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Comparison of Three Methods of Hemoglobin Monitoring

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00792597
First Posted: November 18, 2008
Last Update Posted: March 7, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, San Francisco
  Purpose
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
Blood Loss

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Three Methods of Hemoglobin Monitoring in Patients Undergoing Spine Revision or Hip Revision Surgery.

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 20
Study Start Date: April 2009
Study Completion Date: December 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
spine or hip surgery

Detailed Description:
See above
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: November 14, 2008
First Posted: November 18, 2008
Last Update Posted: March 7, 2013
Last Verified: March 2013