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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01448694

Enrollment

320

Registered

2011-10-07

Start date

2011-11-30

Completion date

2014-09-30

Last updated

2014-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhage

Keywords

Hemorrhage

Brief 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.

Interventions

OTHERNo treatment

No treatment, only collecting observational data.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026