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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01448694
First Posted: October 7, 2011
Last Update Posted: December 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose

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
Hemorrhage 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: October 5, 2011
First Posted: October 7, 2011
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