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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01448694
First received: October 5, 2011
Last updated: March 8, 2013
Last verified: March 2013
  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.

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

Primary Outcome Measures:
  • Algorithm [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Mathematical model of early blood loss


Estimated Enrollment: 400
Study Start Date: November 2011
Estimated Study Completion Date: December 2013
Estimated 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.
Other Name: No treatment

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448694

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

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01448694     History of Changes
Other Study ID Numbers: 10-1421
Study First Received: October 5, 2011
Last Updated: March 8, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Hemorrhage

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014