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

NCT ID: NCT01448694

Last Updated: 2014-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hemorrhage

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Blood donors

Healthy volunteers who are donating a pint of whole blood

No treatment

Intervention Type OTHER

No treatment, only collecting observational data.

Interventions

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No treatment

No treatment, only collecting observational data.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steve Moulton, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Colorado

Locations

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Children's Hospital Colorado

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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10-1421

Identifier Type: -

Identifier Source: org_study_id