Comparison of Physiological Variables During Blood Donation

Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02029807
• Other study ID #: 13-2334
• Status: Completed
• Phase: N/A
• First received: December 16, 2013
• Last updated: December 1, 2016
• Start date: January 2014
• Est. completion date: June 2016

Study information

• Verified date: December 2016
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited States: Federal Government
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemorrhage

Locations

Country	Name	City	State
United States	Children's Hospital Colorado's Blood Donation Center	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Flashback Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Intravascular volume	The CRI algorithm is intended to display the trend of intravascular volume changes. This is measured Day One.	Day One	No
Primary	Change in Stroke volume	The CRI algorithm is intended to display the trend of stroke volume changes. This is measured Day One.	Day One	No
Primary	CRI trend	The CRI algorithm is intended to not require calibration, or being placed, during normal physiological conditions. This is measured Day One.	Day One	No