Phlebotomy to Prevent Blood Loss in Major Hepatic Resections

Ottawa Hospital Research Institute62 enrolled

Overview

Major liver resection is associated with substantial intraoperative blood loss. Blood loss 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.

Major liver resection is associated with significant intraoperative blood loss. Blood loss 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. 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 phlebotomy and controlled hypovolemia, it is possible to decrease blood loss and blood transfusions. To test this hypothesis the investigators plan to randomly allocate participants to phlebotomy plus standard of care or to standard of care. Participants will be those patients undergoing elective major liver resection at the Ottawa Hospital for any indication. The primary outcome will be intraoperative blood loss. Secondary outcomes will include transfusion requirements, perioperative morbidity and mortality, safety, physiologic parameters, and feasibility elements. A total of 62 patients will be randomized. The efficacy of phlebotomy in terms of blood loss prevention will be assessed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Liver Neoplasms Hepatectomy

Interventions

PhlebotomyPROCEDURE

A central venous catheter will be inserted for every patient to measure central venous pressure, as is the standard of care in elective liver surgery. Strict aseptic technique will be maintained. A total volume of whole blood of 7-10 mL per kg of body weight will be removed, as tolerated. The volume of removed blood will not be replaced by intravenous fluid administration. Collected blood will be transfused back at the end of the liver parenchymal transection, or within 8 hours of collection.

Citrated whole blood collection bagDEVICE

Transfusion Medicine will send the requested number of whole blood collection bags labelled with the patient's name and MRN. These whole blood collection bags are used in standard practice for collection of whole blood.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Any patient being considered for a major elective liver resection will be considered for trial enrollment. Patients who are undergoing a concurrent additional abdominal or thoracic procedure (eg. colonic resection) will also be included. Exclusion Criteria: * Age \<18 years * Pregnancy * Refusal of blood products * Active cardiac conditions: unstable coronary syndromes, decompensated heart failure (NYHA functional class IV; worsening or new-onset heart failure), significant arrhythmias, severe valvular disease * History of significant cerebrovascular disease * Renal dysfunction (patients with an estimated GFR \<60 mL/min) * Abnormal coagulation parameters (INR \>1.5 not on warfarin and/or platelets count \<100 X109/L ) * Evidence of hepatic metabolic disorder (bilirubin \>35 umol/L) * Presence of active infection * Preoperative autologous blood donation * Hemoglobin \<100 g/L

Locations (1)

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

Outcomes

Primary Outcomes

Total Intraoperative Blood Loss, by Measurement of Change in Hemoglobin Levels

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.

Time frame: 1 week prior to surgery (hemoglobin level), and day two of post-op (hemoglobin again).

Trial Feasibility

Trial accrual

Time frame: through study completion, an average of 2 years

Secondary Outcomes

Blood Product Transfusion Rates

Time frame: Will be measured in the operating room and in the first postoperative week

Perioperative Morbidity (Dindo-Clavien Grade 3b of Higher) and Mortality

Time frame: Postoperative setting up to 30 days following surgery

Changes in Physiologic Parameters (CVP)

Time frame: Will be measured in the operating room

Change in Physiologic Parameters (Cardiac Index)

Time frame: Will be measured in the operating room

Data from ClinicalTrials.gov

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