NCT03651154Active, not recruiting
Hypovolemic Phlebotomy to Reduce Blood Transfusions in Major Hepatic Resections
PRICE 2: A Phase 3 Randomized Controlled Trial of Phlebotomy Resulting in Controlled Hypovolemia to Prevent Blood Loss in Major Hepatic Resections
Source: ClinicalTrials.gov · Last updated 31 Jul 2025
Brief summary (registry, in English)
Major liver resection is associated with substantial intraoperative blood loss and subsequently blood transfusions. Blood transfusion in elective liver surgery is a significant factor of perioperative morbidity and mortality, as well as possibly long-term oncologic outcome. The purpose of this study is to use whole blood phlebotomy to decrease the central venous pressure, resulting in a state of relative hypovolemia. It is hypothesized that this intervention will lead to a decrease in blood loss at the time of liver resection and thus reduced blood transfusion in major liver surgeries.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 440 (estimated)
- First submitted
- 6 Jul 2018
- Start date
- 28 Sept 2018
- Primary completion date
- 30 Apr 2023
- Lead sponsor
- Ottawa Hospital Research Institute
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT03651154
What you commit to
- Study type: Interventional
- Planned participants: 440
- From 28 Sept 2018 to the primary completion date, 30 Apr 2023
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active cardiac conditions: Unstable coronary syndromes; Severe valvular disease; and Myocardial infarction within 6 months prior to surgery
Other illness
- Evidence of hepatic metabolic disorder
- History of significant cerebrovascular disease: Patients with clinically-significant stroke/CVA within the past 6 months or severe carotid stenosis (defined as \>70%)
- History of significant peripheral vascular disease: Non-revascularized with regular/ongoing claudication
- Presence of active infection
Lab values
- Preoperative hemoglobin \<100g/L
- GFR clearance \<60mL/min
- Abnormal coagulation parameters (not on warfarin and/or platelets count \<100 X10\^9/L)
Age
- Age \<18 years
Other
- Pregnancy
- Refusal of blood products
- Preoperative autologous blood donation
- Planned intraoperative use of cell saver
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier de l"Université de Sherbrooke Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Centre Hospitalier de l'Université de Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| The Ottawa Hospital Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Vancouver General Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.