Non-Invasive Hemoglobin Monitoring in Patients With Hemorrhage

June 27, 2016 updated by: Betty Tsuei, University of Cincinnati

Non-Invasive Hemoglobin Monitoring in the Patient With Suspected Hemorrhage

This study will evaluate the accuracy of two rapid methods of measuring hemoglobin in patients with suspected hemorrhage. These methods will be compared with standard laboratory measurements.

Study Overview

Status

Completed

Conditions

Detailed Description

Anemia and bleeding are major causes of morbidity and mortality in both surgical and nonsurgical patients. The current standard of care for monitoring patients at risk for bleeding is serial measurement of hemoglobin levels. At present, the photometric cyanmethemoglobin method is the most widely used technique for monitoring hemoglobin in the lab, and is currently the gold standard. However, this method has potential for delay before final results are obtained.

Immediate hemoglobin measurements are available with portable point-of-care devices such as the iSTAT, which can produce a measurement of hemoglobin concentration in less than 1 minute. Unfortunately, the accuracy of this device has been reported to vary with hemoglobin level, and as such may not be as accurate in detecting blood loss when compared with the gold standard of laboratory analysis.

Recently, a noninvasive, spectrophotometry-based monitoring technology has been developed. This novel technology measures the differential optical density of wavelengths of light passed through the finger in a method similar to conventional pulse oximetry. While some studies have reported that this device appears to be accurate in patients undergoing elective surgical procedures, more recent work suggests that this accuracy degrades with increased blood loss, lower oximeter signal quality and lower absolute Hgb values.

We will evaluate the accuracy of point-of-care and non-invasive SpHb measurements and utility of continuous hemoglobin monitoring in an intensive care unit setting. If these methods of rapid hemoglobin measurement can be validated in patients at risk for ongoing hemorrhage, use of this technology may result in earlier detection of ongoing hemorrhage, expedite appropriate treatment, and improve patient outcomes.

Study Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the Surgical Intensive Care Unit of University Hospital, Cincinnati will be eligible for this study if they are at risk of ongoing bleeding and require serial CBC measurements. A patient will not be eligible if he or she is:(1) less than 18 years of age, (2) a prisoner, or if (3) clinicians are unable to take pulse oximetry readings due to injuries, burns, amputations, or related problems.

Description

Inclusion Criteria:

  • admitted to surgical intensive care unit (SICU), and
  • at risk of ongoing bleeding, and
  • requires serial CBC measurements

Exclusion Criteria:

  • < 18 years of age, or
  • a prisoner, or
  • unable to have pulse oximetry readings (due to injuries, burns, amputations, or related problems)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with Suspected Hemorrhage
There is a single group of patients in this study -- those with suspected hemorrhage who satisfy the inclusion and exclusion criteria. The same set of measurements will be take from each patients and those measurements will be compared with one another to determine accuracy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CBC Hemoglobin Measurement Compared to Non-invasive Radical-7 Measurement
Time Frame: n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.

Whenever blood was drawn for laboratory measurement of serum hemoglobin, we used one drop of blood to make point-of-care measurements using the CDC and Radical-7 methods.

For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table.
n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.
CBC Hemoglobin Measurement Compared to Non-invasive iSTAT Measurement
Time Frame: n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.

When blood was drawn for laboratory measurement of serum hemoglobin, one drop of blood was used to make point of care measurements using the CBC and iSTAT methods.

For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table.
n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cincinnati

Collaborators

United States Air Force

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

October 12, 2012

First Submitted That Met QC Criteria

October 16, 2012

First Posted (ESTIMATE)

October 18, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 9, 2016

Last Update Submitted That Met QC Criteria

June 27, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tsuei-2012-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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