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

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ClinicalTrials.gov Identifier: NCT01448694
Recruitment Status : Completed
First Posted : October 7, 2011
Last Update Posted : December 3, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment Phase
Hemorrhage Other: No treatment Phase 2

Study Design

Study Type : Observational
Actual Enrollment : 320 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-invasive Hemodynamic Monitoring During Blood Donation for Developing Models of Early Blood Loss.
Study Start Date : November 2011
Primary Completion Date : October 2013
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Blood donors
Healthy volunteers who are donating a pint of whole blood
Other: No treatment
No treatment, only collecting observational data.


Outcome Measures

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


Eligibility Criteria

Information from the National Library of Medicine

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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
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:

  • 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

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): NCT01448694


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

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01448694     History of Changes
Other Study ID Numbers: 10-1421
First Posted: October 7, 2011    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by University of Colorado, Denver:
Hemorrhage

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes