Phlebotomy to Prevent Blood Loss in Major Hepatic Resections (PRICE)

Ottawa Hospital Research Institute

Status: Completed

Conditions: Liver Neoplasms; Hepatectomy

Treatments: Device: Citrated whole blood collection bag; Procedure: Phlebotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02548910

3588

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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62 participants in 2 patient groups

Phlebotomy

Experimental group

Description:

For patients randomized to phlebotomy, the intervention will consist of the standard of care (low CVP surgery), plus whole blood phlebotomy. Blood will be collected in citrated whole blood collection bag.

Treatment:

Device: Citrated whole blood collection bag

Procedure: Phlebotomy

Control

No Intervention group

Description:

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