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Clinical Trials/NCT01448694
NCT01448694
Completed
Not Applicable

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

University of Colorado, Denver1 site in 1 country320 target enrollmentNovember 2011
ConditionsHemorrhage

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemorrhage
Sponsor
University of Colorado, Denver
Enrollment
320
Locations
1
Primary Endpoint
Algorithm
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
September 2014
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Exclusion Criteria

  • Incarcerated
  • Limited access to or compromised monitoring sites for non-invasive sensors: finger, ear and forehead sensors, oral/nasal cannula, 3 ECG electrodes.

Outcomes

Primary Outcomes

Algorithm

Time Frame: 24 months

Mathematical model of early blood loss

Study Sites (1)

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