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Comparison of Three Methods of Hemoglobin Monitoring

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ClinicalTrials.gov Identifier: NCT00792597
Recruitment Status : Completed
First Posted : November 18, 2008
Last Update Posted : March 7, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Blood Loss

Detailed Description:
See above

Study Design

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Three Methods of Hemoglobin Monitoring in Patients Undergoing Spine Revision or Hip Revision Surgery.
Study Start Date : April 2009
Primary Completion Date : April 2010
Study Completion Date : December 2010
Groups and Cohorts

Group/Cohort
spine or hip surgery


Outcome Measures

Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
See inclusion/exclusion criteria
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00792597


Locations
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Study Director: Ronald D Miller, MD University of California, San Francisco
More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00792597     History of Changes
Other Study ID Numbers: 10-00524
First Posted: November 18, 2008    Key Record Dates
Last Update Posted: March 7, 2013
Last Verified: March 2013