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

2026年6月1日 更新者：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.

調査の概要

状態

まだ募集していません

条件

研究の種類

観察的

入学 (推定)

60

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

  • 名前：Anthony M. H. Ho, MD, MSc, FRCPC
  • 電話番号：(613) 548-7827
  • メール：hoamh@hotmail.com

研究場所

  • カナダ
    • Ontario
      • Kingston、Ontario、カナダ、K7L 2V7
        • Kingston Health Sciences Centre
        • コンタクト：
        • コンタクト：
        • 副調査官：
          • Sean Bennett, MD, MSc, FRCSC, FACS
        • 副調査官：
          • Rachel Phelan, MSc
        • 副調査官：
          • Jeannie Callum, MD, FRCSC
        • 副調査官：
          • Jennifer Fleming, MD, FRCSC, MAS
        • 副調査官：
          • Christopher Haley, MD, FRCSC, MScHQ
        • 副調査官：
          • Jordan Leitch, MD, FRCSC, MSc
        • 副調査官：
          • Sulaiman Nanji, MD, FRCSC
        • 副調査官：
          • Emma Renard, MD, FRCSC
        • 副調査官：
          • Steve Tresierra, MD, FRCSC
        • 副調査官：
          • Anne Cao, BMsc

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Reduction of intraoperative red blood cell (RBC) transfusion rates.
時間枠：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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Rate of change in pH based on serial arterial blood gases during hepatectomy.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Dr. Glenio Mizubuti (MD, PhD, FRCPC)

捜査官

  • 主任研究者：Glenio Mizubuti, MD, PhD, FRCPC、Kingston Health Sciences Centre

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月1日

一次修了 (推定)

2028年6月1日

研究の完了 (推定)

2031年6月1日

試験登録日

最初に提出

2026年5月25日

QC基準を満たした最初の提出物

2026年6月1日

最初の投稿 (実際)

2026年6月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月5日

QC基準を満たした最後の更新が送信されました

2026年6月1日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 6045703

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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

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いいえ

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