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Comparison of Three Methods of Hemoglobin Monitoring

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00792597
First received: November 14, 2008
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
  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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: November 14, 2008
Last Updated: March 6, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013