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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02138175
Other study ID # 03-14-02E
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date January 2016
Est. completion date January 2017

Study information

Verified date February 2015
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of the study is to determine whether noninvasive hemoglobin monitoring is sensitive and accurate enough to detect a significant downward trend in hemoglobin in patients at risk for significant bleeding. If this can be shown, it has the potential to spare patients multiple invasive blood draws as well as allow for earlier detection of significant blood loss and therefore positively impact on patient morbidity and mortality. Additionally, it may represent significant financial cost savings in that it may allow for patients to be monitored in a non-intensive care unit setting. This will be an observational study. The continuous hemoglobin monitor will be connected to the patient and hemoglobin measurement data will be collected. Routine laboratory hemoglobin monitoring will occur concurrently at a pre-specified frequency as well as at the physician's discretion based on usual clinical information. The physician will be blinded to the continuous hemoglobin monitoring readings and therefore patient care will not be affected by the use of the monitor. Once the study has ended, the data will then be analyzed to assess for correlation between continuous hemoglobin monitoring readings and laboratory hemoglobin measurement.


Description:

No recruitment initiated


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - > 18 years of age - admission to surgical intensive care unit - suspected or high risk for ongoing blood loss Exclusion Criteria: -

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Carolinas Medical Center Charlotte North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (3)

Causey MW, Miller S, Foster A, Beekley A, Zenger D, Martin M. Validation of noninvasive hemoglobin measurements using the Masimo Radical-7 SpHb Station. Am J Surg. 2011 May;201(5):592-8. doi: 10.1016/j.amjsurg.2011.01.020. — View Citation

Coquin J, Dewitte A, Manach YL, Caujolle M, Joannes-Boyau O, Fleureau C, Janvier G, Ouattara A. Precision of noninvasive hemoglobin-level measurement by pulse co-oximetry in patients admitted to intensive care units for severe gastrointestinal bleeds. Crit Care Med. 2012 Sep;40(9):2576-82. doi: 10.1097/CCM.0b013e318258fb4f. — View Citation

Frasca D, Dahyot-Fizelier C, Catherine K, Levrat Q, Debaene B, Mimoz O. Accuracy of a continuous noninvasive hemoglobin monitor in intensive care unit patients. Crit Care Med. 2011 Oct;39(10):2277-82. doi: 10.1097/CCM.0b013e3182227e2d. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation of hemoglobin level measurement between continuous hemoglobin monitor and laboratory analysis minimum of every 6 hours after intensive care unit admission, shorter intervals if determined indicated by physician based on clinical information, over an estimated period of 3 days, or until patient transferred out of intensive care unit
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