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

This study has been completed.
United States Department of Defense
Information provided by (Responsible Party):
University of Colorado, Denver Identifier:
First received: October 5, 2011
Last updated: December 1, 2014
Last verified: December 2014

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.

Condition Intervention Phase
Other: No treatment
Phase 2

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-invasive Hemodynamic Monitoring During Blood Donation for Developing Models of Early Blood Loss.

Resource links provided by NLM:

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Algorithm [ Time Frame: 24 months ]
    Mathematical model of early blood loss

Enrollment: 320
Study Start Date: November 2011
Study Completion Date: September 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Blood donors
Healthy volunteers who are donating a pint of whole blood
Other: No treatment
No treatment, only collecting observational data.


Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy adults

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:

  • Pregnant
  • Incarcerated
  • Limited access to or compromised monitoring sites for non-invasive sensors: finger, ear and forehead sensors, oral/nasal cannula, 3 ECG electrodes.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01448694

United States, Colorado
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
United States Department of Defense
Principal Investigator: Steve Moulton, MD Children's Hospital Colorado
  More Information

Responsible Party: University of Colorado, Denver Identifier: NCT01448694     History of Changes
Other Study ID Numbers: 10-1421
Study First Received: October 5, 2011
Last Updated: December 1, 2014

Keywords provided by University of Colorado, Denver:

Additional relevant MeSH terms:
Pathologic Processes processed this record on April 28, 2017