Trial Outcomes & Findings for Evaluation of Physiological Variables and Detection of Blood Loss Using the Zynex Fluid Monitoring System, Model CM-1600 (NCT NCT05463198)
NCT ID: NCT05463198
Last Updated: 2024-08-13
Results Overview
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.
COMPLETED
NA
351 participants
Recovery period following donation (10 minutes)
2024-08-13
Participant Flow
Participant milestones
| Measure |
Blood Loss
CM-1600: Subjects undergoing blood donation will be connected to the CM-1600 device.
|
|---|---|
|
Overall Study
STARTED
|
351
|
|
Overall Study
COMPLETED
|
314
|
|
Overall Study
NOT COMPLETED
|
37
|
Reasons for withdrawal
| Measure |
Blood Loss
CM-1600: Subjects undergoing blood donation will be connected to the CM-1600 device.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
19
|
|
Overall Study
Procedure Notes Missing
|
18
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Blood Loss
n=314 Participants
CM-1600: Subjects undergoing blood donation will be connected to the CM-1600 device.
|
|---|---|
|
Age, Continuous
|
43.8 years
STANDARD_DEVIATION 21.4 • n=314 Participants
|
|
Sex: Female, Male
Female
|
193 Participants
n=314 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=314 Participants
|
|
Region of Enrollment
United States
|
314 participants
n=314 Participants
|
PRIMARY outcome
Timeframe: Recovery period following donation (10 minutes)Population: 18 subjects were unevaluable; 19 subjects were withdrawn
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.
Outcome measures
| Measure |
Blood Loss
n=314 Participants
CM-1600: Subjects undergoing blood donation will be connected to the CM-1600 device.
|
|---|---|
|
Change in the Relative Index (RI) After Minor Blood Loss (e.g., 500mL)
|
2.9 Percent change in RI
Standard Deviation 151.1
|
Adverse Events
Blood Loss
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Blood Loss
n=351 participants at risk
CM-1600: Subjects undergoing blood donation will be connected to the CM-1600 device.
|
|---|---|
|
General disorders
Light-headedness due to blood donation procedure
|
1.1%
4/351 • Number of events 4 • Adverse Events were recorded during subject participation and for 24hrs after participation was complete, a total of up to 27hrs.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place