Overview

This trial has been completed.

Condition hemorrhage
Sponsor University of Colorado, Denver
Collaborator Flashback Technologies
Start date January 2014
End date June 2016
Trial size 50 participants
Trial identifier NCT02029807, 13-2334

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Healthy adult volunteers donating blood

Primary Outcomes

Measure
Change in Intravascular volume
time frame: Day One
Change in Stroke volume
time frame: Day One
CRI trend
time frame: Day One

Eligibility Criteria

Male or female participants from 18 years up to 89 years old.

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

Additional Information

Official title Comparison of Compensatory Reserve Index to Intravascular Volume Change and Stroke Volume During Blood Donation
Principal investigator Steve Moulton, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.