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Non-Invasive Hemoglobin Monitoring in Patients With Hemorrhage

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ClinicalTrials.gov Identifier: NCT01709786
Recruitment Status : Completed
First Posted : October 18, 2012
Results First Posted : August 9, 2016
Last Update Posted : August 9, 2016
Sponsor:
Collaborator:
United States Air Force
Information provided by (Responsible Party):
Betty Tsuei, University of Cincinnati

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Hemorrhage
Enrollment 88
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patients With Suspected Hemorrhage
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 88
Completed 88
Not Completed 0
Arm/Group Title Patients With Suspected Hemorrhage
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 88
Hide Baseline Analysis Population Description
Adult patients (>18 years of age) with the potential for hemorrhage and who were admitted to the Surgical Intensive Care Unit of a tertiary referral, Level I verified trauma center.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants
<=18 years
0
   0.0%
Between 18 and 65 years
69
  78.4%
>=65 years
19
  21.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants
Female
35
  39.8%
Male
53
  60.2%
1.Primary Outcome
Title CBC Hemoglobin Measurement Compared to Non-invasive Radical-7 Measurement
Hide Description

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.

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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radical-7 Hemoglobin CBC Hemoglobin
Hide Arm/Group Description:
Radical-7 hemoglobin measurement
CBC hemoglobin measurement
Overall Number of Participants Analyzed 88 88
Mean (95% Confidence Interval)
Unit of Measure: grams per deciliter
10.7
(10.6 to 10.9)
9.2
(9.0 to 9.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Radical-7 Hemoglobin, CBC Hemoglobin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments p-value is not reported since Bland-Altman is not a hypothesis testing framework.
Method Limits of agreement
Comments [Not Specified]
Method of Estimation Estimation Parameter Bland-Altman Analysis
Estimated Value 1.49
Estimation Comments Limits of agreement are -2.02 to 5.00. This is not a confidence interval because Bland-Altman is not a hypothesis testing framework.
2.Primary Outcome
Title CBC Hemoglobin Measurement Compared to Non-invasive iSTAT Measurement
Hide Description

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.

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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title iSTAT Hemoglobin CBC Hemoglobin
Hide Arm/Group Description:
iSTAT hemoglobin measurement
CBC hemoglobin measurement
Overall Number of Participants Analyzed 88 88
Mean (95% Confidence Interval)
Unit of Measure: grams per deciliter
8.5
(8.4 to 8.7)
9.2
(9.0 to 9.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection iSTAT Hemoglobin, CBC Hemoglobin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments p-value not reported since Bland-Altman is not a hypothesis testing framework.
Method Bland-Altman Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Limits of agreement
Estimated Value -0.63
Estimation Comments Limits of agreement are -3.44 to 2.18. This is not a confidence interval because Bland-Altman is not a hypothesis testing framework.
Time Frame During patient's hospital stay
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Radical-7 vs. CBC
Hide Arm/Group Description All patients: Difference between Radical-Y hemoglobin measurement and CBC hemoglobin measurement
All-Cause Mortality
Radical-7 vs. CBC
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Radical-7 vs. CBC
Affected / at Risk (%)
Total   0/88 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Radical-7 vs. CBC
Affected / at Risk (%)
Total   0/88 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Betty Tsuei, MD
Organization: University of Cincinnati
Phone: 513-558-5661
Publications:
Responsible Party: Betty Tsuei, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01709786     History of Changes
Other Study ID Numbers: Tsuei-2012-06
First Submitted: October 12, 2012
First Posted: October 18, 2012
Results First Submitted: December 14, 2015
Results First Posted: August 9, 2016
Last Update Posted: August 9, 2016