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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured during surgery (intraoperatively)
Awards & highlights
PRICE2 Trial 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.Check my eligibility
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.See study design
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.
PRICE2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult scheduled for a major liver surgery or have cirrhosis and need part of my liver removed.
PRICE2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured during surgery (intraoperatively)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured during surgery (intraoperatively)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Packed Red Blood Cell Transfusion Rates
Secondary outcome measures
Blood product transfusion rates
Changes in physiologic parameters (Central Venous Pressure)
Changes in physiologic parameters (Pulse Pressure Variation)
+2 morePRICE2 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.
Find a Location
Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
561 Previous Clinical Trials
2,785,251 Total Patients Enrolled
Guillaume Martel, MD, MSc, FRCSC, FACSPrincipal InvestigatorOttawa Hospital Research Institute
1 Previous Clinical Trials
62 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.My kidney function is reduced.I refuse to receive blood transfusions.I currently have an active infection.I have donated my own blood before surgery.I am an adult scheduled for a major liver surgery or have cirrhosis and need part of my liver removed.I have a liver disorder that affects how my body processes substances.My blood does not clot properly and I am not on warfarin with a low platelet count.I have not had a heart attack or severe heart issues in the last 6 months.I have had a major stroke or severe narrowing of my neck arteries in the last 6 months.I have severe leg circulation problems that have not been treated with surgery.My surgery will include the use of a cell saver.
Research Study Groups:
This trial has the following groups:- Group 1: Hypovolemic Phlebotomy
- Group 2: Control (Standard of Care)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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