Continuous Hemoglobin Monitoring: Detection of Acute Blood Loss - Accurate, Timely and Cost-effective

Bleeding Clinical Trial

Official title:

Continuous Hemoglobin Monitoring: Detection of Acute Blood Loss - Accurate, Timely and Cost-effective

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02138175
• Other study ID #: 03-14-02E
• Status: Withdrawn
• 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
• 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• Status: Withdrawn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:

-

Related Conditions & MeSH terms

• Acute Blood Loss Anemia
• Bleeding
• Hemorrhage

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