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Phlebotomy to Prevent Blood Loss in Major Hepatic Resections

NCT02548910 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2021-03-18

Study results available
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Summary

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.

Conditions

  • Liver Neoplasms
  • Hepatectomy

Interventions

PROCEDURE

Phlebotomy

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.

DEVICE

Citrated whole blood collection bag

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.

Sponsors & Collaborators

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Guillaume Martel, MD, MSc, FRCSC, FACS · Ottawa Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02548910 on ClinicalTrials.gov