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NCT00792597 Clinical Trial

Comparison of Three Methods of Hemoglobin Monitoring

Blood Loss Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00792597
Other study ID # 10-00524
Secondary ID
Status Completed
Phase N/A
First received November 14, 2008
Last updated March 6, 2013
Start date April 2009
Est. completion date December 2010

Study information
Verified date March 2013
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

Description:

See above

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date December 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of California San Francisco San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (1)

Miller RD, Ward TA, Shiboski SC, Cohen NH. A comparison of three methods of hemoglobin monitoring in patients undergoing spine surgery. Anesth Analg. 2011 Apr;112(4):858-63. doi: 10.1213/ANE.0b013e31820eecd1. Epub 2011 Mar 8. — View Citation

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