Anemia in Orthopedic Surgery - Determination of Hb

February 22, 2018 updated by: Theusinger Oliver M.

Prevalence of Anemia in Orthopedic Surgery, Data Collection From Classical Laboratory Determination of Hemoglobin, by Non-invasive Hemoglobin Measurement (Rad-67™) and by HemoCue®.

Anemia prevalence in orthopedic surgery is up to 30 %. Identifying those patients prior to surgery and treating them would be ideal. Different ways of determining hemoglobin Levels are available. In this study classical laboratory determination, determination with HemoCue® and Rad-67™ will be performed to compare precision of those three methods as well as their correlation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

300

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

  • Switzerland
      • Zürich, Switzerland, 8008
        • University Hopsital Balgrist

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

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients scheduled for elective orthopedic surgery.

Description

Inclusion Criteria:

  • Age > 18 years
  • Scheduled for elective orthopedic surgery
  • Written informed consent.

Exclusion Criteria:

• Not able to speak the german language

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hemoglobin determination
In this study classical laboratory determination, determination with HemoCue® and Rad-67™ will be performed to compare precision of those three methods as well as their correlation.
Device: Hemocue and Rad-67 measurement
Measurement of the hemoglobin level

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Precision
Time Frame: through study completion, an average of 1 year
Precision of the Masimo Rad-67 versus standard hemoglobin determination in the laboratory and the Hemocue (Correlation, Standard deviation, possible significant differences).
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anemia
Time Frame: through study completion, an average of 1 year
Prevalence of anemia in elective orthopedic surgery
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Theusinger Oliver M.

Investigators

  • Study Director: Oliver M Theusinger, MD, Balgrist University Hospital

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)

December 18, 2017

Primary Completion (Actual)

February 21, 2018

Study Completion (Actual)

February 21, 2018

Study Registration Dates

First Submitted

October 26, 2017

First Submitted That Met QC Criteria

October 29, 2017

First Posted (Actual)

November 1, 2017

Study Record Updates

Last Update Posted (Actual)

February 23, 2018

Last Update Submitted That Met QC Criteria

February 22, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BASEC-Nr:2017-01361

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

Yes

product manufactured in and exported from the U.S.

Yes

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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