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Non-invasive Hemodynamic Monitoring During Blood Donation for Developing Models of Early Blood Loss

Completed
Conditions
Hemorrhage
Interventions
Other: No treatment
Registration Number
NCT01448694
Lead Sponsor
University of Colorado, Denver
Brief Summary

This study is part of a Phase II STTR project to develop an algorithm called CipherSensor to apply feature extraction and machine learning techniques to non-invasive hemodynamic data to identify early signs of acute blood loss. The availability of this information may help to establish required interventions for treating trauma patients and battlefield casualties.

Study hypothesis: Hemodynamic changes measured non-invasively during the blood donation process can be modeled to provide early estimations of blood loss.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
320
Inclusion Criteria
  • Approved by Children's Hospital Colorado Blood Donation Center for blood donation
  • Age 18 -89 years
  • Previously donated blood (lower likelihood of vasovagal response)
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Exclusion Criteria
  • Pregnant
  • Incarcerated
  • Limited access to or compromised monitoring sites for non-invasive sensors: finger, ear and forehead sensors, oral/nasal cannula, 3 ECG electrodes.
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Blood donorsNo treatmentHealthy volunteers who are donating a pint of whole blood
Primary Outcome Measures
NameTimeMethod
Algorithm24 months

Mathematical model of early blood loss

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Children's Hospital Colorado

🇺🇸

Aurora, Colorado, United States

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