifiers

NCT: NCT07629648 · 6045703

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗