Comparison of Three Methods of Hemoglobin Monitoring

March 6, 2013 updated by: University of California, San Francisco

Comparison of Three Methods of Hemoglobin Monitoring in Patients Undergoing Spine Revision or Hip Revision Surgery.

The purpose of this study is to compare the hemoglobin results obtained with 1) the HemoCue™, 2) the Masimo SpHb™, and 3) the UCSF Clinical Laboratory. The goal is to determine if these three values differ from each other during various levels of blood loss in the clinical care of patients for spine revision and hip revision surgery.

Study Overview

Status

Completed

Conditions

Detailed Description

See above

Study Type

Observational

Enrollment (Actual)

20

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

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California San Francisco

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

See inclusion/exclusion criteria

Description

Inclusion Criteria:

  • Male or non-pregnant female 18 y/o or older
  • American Society of Anesthesiology Classification 1, 2 or 3
  • Scheduled to undergo spine or hip revision surgery

Exclusion Criteria:

  • Pregnant or nursing
  • Patients who in the study investigators clinical judgement would not be suitable for research.

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
spine or hip surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
See description below
Time Frame: A minimum of three differences recorded during surgery
Primary outcome is based on the difference between SpHb (Masimo SpHb™ continuous hemoglobin reading ) - tHb (laboratory hemoglobin determination).
A minimum of three differences recorded during surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
See description below
Time Frame: A minimum of three differences recorded during surgery
Secondary outcome is based on the difference between a HemoCue™ derived hemoglobin determination - laboratory hemoglobin determination.
A minimum of three differences recorded during surgery

Collaborators and Investigators

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

Sponsor

University of California, San Francisco

Investigators

  • Study Director: Ronald D Miller, MD, University of California, San Francisco

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

April 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

November 14, 2008

First Submitted That Met QC Criteria

November 17, 2008

First Posted (Estimate)

November 18, 2008

Study Record Updates

Last Update Posted (Estimate)

March 7, 2013

Last Update Submitted That Met QC Criteria

March 6, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-00524

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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