Liver Neoplasms Clinical Trial
— PRICE2Official title:
PRICE 2: A Phase 3 Randomized Controlled Trial of Phlebotomy Resulting in Controlled Hypovolemia to Prevent Blood Loss in Major Hepatic Resections
Verified date | March 2023 |
Source | Ottawa Hospital Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 | Active, not recruiting |
Enrollment | 440 |
Est. completion date | March 2024 |
Est. primary completion date | July 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Age <18 years - Preoperative hemoglobin <100g/L - GFR clearance <60mL/min - Abnormal coagulation parameters (not on warfarin and/or platelets count <100 X10^9/L) - Evidence of hepatic metabolic disorder - Active cardiac conditions: Unstable coronary syndromes; Severe valvular disease; and Myocardial infarction within 6 months prior to surgery - 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 - Pregnancy - Refusal of blood products - Presence of active infection - Preoperative autologous blood donation - Planned intraoperative use of cell saver |
Country | Name | City | State |
---|---|---|---|
Canada | Centre Hospitalier de l"Université de Sherbrooke | Montréal | Quebec |
Canada | Centre Hospitalier de l'Université de Montréal | Montréal | Quebec |
Canada | The Ottawa Hospital | Ottawa | Ontario |
Canada | Vancouver General Hospital | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Ottawa Hospital Research Institute |
Canada,
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Rekman J, Wherrett C, Bennett S, Gostimir M, Saeed S, Lemon K, Mimeault R, Balaa FK, Martel G. Safety and feasibility of phlebotomy with controlled hypovolemia to minimize blood loss in liver resections. Surgery. 2017 Mar;161(3):650-657. doi: 10.1016/j.surg.2016.08.026. Epub 2016 Oct 4. — View Citation
Ryckx A, Christiaens C, Clarysse M, Vansteenkiste F, Steelant PJ, Sergeant G, Parmentier I, Pottel H, D'Hondt M. Central Venous Pressure Drop After Hypovolemic Phlebotomy is a Strong Independent Predictor of Intraoperative Blood Loss During Liver Resection. Ann Surg Oncol. 2017 May;24(5):1367-1375. doi: 10.1245/s10434-016-5737-7. Epub 2017 Jan 4. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Packed Red Blood Cell Transfusion Rates | Units of packed red blood cells transfused to participants | 30 days post-operation | |
Secondary | Blood product transfusion rates | Types and amount of other blood product transfusion rates in the 30 day period following surgery. | Postoperative setting up to 30 days following surgery | |
Secondary | Intraoperative blood loss | Intraoperative blood loss is notoriously difficult to measure. It is suggested that calculation of blood loss using preoperative and postoperative hemoglobin levels in most consistently accurate. In order to minimize the risk of bias associated with any one method of intraoperative measurement of blood loss, three methods will be used independently. In the operating room, all blood and fluid aspirated from the abdomen will be measured accurately using graduated suction containers. As well, the amount of irrigation fluid will be carefully monitored and recorded. Finally, the weight of all surgical sponges will be measured. This information will be used by the surgeon and anesthesiologist to independently visually estimate blood loss, as is commonly done in clinical practice. In parallel, intraoperative blood loss will also be calculated based on an equation. | up to 90 days before surgery; and on post-operative day 2 | |
Secondary | Perioperative morbidity and mortality | Perioperative morbidity is assessed using the Dindo-Clavien scale and is defined as any deviation from the normal post-operative course. The scale (1-5) indicates the severity of an adverse event; where 1 is low (i.e. "any deviation from normal postoperative course without the need for intervention") and 5 means death of the patient (i.e. mortality). | Postoperative setting up to 30 days following surgery | |
Secondary | Changes in physiologic parameters (Central Venous Pressure) | Central venous pressure (CVP) is a physiologic parameter that measures the blood pressure in the thoracic vena cava (in cm H20) | measured during surgery (intraoperatively) | |
Secondary | Changes in physiologic parameters (Pulse Pressure Variation) | Pulse Pressure variation (in %) is a predictor of fluid responsiveness | measured during surgery (intraoperatively) |
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