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

• ClinicalTrials.gov Identifier: NCT02138175
• Recruitment Status: Withdrawn
• First Posted: May 14, 2014
• Last Update Posted: February 4, 2015
• Sponsor: Atrium Health
• Information provided by (Responsible Party): Toan Huynh, Atrium Health

Study Description

Brief 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.

Condition or disease
Bleeding; Acute Blood Loss Anemia

Detailed Description:

No recruitment initiated

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Continuous Hemoglobin Monitoring: Detection of Acute Blood Loss - Accurate, Timely and Cost-effective
• Study Start Date: January 2016
• Estimated Primary Completion Date: December 2016
• Estimated Study Completion Date: January 2017

Groups and Cohorts

Group/Cohort
Patients at risk for bleeding; Patients at risk for bleeding

Outcome Measures

Primary Outcome Measures :

1. Correlation of hemoglobin level measurement between continuous hemoglobin monitor and laboratory analysis [ Time Frame: 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Adult (>18 years) patients admitted to the surgical intensive care unit for hemodynamic monitoring and serial hemoglobin measurements at high risk for bleeding (known solid organ/vascular/orthopedic injury, unexplained hypotension/tachycardia following trauma/surgery, suspected ongoing blood loss-postoperative or gastrointestinal bleeding)

Criteria

Inclusion Criteria:

• > 18 years of age
• admission to surgical intensive care unit
• suspected or high risk for ongoing blood loss

Exclusion Criteria:

-

Contacts and Locations

Locations

United States, North Carolina

Carolinas Medical Center

Charlotte, North Carolina, United States, 28203

Sponsors and Collaborators

Atrium Health

Investigators

• Principal Investigator: Toan Huynh, MD; Carolinas Medical Center

More Information

Publications:

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.

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.

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.

• Responsible Party: Toan Huynh, Director, Surgical Intensive Care Unit, Atrium Health
• ClinicalTrials.gov Identifier: NCT02138175
• Other Study ID Numbers: 03-14-02E
• First Posted: May 14, 2014
• Last Update Posted: February 4, 2015
• Last Verified: February 2015

Keywords provided by Toan Huynh, Atrium Health:

bleeding; blood loss; hemoglobin; hemoglobin monitoring; noninvasive monitoring

Additional relevant MeSH terms:

Hemorrhage; Pathologic Processes