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Hypovolemic Phlebotomy for Liver Resection (PRICE2 Trial)

N/A

Waitlist Available

Led By Guillaume Martel, MD, MSc, FRCSC, FACS

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult patients (≥18 years) projected to undergo a major liver resection (≥3 segments resected or partially resected), a right posterior sectionectomy (segments 6/7), or central resection (4b/5) for any indication, or the resection of 1 or more segments in a known cirrhotic patient.

Be older than 18 years old

Must not have

Abnormal coagulation parameters (not on warfarin and/or platelets count <100 X10^9/L)

Evidence of hepatic metabolic disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured during surgery (intraoperatively)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether taking blood before surgery can reduce blood loss and the need for transfusions during major liver surgery.

Who is the study for?

This trial is for adults over 18 who need major liver surgery, like removing at least three segments of the liver or operating on a cirrhotic liver. It's not for those under 18, with low hemoglobin or kidney function, abnormal blood clotting (not due to warfarin), recent heart issues, severe strokes or artery disease in the past six months, pregnant women, those refusing blood products, with active infections or who donated their own blood pre-surgery.

What is being tested?

The study tests if taking some blood out before surgery (hypovolemic phlebotomy) can lower central venous pressure and reduce bleeding during major liver resections. The goal is to see if this leads to fewer needed blood transfusions by creating a state of controlled low blood volume.

What are the potential side effects?

Potential side effects may include symptoms related to low blood volume such as dizziness, weakness, fainting especially when standing up quickly after lying down (orthostatic hypotension), and possibly reduced oxygen delivery to organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am an adult scheduled for a major liver surgery or have cirrhosis and need part of my liver removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My blood does not clot properly and I am not on warfarin with a low platelet count.

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I have a liver disorder that affects how my body processes substances.

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I have not had a heart attack or severe heart issues in the last 6 months.

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I have had a major stroke or severe narrowing of my neck arteries in the last 6 months.

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I have severe leg circulation problems that have not been treated with surgery.

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I am under 18 years old.

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My kidney function is reduced.

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I refuse to receive blood transfusions.

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I currently have an active infection.

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I have donated my own blood before surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured during surgery (intraoperatively)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured during surgery (intraoperatively)

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured during surgery (intraoperatively) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Packed Red Blood Cell Transfusion Rates

Secondary study objectives

Blood product transfusion rates

Changes in physiologic parameters (Central Venous Pressure)

Changes in physiologic parameters (Pulse Pressure Variation)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Hypovolemic PhlebotomyExperimental Treatment1 Intervention

Hypovolemic Phlebotomy will consist of the withdrawal of 7-10 mL/kg of whole blood from the patient, as tolerated (e.g. for a 70kg patient, 490 to 700 mL of whole blood will be removed) The volume of removed blood will not be replaced by the administration of intravenous fluids. Removed blood will be transfused back to participant at the end of surgery. The phlebotomized whole blood will be transfused back after liver transection regardless of blood loss.

Group II: Control (Standard of Care)Active Control1 Intervention

Standard of care (low CVP surgery). In this arm, standard anesthesia will be maintained.

0 / 11Eligibility criteria met