Blood Loss
Conditions
Keywords
blood loss
Brief summary
Non-invasive monitoring to measure changes in blood volume.
Interventions
DEVICECM 1500
Sponsors
DTarget
Zynex Monitoring Solutions
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers * Between 18-35 years of age * Weight between 130-200 pounds
Exclusion criteria
* Known cardiac disease * Recent caffeine intake * Tobacco use in the (4) hours prior to screening * Infection * Pregnancy * Hemoglobin \<13.5 g/dl
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detect by Non-invasive Monitoring a Change in Blood Volume During a Whole Blood Draw | At study completion (completion of blood draw) | Detection by non-invasive monitoring a change in blood volume (yes or no) during a whole blood draw |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| no Blood Draw CM 1500 with no blood draw
CM 1500 | 5 |
| Blood Draw CM 1500 with blood draw
CM 1500 | 45 |
| Total | 50 |
Baseline characteristics
| Characteristic | no Blood Draw | Blood Draw | Total |
|---|---|---|---|
| Age, Continuous | 25.5 years | 25.9 years | 25.7 years |
| Height | 69.2 inches | 67.9 inches | 68.6 inches |
| Region of Enrollment United States | 5 participants | 45 participants | 50 participants |
| Sex: Female, Male Female | 2 Participants | 21 Participants | 23 Participants |
| Sex: Female, Male Male | 3 Participants | 24 Participants | 27 Participants |
| Weight | 162.3 pounds | 158.4 pounds | 160.4 pounds |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 45 |
| other Total, other adverse events | 0 / 5 | 5 / 45 |
| serious Total, serious adverse events | 0 / 5 | 0 / 45 |
Outcome results
Primary
Detect by Non-invasive Monitoring a Change in Blood Volume During a Whole Blood Draw
Detection by non-invasive monitoring a change in blood volume (yes or no) during a whole blood draw
Time frame: At study completion (completion of blood draw)
Population: Number of subjects for which blood loss was detected.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| no Blood Draw | Detect by Non-invasive Monitoring a Change in Blood Volume During a Whole Blood Draw | 0 participants |
| Blood Draw | Detect by Non-invasive Monitoring a Change in Blood Volume During a Whole Blood Draw | 45 participants |