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

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ClinicalTrials.gov Identifier: NCT02138175
Recruitment Status : Withdrawn (Sponsor (Masimo) suspended trial due to change in corporate ownership)
First Posted : May 14, 2014
Last Update Posted : February 4, 2015
Sponsor:
Information provided by (Responsible Party):
Toan Huynh, Atrium Health

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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



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 ]


Information from the National Library of Medicine

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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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138175


Locations
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United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
Atrium Health
Investigators
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Principal Investigator: Toan Huynh, MD Carolinas Medical Center