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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02138175

Enrollment

Registered

2014-05-14

Start date

2016-01-31

Completion date

2017-01-31

Last updated

2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Blood Loss Anemia, Bleeding

Keywords

bleeding, blood loss, hemoglobin, hemoglobin monitoring, noninvasive monitoring

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.

Detailed description

No recruitment initiated

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results