NCT00792597

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 7, 2013

Status Verified

March 1, 2013

Enrollment Period

1 year

First QC Date

November 14, 2008

Last Update Submit

March 6, 2013

Conditions

Blood Loss

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • See description below

    A minimum of three differences recorded during surgery

Study Arms (1)

spine or hip surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

See inclusion/exclusion criteria

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Related 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.

    PMID: 21385985RESULT

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ronald D Miller, MD

    University of California, San Francisco

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2008

First Posted

November 18, 2008

Study Start

April 1, 2009

Primary Completion

April 1, 2010

Study Completion

December 1, 2010

Last Updated

March 7, 2013

Record last verified: 2013-03

Locations

US(1)