NCT03328780

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

December 18, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2018

Completed
Last Updated

February 23, 2018

Status Verified

January 1, 2018

Enrollment Period

2 months

First QC Date

October 26, 2017

Last Update Submit

February 22, 2018

Conditions

Anemia

Keywords

preoperativeorthopedic surgery

Outcome Measures

Primary Outcomes (1)

  • Precision

    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 Outcomes (1)

  • Anemia

    through study completion, an average of 1 year

Study Arms (1)

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

Interventions

Hemocue and Rad-67 measurementDEVICE

Measurement of the hemoglobin level

Hemoglobin determination

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients scheduled for elective orthopedic surgery.

You may qualify if:

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

You may not qualify if:

  • Not able to speak the german language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hopsital Balgrist

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Oliver M Theusinger, MD

    Balgrist University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant, Priv. Doz. Dr. med.

Study Record Dates

First Submitted

October 26, 2017

First Posted

November 1, 2017

Study Start

December 18, 2017

Primary Completion

February 21, 2018

Study Completion

February 21, 2018

Last Updated

February 23, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)