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Completed

NCT Number: NCT02029807

Comparison of Physiological Variables During Blood Donation

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.

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Key information

Conditions

Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado's Blood Donation Center

Aurora, Colorado, 80045, United States

About this study

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

  • Is intended for use by clinicians and medically qualified personnel to noninvasively display the trend of intravascular volume changes (hemorrhage)
  • Is intended for use by clinicians and medically qualified personnel to noninvasively display the trend of stroke volume changes and
  • The CRI trend value is not relative to an initial CRI reading, instead it is an actual CRI trend value that does

Who can participate

Healthy volunteers accepted: Yes

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

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)

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Change in Intravascular volume

    Time frame: Day One

    The CRI algorithm is intended to display the trend of intravascular volume changes. This is measured Day One.

  2. Change in Stroke volume

    Time frame: Day One

    The CRI algorithm is intended to display the trend of stroke volume changes. This is measured Day One.

  3. CRI trend

    Time frame: Day One

    The CRI algorithm is intended to not require calibration, or being placed, during normal physiological conditions. This is measured Day One.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Flashback Technologies

Registry information

Official study title

Comparison of Compensatory Reserve Index to Intravascular Volume Change and Stroke Volume During Blood Donation

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 8, 2014
Registry last updated
Dec 2, 2016

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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