Fluid LossNCT05980013

Evaluation of Physiological Variables and Detection of Blood Loss in Healthy Adults With Different Subject Positioning by the CM-1500

A study testing Whole blood donation supine and Whole blood donation reclined in people with Fluid Loss and Blood Loss, run by Zynex Monitoring Solutions at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Fluid Loss, Blood Loss
What is being tested?: Whole blood donation supine and Whole blood donation reclined
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 2 sitesUnited States
Study dates: 28 Aug 2023to 10 Apr 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Ability to provide written informed consent
Ability and willingness to comply with the study procedures and duration requirements
18 years of age or older
Consented and eligible to undergo a single unit whole blood donation

Who cannot join

Females who are pregnant or breastfeeding
Undergone an amputation of any upper extremity
Diagnosed with dextrocardia
Subjects who have a pacemaker
Subjects with body hair density which prevents adequate application of device electrodes

Trial locations and contacts

2 sites in 1 country.

United States2 sites

SunCoast Blood Centers
Bradenton, Florida, 34211
Vitalant Research Institute
Denver, Colorado, 80230

Other trials in United States

About this study

Official title: Evaluation of Physiological Variables and Detection of Blood Loss in Healthy Adults With Different Subject Positioning by the Zynex Cardiac Monitor, Model 1500 (CM-1500)

The study is a prospective, non-randomized, non-blinded, non-significant risk study enrolling up to 60 healthy adult subjects consented to undergo a 1-unit whole blood draw procedure. Subjects will wear the study device (CM-1500) while positioned in either a supine or reclined position during the blood draw and study-required physiological parameters will be captured pre-, during, and post-donation.

Conditions: Fluid Loss, Blood Loss
Being tested: Whole blood donation supine, Whole blood donation reclined
Medical subject headings: Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Whole blood donation supineDevice
Subjects will undergo a 1-unit whole blood donation in a supine position
Whole blood donation reclinedDevice
Subjects will undergo a 1-unit whole blood donation in a reclined position

Study groups in NCT05980013
Study group	Role	What they receive
Supine Donation Position	Experimental	Not described Receives: Device: Whole blood donation supine
Reclined Donation Position	Experimental	Not described Receives: Device: Whole blood donation reclined

What is being measured

The primary outcome is the main question the study is designed to answer.

Impact of Subject Positioning on Percent Change of Heart Rate (HR) After Minor Blood Loss (e.g., 500mL)
The objective of this study is to determine if manual blood loss of up to 500mL of blood affects heart rate. This will be measured by determining the percent change in HR before and after the Blood Draw. The percent change will be calculated separately for each Arm (reclined, supine). Based on previous studies, a positive outcome would be indicated by an increase in HR (i.e., positive percent change).
Measured: Recovery period following donation (10 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Aug 202310 Apr 2024

First posted7 Aug 2023
Study start28 Aug 2023
Primary completion10 Apr 2024
Study completion10 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Fluid LossStudies of the same condition, open and under way.
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: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05980013
Sponsor's protocol ID: ZMS-1500-Pa2023
Status last verified: Apr 2025
First submitted: 26 Jul 2023
Last updated: 2 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Physiological Variables and Detection of Blood Loss in Healthy Adults With Different Subject Positioning by the Zynex Cardiac Monitor, Model 1500 (CM-1500)
ClinicalTrials.gov ID: NCT05980013
Acronym / sponsor ID: ZMS-1500-Pa2023
Conditions: Fluid Loss, Blood Loss
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Zynex Monitoring SolutionsIndustry (pharma, biotech, devices)
Study start: 28 Aug 2023 (actual)
Primary completion: 10 Apr 2024 (actual)
Study completion: 10 Apr 2024 (actual)
First posted: 7 Aug 2023 (actual)
Results: Posted 2 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Supine Donation Position	Experimental	Device: Whole blood donation supine
Reclined Donation Position	Experimental	Device: Whole blood donation reclined

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Ability to provide written informed consent
Ability and willingness to comply with the study procedures and duration requirements
18 years of age or older
Consented and eligible to undergo a single unit whole blood donation

Key exclusion criteria (5 listed)

Females who are pregnant or breastfeeding
Undergone an amputation of any upper extremity
Diagnosed with dextrocardia
Subjects who have a pacemaker
Subjects with body hair density which prevents adequate application of device electrodes

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Whole blood donation supineSubjects will undergo a 1-unit whole blood donation in a supine position	Device	Supine Donation Position
Whole blood donation reclinedSubjects will undergo a 1-unit whole blood donation in a reclined position	Device	Reclined Donation Position

Primary outcome

Impact of Subject Positioning on Percent Change of Heart Rate (HR) After Minor Blood Loss (e.g., 500mL)
Time frame: Recovery period following donation (10 minutes)
The objective of this study is to determine if manual blood loss of up to 500mL of blood affects heart rate. This will be measured by determining the percent change in HR before and after the Blood Draw. The percent change will be calculated separately for each Arm (reclined, supine). Based on previous studies, a positive outcome would be indicated by an increase in HR (i.e., positive percent change).

Results and safety

Results posted to the registry on 2 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Supine Donation Position	60	60
Reclined Donation Position	60	58

Primary outcome: Impact of Subject Positioning on Percent Change of Heart Rate (HR) After Minor Blood Loss (e.g., 500mL)

Time frame: Recovery period following donation (10 minutes). Mean (Standard Error). Unit: percent change

Measure	Supine Donation Position n = 60	Reclined Donation Position n = 58
Value	10.7 (2.3)	14.7 (2.4)

Adverse events

Time frame: Adverse event data were collected from the point of subject enrollment through a maximum of 24hrs following completion of participations (i.e., 48hrs).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Supine Donation Position	0 of 60 (0%)	0 of 60 (0%)	0 of 60
Reclined Donation Position	0 of 60 (0%)	1 of 60 (1.7%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Debra Smith, MD; PhD principal investigator

SunCoast Blood Centers

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Whole blood donation supine and Whole blood donation reclined in people with Fluid Loss and Blood Loss, run by Zynex Monitoring Solutions at 2 sites 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 4 inclusion and 5 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 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 2 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Impact of Subject Positioning on Percent Change of Heart Rate (HR) After Minor Blood Loss (e.g., 500mL) (time frame: Recovery period following donation (10 minutes)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05980013.

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 May 2025.