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

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

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.

Study Overview

• Status: Completed
• Conditions: Hemorrhage
• Intervention / Treatment: Other: No treatment

• Study Type: Observational
• Enrollment (Actual): 320

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy adults

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Algorithm	Mathematical model of early blood loss	24 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: United States Department of Defense

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: October 5, 2011
• First Submitted That Met QC Criteria: October 6, 2011
• First Posted (Estimate): October 7, 2011

Study Record Updates

• Last Update Posted (Estimate): December 3, 2014
• Last Update Submitted That Met QC Criteria: December 1, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Hemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: 10-1421