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

N/ANot Yet RecruitingNCT07629648

Dr. Glenio Mizubuti (MD, PhD, FRCPC)60 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hepatectomy Transfusion Requirements Intraoperative Bleeding Intraoperative Monitoring Blood Cells Transfusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Perioperatively, from hospital admission to discharge.

Secondary Outcomes

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.