Blood Loss, Fluid Loss
Conditions
Brief summary
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.
Interventions
DEVICEWhole blood donation supine
Subjects will undergo a 1-unit whole blood donation in a supine position
DEVICEWhole blood donation reclined
Subjects will undergo a 1-unit whole blood donation in a reclined position
Sponsors
Zynex Monitoring Solutions
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
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 |
|---|---|---|
| Impact of Subject Positioning on Percent Change of Heart Rate (HR) 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 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Supine Donation Position Whole blood donation supine: Subjects will undergo a 1-unit whole blood donation in a supine position | 60 |
| Reclined Donation Position Whole blood donation reclined: Subjects will undergo a 1-unit whole blood donation in a reclined position | 60 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Device Error | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Reclined Donation Position | Total | Supine Donation Position |
|---|---|---|---|
| Age, Continuous | 48.1 years STANDARD_DEVIATION 18.3 | 50.2 years STANDARD_DEVIATION 18.6 | 52.2 years STANDARD_DEVIATION 18.8 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 60 participants | 120 participants | 60 participants |
| Sex: Female, Male Female | 25 Participants | 54 Participants | 29 Participants |
| Sex: Female, Male Male | 35 Participants | 66 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 0 / 60 | 1 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
Primary
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).
Time frame: Recovery period following donation (10 minutes)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supine Donation Position | Impact of Subject Positioning on Percent Change of Heart Rate (HR) After Minor Blood Loss (e.g., 500mL) | 10.7 percent change | Standard Error 2.3 |
| Reclined Donation Position | Impact of Subject Positioning on Percent Change of Heart Rate (HR) After Minor Blood Loss (e.g., 500mL) | 14.7 percent change | Standard Error 2.4 |