Effectiveness of Intraoperative Cell Salvage in Aseptic Revision Total Hip Arthroplasty.

February 11, 2022 updated by: Michele Carella, University of Liege

Effectiveness of Intraoperative Cell Salvage in Aseptic Revision Total Hip Arthroplasty: a Single-center Retrospective Study

Intraoperative cell salvage is an important measure of patient blood management but its effectiveness in patients undergoing revision total hip arthroplasty remains unclear. Over the last decade, we have used intraoperative cell salvage systematically in this group of patients. However, since the use of cell salvage has a cost and requires additional resources, we decided to retrospectively investigate its usefulness in this particular indication.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • CHU de Liège

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Revision of arthroplasty was defined as the exchange of any component of the hip prosthesis.

Description

Inclusion Criteria:

  • Eligible patients were adults undergoing elective aseptic revision of hip arthroplasty at the department of orthopedic surgery of the University Hospital of Liege between 01 January 2011 and 31 December 2020.

Exclusion Criteria:

  • Patients undergoing revision for infection or with local malignancies were excluded from this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Use
Patients in whom the cell saver was effectively used
Procedure: Use of Cell Salvage in revision of total hip arthroplasty
The effective use of the cell saver was defined as the ability to re-transfuse at least 125 mL of re-suspended red blood cells with a hematocrit of 60 %.
Not Use
Patients in whom the cell saver wasn't effectively used
Procedure: Use of Cell Salvage in revision of total hip arthroplasty
The effective use of the cell saver was defined as the ability to re-transfuse at least 125 mL of re-suspended red blood cells with a hematocrit of 60 %.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cell savage use
Time Frame: during the surgical procedure
The primary outcome was the proportion of patients in whom the cell saver was effectively used (%)
during the surgical procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Re-infused
Time Frame: during the surgical procedure
Total volume of re-suspended blood re-infused (mL)
during the surgical procedure
Hemoglobin
Time Frame: during the surgical procedure
Post-operative hemoglobin level (g/dL)
during the surgical procedure
Allogenic Transfusion
Time Frame: 7 days
The need for allogenic blood transfusion (unit)
7 days
Aspirated blood
Time Frame: during the surgical procedure
The total volume of blood aspirated into the reservoir (mL)
during the surgical procedure
Fluid
Time Frame: during the surgical procedure
The total amount of fluid infused (mL)
during the surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

February 2, 2022

First Submitted That Met QC Criteria

February 11, 2022

First Posted (Actual)

February 14, 2022

Study Record Updates

Last Update Posted (Actual)

February 14, 2022

Last Update Submitted That Met QC Criteria

February 11, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Cell-salvage

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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