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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Hemorrhage

Treatments: Other: No treatment

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01448694

10-1421

Details and patient eligibility

About

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.

Enrollment: 320 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

320 participants in 1 patient group

Blood donors

Description:

Healthy volunteers who are donating a pint of whole blood

Treatment:

Other: No treatment