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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorDr. Glenio Mizubuti (MD, PhD, FRCPC)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 2 trial groups
Group A: Standardized hypovolemic phlebotomy protocol
Group B: Historical comparator cohort

Trial outcomes

Primary outcomes

1

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

1

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.

Time frame
Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
2

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.

Time frame
Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
3

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.

Time frame
Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.
4

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.

Time frame
Intraoperatively, from induction of anesthesia to when patient is in the post-anesthetic care unit in the immediate postoperative period.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dr. Glenio Mizubuti (MD, PhD, FRCPC)

Lead sponsor

Queen's University

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: