Clinical trial NCT02029807: Comparison of Physiological Variables During Blood Donation
Official title: Comparison of Compensatory Reserve Index to Intravascular Volume Change and Stroke Volume During Blood Donation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Flashback Technologies
First posted: 2014-01-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult volunteers donating blood

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in Intravascular volume
timeFrame: Day One
measure: Change in Stroke volume
timeFrame: Day One
measure: CRI trend
timeFrame: Day One
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado's Blood Donation Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Steve Moulton, MD
role: PRINCIPAL_INVESTIGATOR
References: