Fluid Loss
Conditions
Brief summary
The study is a prospective, non-randomized, non-blinded, non-significant risk, multi-center study enrolling up to 500 healthy adult subjects consented to undergo a whole blood donation procedure. The study will involve enrolling subjects that will undergo blood donation wearing the study device (CM-1600 Device) and capture study-required physiological parameters pre-, during, and post-donation.
Interventions
DEVICECM-1600
Subjects undergoing blood donation will be connected to the CM-1600 device.
Sponsors
Zynex Monitoring Solutions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Ability to provide written 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Relative Index (RI) After Minor Blood Loss (e.g., 500mL) | Recovery period following donation (10 minutes) | The objective of this study is to determine if manual blood loss of up to 500mL of blood can be identified using the non-invasive Zynex CM-1600. This will be measured by determining the percent change in Relative Index (RI) before and after the Blood Draw. The RI is an investigational value which utilizes proprietary algorithms to combine the changes of multiple measured parameters (utilizing a weighted summation of percent change values) which are indicative of relative changes in fluid volume in adult patients into a single value. The RI is a unitless value with no set minimum or maximum, where 100 is a patient's baseline. Based on the nature of the RI itself, a direct interpretation of a positive or negative outcome cannot be derived from the absolute value, instead it could be used to monitor trending of a patient's parameters relative to their baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Blood Loss CM-1600: Subjects undergoing blood donation will be connected to the CM-1600 device. | 314 |
| Total | 314 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Procedure Notes Missing | 18 |
| Overall Study | Withdrawal by Subject | 19 |
Baseline characteristics
| Characteristic | Blood Loss | — |
|---|---|---|
| Age, Continuous | 43.8 years STANDARD_DEVIATION 21.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 314 participants | — |
| Sex: Female, Male Female | 193 Participants | — |
| Sex: Female, Male Male | 121 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 351 |
| other Total, other adverse events | 4 / 351 |
| serious Total, serious adverse events | 0 / 351 |
Outcome results
Primary
Change in the Relative Index (RI) 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 can be identified using the non-invasive Zynex CM-1600. This will be measured by determining the percent change in Relative Index (RI) before and after the Blood Draw. The RI is an investigational value which utilizes proprietary algorithms to combine the changes of multiple measured parameters (utilizing a weighted summation of percent change values) which are indicative of relative changes in fluid volume in adult patients into a single value. The RI is a unitless value with no set minimum or maximum, where 100 is a patient's baseline. Based on the nature of the RI itself, a direct interpretation of a positive or negative outcome cannot be derived from the absolute value, instead it could be used to monitor trending of a patient's parameters relative to their baseline.
Time frame: Recovery period following donation (10 minutes)
Population: 18 subjects were unevaluable; 19 subjects were withdrawn
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Blood Loss | Change in the Relative Index (RI) After Minor Blood Loss (e.g., 500mL) | 2.9 Percent change in RI | Standard Deviation 151.1 |