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OpenTrials
Completed

NCT Number: NCT01448694

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.

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No treatment

Other

No treatment, only collecting observational data.

Primary outcomes

  1. Algorithm

    Time frame: 24 months

    Mathematical model of early blood loss

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Oct 7, 2011
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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