HemorrhageNCT02029807
Comparison of Physiological Variables During Blood Donation
An observational study of Hemorrhage, run by University of Colorado, Denver at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemorrhage
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adult volunteers donating blood
Who may be able to join
- 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)
Who cannot join
- Pregnant
- Incarcerated
- Limited access to or compromised monitoring sites for non-invasive finger sensors
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado's Blood Donation Center
Aurora, Colorado, 80045
About this study
Official title: Comparison of Compensatory Reserve Index to Intravascular Volume Change and Stroke Volume 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.
Read more
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.
Read the 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
- 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
- Conditions
- Hemorrhage
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Blood donors | Healthy adult volunteers donating blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intravascular volume
The CRI algorithm is intended to display the trend of intravascular volume changes. This is measured Day One.
Measured: Day One
Change in Stroke volume
The CRI algorithm is intended to display the trend of stroke volume changes. This is measured Day One.
Measured: 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.
Measured: Day One
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Flashback Technologies
- Responsible party
- Sponsor
- Investigators
- Steve Moulton, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029807
- Sponsor's protocol ID
- 13-2334
- Status last verified
- Dec 2016
- First submitted
- 16 Dec 2013
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Compensatory Reserve Index to Intravascular Volume Change and Stroke Volume During Blood Donation
- ClinicalTrials.gov ID
- NCT02029807
- Acronym / sponsor ID
- 13-2334
- Conditions
- Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Flashback Technologies
- Study start
- Jan 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 8 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood donors | – | –Healthy adult volunteers donating blood |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult volunteers donating blood
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Pregnant
- Incarcerated
- Limited access to or compromised monitoring sites for non-invasive finger sensors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Moulton, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhage, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Intravascular volume (time frame: Day One). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2016.