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Hypovolemia

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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.

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

Removal of 7-10ml/kg of blood from participant, as tolerated after patient is under anesthesia, before liver resection start time

Hypovolemic Phlebotomy

Guillaume Martel, MD, MSc, FRCSC, FACS

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.

Major liver resection is associated with significant intraoperative blood loss and blood transfusions. Blood transfusion in elective liver surgery is a key determinant of perioperative morbidity and mortality, as well as possibly long-term oncologic outcome. Whole blood phlebotomy is a simple intervention, whose aim is to decrease the central venous pressure yielding a state of relative hypovolemia and thus lead to decreased blood loss and subsequently blood transfusion. Small studies, mostly from the liver transplant literature, would suggest that phlebotomy with controlled hypovolemia can result in decreased blood loss and blood transfusion. Since blood loss is an important issue in liver surgery, and the benefits of phlebotomy and controlled hypovolemia are unknown in liver resection patients, a rigorously conducted trial in a representative population of patients undergoing liver resection is warranted, and feasible. In this proposal, it is hypothesized that by the use of hypovolemic phlebotomy, it is possible to decrease blood loss and blood transfusions. To test this hypothesis the investigators plan to randomly allocate participants to hypovolemic phlebotomy plus standard of care or to standard of care. Participants will be those patients undergoing elective major liver resection at The Ottawa Hospital, le Centre Hospitalier de l'Université de Montréal, and le Centre Hospitalier de l'Université de Sherbrooke for any indication. The primary outcome will be red blood cells transfusion up to 30 days following surgery. Secondary outcomes will include intraoperative blood loss, other blood product transfusion requirements, perioperative morbidity and mortality, safety, physiologic parameters, and feasibility elements. A total of 440 patients will be randomized across the 3 sites in Ontario and Quebec. The efficacy of phlebotomy in terms of blood loss and transfusion prevention will be assessed.

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

Upon reasonable request, ethics approval and protocol approval from steering committee

Units of packed red blood cells transfused to participants

Types and amount of other blood product transfusion rates in the 30 day period following surgery.

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.

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).

Central venous pressure (CVP) is a physiologic parameter that measures the blood pressure in the thoracic vena cava (in cm H20)

Pulse Pressure variation (in %) is a predictor of fluid responsiveness

Ottawa Hospital Research Institute

Carcinoma

Carcinoma, Hepatocellular

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

patients in this group undergoing laparoscopic hepatectomy was performed with goal-directed LCVP based on hypovolemic phlebotomy (HP)

patients in this group undergoing laparoscopic hepatectomy was performed with LCVP but no hypovolemic phlebotomy (HP)

hypovolemic phlebotomy was performed after induction of anesthesia and before the star of parenchymal division, with a goal-directed low central venous pressure drop to 5mmHg.

hypovolemic phlebotomy

Shijiang Liu, MD

Yue Wang

Shijiang Liu

The goal of this clinical trial is to learn about goal-directed LCVP based on hypovolemic phlebotomy (HP) in laparoscopic hepatectomy. The main questions it aims to answer are:

1. The safety and feasibility of HP
2. To evaluate whether HP can reduce perioperative blood transfusion ratio Participants undergoing liver resection with HP was performed by the anesthesiologist. Blood was withdrawn approximately 30 min prior to the initiation of liver parenchymal transection from central venous. The aim was to maintain the CVP between 0 to 5 cmH2O. HP volume was 5-10 mL/kg of patient body weight, generally. Participants in control group undergoing liver resection without HP.

Goal-directed LCVP Based on HP in Laparoscopic Hepatectomy

The Application of Goal-directed Low Central Venous Pressure Based on Hypovolemic Phlebotomy in Laparoscopic Hepatectomy

The primary end point of the study was the proportion of patients who required transfusion of allogeneic red blood cell products during laparoscopic hepatectomy or at any time during the hospitalization during the index admission.

how many patients have the pringle maneuver

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hypovolemic Phlebotomy to Reduce Blood Transfusions in Major Hepatic Resections	NCT03651154	Liver Neoplasms Hepatectomy Blood Transfusi... Blood Loss, Sur...	Hypovolemic Phl...	18 Years -	Ottawa Hospital Research Institute
Goal-directed LCVP Based on HP in Laparoscopic Hepatectomy	NCT05887661	Hepatocellular ...	hypovolemic phl...	18 Years -	The First Affiliated Hospital with Nanjing Medical University
Goal-directed LCVP Based on HP in Laparoscopic Hepatectomy	NCT05887661	Hepatocellular ...	hypovolemic phl...	18 Years -	The First Affiliated Hospital with Nanjing Medical University
Hypovolemic Phlebotomy to Reduce Blood Transfusions in Major Hepatic Resections	NCT03651154	Liver Neoplasms Hepatectomy Blood Transfusi... Blood Loss, Sur...	Hypovolemic Phl...	18 Years -	Ottawa Hospital Research Institute

Spots Global Cancer Trial Database for hypovolemic phlebotomy