Comparison of Physiological Variables During Blood Donation
Comparison of Compensatory Reserve Index to Intravascular Volume Change and Stroke Volume During Blood Donation
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedFirst Posted
Study publicly available on registry
January 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedDecember 2, 2016
December 1, 2016
2.4 years
December 16, 2013
December 1, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
Change in Intravascular volume
The CRI algorithm is intended to display the trend of intravascular volume changes. This is measured Day One.
Day One
Change in Stroke volume
The CRI algorithm is intended to display the trend of stroke volume changes. This is measured Day One.
Day One
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
Study Arms (1)
Blood donors
Healthy adult volunteers donating blood
Eligibility Criteria
Healthy adult volunteers donating blood
You may qualify if:
- 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)
You may not qualify if:
- Pregnant
- Incarcerated
- Limited access to or compromised monitoring sites for non-invasive finger sensors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- Flashback Technologiescollaborator
Study Sites (1)
Children's Hospital Colorado's Blood Donation Center
Aurora, Colorado, 80045, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steve Moulton, MD
University of Colorado, Denver
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2013
First Posted
January 8, 2014
Study Start
January 1, 2014
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
December 2, 2016
Record last verified: 2016-12