Comparison of Physiological Variables During Blood Donation

Completed

• Conditions: Hemorrhage

• Registration Number: NCT02029807
• Lead Sponsor: University of Colorado, Denver

Brief Summary

The investigators have developed a system based on a pulse oximeter, a tablet, and an algorithm running on the tablet that analyzes the pulse oximeter waveform.

The algorithm that runs on this system should be able to accurately keep track of blood loss during blood donation. The investigators will compare the algorithm with the blood loss tracked by a device called a flow meter.

The algorithm that runs on this system should be able to accurately keep track of stroke volume changes. The investigators will compare the algorithm with the stroke volume changes tracked by a device called a CCNexfin.

The algorithm that runs on this system should work whether it's in place for the whole blood donation, or if it's placed after the blood donation has started. The investigators will use two pulse oximeters for the system on each hand and compare one that is used for the whole blood donation versus one that is not used for the whole blood donation.

Detailed Description

Hypothesis: p-values for testing the hypothesis of no correlation against the alternative that there is a nonzero correlation for each subject will be calculated. The minimum average power correlation, alpha = 0.05, will be used. Correlation will be made (CRI trend during 550ml blood volume removal) using pre and post blood draw data.

Specific Aims: These data will be submitted to the FDA with the following claims: The CRI algorithm

1. Is intended for use by clinicians and medically qualified personnel to noninvasively display the trend of intravascular volume changes (hemorrhage)

2. Is intended for use by clinicians and medically qualified personnel to noninvasively display the trend of stroke volume changes and

3. The CRI trend value is not relative to an initial CRI reading, instead it is an actual CRI trend value that does

Study Timeline

• Study First Submitted: 2013-12-16
• Study Start: 2014-01
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-08
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-01
• Last Update Posted: 2016-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Subject is planning on donating blood and is approved by Children's Hospital Colorado's Blood Donation Center
• Age 18-89 years
• Previously donated blood (lower likelihood of vasovagal response)

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Exclusion Criteria

• Pregnant
• Incarcerated
• Limited access to or compromised monitoring sites for non-invasive finger sensors

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Stroke volume	Day One	The CRI algorithm is intended to display the trend of stroke volume changes. This is measured Day One.
Change in Intravascular volume	Day One	The CRI algorithm is intended to display the trend of intravascular volume changes. This is measured Day One.
CRI trend	Day One	The CRI algorithm is intended to not require calibration, or being placed, during normal physiological conditions. This is measured Day One.

Trial Locations

Locations (1)

Children's Hospital Colorado's Blood Donation Center; 🇺🇸 Aurora, Colorado, United States