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

Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01448694
• Other study ID #: 10-1421
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2011
• Last updated: December 1, 2014
• Start date: November 2011
• Est. completion date: September 2014

Study information

• Verified date: December 2014
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: September 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemorrhage

Intervention

Other:
• No treatment
No treatment, only collecting observational data.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Algorithm	Mathematical model of early blood loss	24 months	No