CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 62 enrolled
Drug / intervention
Phlebotomy +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02548910
NCT02548910N/ACompleted

The PRICE Trial: Phlebotomy Resulting in Controlled Hypovolemia to Prevent Blood Loss in Major Hepatic Resections

Ottawa Hospital Research Institute·interventional·Posted Sep 14, 2015·Updated Mar 18, 2021

In Brief

A clinical study evaluating Phlebotomy and Citrated whole blood collection bag for Liver Neoplasms and Hepatectomy. Completed, enrolled 62 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 14, 2015
Enrollment StartApr 1, 2016
Primary CompletionMar 1, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 10.8 years ago

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.